Cannabis-Testing-Lab-Bench-top-Mobile-Sterilizer

Bench Top Autoclave Sterilizing Appliance for Cannabis Testing Labs

play

This sterilizer has stylish aesthetics and enhanced features that perfectly complements today’s Cannabis Testing Lab Workbench. Only $1,299.

The Bench Top Autoclave Sterilizing Appliance for Cannabis Testing Labs

If you need to sterilize liquids and media or eliminate the risk of cross infection through contaminated tools or solutions, then this is the autoclave that offers a Cannabis Testing Labs a professional, reliable, safe and affordable solution.

A controlled cycle profile ensures that, when used a convenient and personalized solution to media sterilization and a flexible alternative to larger, communal autoclaves.

Key Features

  • Suitable for media sterilization and also destructive sterilization
  • Small footprint – occupies only a small area of bench space
  • Easy to use with a simple, single button cycle start
  • Fully compliant to all relevant standards
  • Lightweight and portable
  • Works with standard 230 or 110V electrical supply
  • Optional printer for data capture
  • Only one consumable item – the sealing gasket

    For More Information Call 800-801-9934 or email Info@Sterilizers.com

Safety as standard

  • Built-in safety mechanism which prevents the lid from being opened until the internal temperature has fallen below 80°C.
  • Multiple safety devices protect against over temperature and over pressure situations
  • Eliminates the risk of thermal shock to superheated vessels, ensuring that glassware is protected
  • Controls cooling to ensure that there is no boil over of liquids

Fully Automatic 
With one fixed cycle pre-programmed and fully automatic.
There is no need for operator programming of cycle parameters. There is no need for constant supervision of the unit during the cycle meaning staff are free to undertake other activities. Special software accurately controls the temperature and pressure during the cycle, ensuring that operating parameters are accurate and cycle profiles are repeatable.

Reliability This Bench Top Autoclave offers an unrivaled combination of ease of use, cost effectiveness and the highest level of reliability. This ensures that your cannabis testing lab sterilizer, if maintained and used in accordance with the recommended procedures, will give many years of safe and repeatable use.

Cannabis-Testing-Lab-Bench-top-Mobile-Sterilizer

What You Need to Know About Legal Marijuana

By Barry Feldman
It is impacting laws, marketing, and the U.S. snacking industry.

ALEXANDRIA, Va.—U.S. consumers are interested in cannabis, and laws are changing to meet consumer demands, according to Nielsen, the research organization.

Recently, Illinois lawmakers approved recreational marijuana use for adults, and sales of cannabis products containing the psychoactive element, THC, will be on the market beginning in January 2020. Despite its classification as a Class 1 controlled substance under federal law, 11 states and Washington D.C. have legalized recreational use of marijuana. That presents big opportunities for the American food and beverage market, especially the snack and confectionery category.

America is a snacking nation. Within the U.S., sales of both salty and sweet snacks have increased during the 52 weeks ended April 27, 2019, with salty snacks reaching sales of $29.9 billion and sweet snacks hitting $6.5 billion. But could the “munchies” driven by marijuana use boost sales even more?

Marijuana consumption is proven to increase a person’s appetite and the enjoyment of food. Sales data from within the U.S. Census divisions where cannabis has been legalized support the munchies’ effect. Nielsen data show that growth rates for both candy and snacks are rising faster in these areas than in geographies where cannabis has yet to be legalized for recreational use.

For manufacturers and retailers, American consumers’ hunger for snacks alongside legal cannabis consumption can present an opportunity for cross-selling, but it’s not just cannabis alone that could affect the industry. Edible hemp-based cannabidiol (CBD) products, including the cannabinoid compound in marijuana with little to no THC, present a $6 billion opportunity for the food and beverage industry. Nielsen plans to continue monitoring the impact of marijuana and edible CBD products and how it impacts the snacking industry.
CBD seems to be available almost everywhere and marketed as a variety of products, including drugs, food, dietary supplements, cosmetics, pet food and other animal health products.

But the U.S. Food and Drug Administration (FDA), maintains that CBD products that are ingested or for which health claims are made must be FDA-approved before they can be offered for sale. The FDA recognizes the public’s interest in cannabis and cannabis-derived compounds, but before it approves CBD products it wants answers to questions about the science, safety and quality of products containing CBD. The FDA is seeking feedback following a recent FDA hearing through a public docket that is open for comment until July 16, 2019.

Currently, only one prescription drug product, which is used to treat rare forms of epilepsy, is FDA approved. No other CBD products have received an FDA evaluation regarding safety and effectiveness for specified health issues, the proper dosages, how they could interact with other drugs or foods or whether they have dangerous side effects or other concerns.

The FDA wants to know specifically:

·        The effects CBD could cause in the body, such as toxicity to the liver, when someone ingests CBD regularly over a long period of time. It’s unclear how risks might be managed when CBD is used widely, without medical supervision and not in accordance with FDA-approved labeling.

·        The cumulative exposure to CBD if consumers use it across a broad range of consumer products. For example, what happens if you eat food with CBD in it, use CBD-infused skin cream and take other CBD-based products on the same day? What if you use these products daily for a week or a month?

·        The effects of CBD on special populations (e.g., the elderly, children, adolescents, pregnant and lactating women) or types of animals (e.g., species, breed, or class), including pets.

Authorities are concerned that misleading or false claims regarding CBD products may lead consumers to put off getting important medical care. The agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to contain lower levels of CBD than claimed.

For more information:

Barry Feldman
Partner, (HLA) Harold Levinson Associates
Office 631 962-2400 Ext.1111
Email: bfeldman@hladistributors.com
Visit HLA on Line at: www.hladist.com

http://www.hladistributors.com/virtual_tour.html

Market Forge Sterilmatic Large Cannabis Testing Lab Sterilizer

Market Forge STERILMATIC STEAM STERILIZERS for Cannabis Testing Labs

It may be small on the outside, but this Market Forge Sterilizer features the largest capacity in the most compact space.and perfectly complements today's Cannabis Testing Lab, Integrated Marijuana,  and Hemp Growers using tissue culture to clone mother plants. $13,999.
QUESTIONS?  CALL OUR 24-HOUR HELP DESK (877) 836-4180

The STERILMATIC STEAM STERILIZERS Steam Autoclave Appliance

Economical, reliable and simple to operate, the versatile Sterilmatics provides the highest standards of sterilizing performance in a number of facilities, such as, Laboratories, Tissue Culture Prep Rooms, Product Processing Plants, and more.

Sterilize glass beakers, pipettes, test tubes and flasks. Metal and plastic instruments, syringes, needles, brushes, rubber gloves, catheters, rubber tubing, dressings, linens, petri dishes and more.

DIGITAL STERILIZER Standard Features

  • LCD display screen; monitor temperature, time and pressure
  • Select temperature in °F (PSI) or °C (kPa)
  • Sterilizing temps can range from 225°F (107°C) to 250°F (121°C)
  • Choose from fast or slow exhaust
  • Built-in data recorder and printer
  • Programmable buttons to store up to 3 temp/time/venting cycle
    parameters
  • Maintain a set temperature with a built-in microprocessor
  • Electric steam trap
  • Removable pan supports
  • For use at altitudes up to 6500 ft
  • 18-3/4” wide x 28-5/8” high x 31” deep
    • (56-1/4” high on optional stand

Made in America  

MARKET-FORGE-DIGITAL-Cannabis-Testing-Lab-STERILIZER-USA-Made

Market Forge is ideally suited for Cannabis Testing Labs

For More Information Call 800-801-9934 or email Info@Sterilizers.com

Model - STM-ED*
Digital sterilmatic (microprocessor controlled) with programmable time, temperature and venting (230°-250°F / 110°-121°C)

Model- STM-EDX**
Export model digital sterilmatic (microprocessor controlled) with programmable time, temperature and venting (230°-250°F /110°-121°C)

* These models are available in 208, or 240 Volts, 60Hz, 1 or 3 ph
** Export models are available in 220/380 Volts, 50Hz, 1 or 3 ph 4 wire or 240/415 Volts, 50Hz, 1 or 3 ph 4 wire
Adjustable feet are included as standard in all units

OPTIONS & ACCESSORIES

Part 95-6060 - Stainless Steel Stand with Adjustable Shelf & Feet - 28” High* 23/10 $1,100
Part 95-6054 - Extra Shelf (For Stand Listed Above)
Part 10-1203 -12” x 20” x 2-1/2” Perforated Tray (Unit will hold three of this size)
Part 10-1204 - 12” x 20” x 4” Perforated Tray (Unit will hold (2) of these, as well as (1) - 2-1/2” tray)
Part 10-1205 - 12” x 20” x 6” Perforated Tray (Unit will hold (1) of these, as well as (1) - 2-1/2” tray)
Part 10-1228 - 12” x 20” x 2-1/2” - Wire Basket
Part 10-1229 - 12” x 20” x 4” - Wire Basket
Part 95-0436 - Exhaust Condenser (Can’t be connected to outside vent)
Part 95-3629 - Exhaust Condenser 240V, 50/60 Hz (Can be used with “Export” Sterilizers)
Part 95-6061 - Spare Parts Kit (STM-E & STM-EL Models)
Part 95-6062 - Spare Parts Kit (STM-EX & STM-ELX Models) Export
Part 95-6233 - Recording Thermometer (Provides Continuous 120 Volts / 60 Hz)
Part 95-6234 - Recording Thermometer (Provides Continuous 230 Volts / 50 Hz) Export
Part 10-7933 - Replacement 24 Hour Recording Chart (Fahrenheit)
Part  08-6244 - Replacement 24 Hour Recording Chart (Celsius) Export
Part * Sterilmatic overall height with stand is 55-1/4” (1403mm) for analog units and 56-1/4” (1429mm) for digital units

Cannabis Testing Lab Autoclave Sterilizer SALE

Featured Sterilizer On Sale

Factory Demo Cannabis Testing Lab Autoclave Sterilizer SALE 

Very special refurbished price of $7,100. New factory warranty. Versatile and perfect Sterilizer for both Cannabis Testing Labs and Marijuana Tissue Culture Operations.

 Market Forge Factory Demo Cannabis Testing Lab Autoclave Sterilizer SALE . Never used, very special price of $6000 (50% Saving). New factory warranty. Perfect for tissue culture solutions, glassware and instrument sterilization.

Market Forge Autoclave Sterilizer for Cannabis and Testing Labs and Marijuana Tissue Culture Operation

The Market Forge Sterilmatic STM autoclave is a full size autoclave, roomy and spacious with many features. This unit preheats quickly, reaching sterilizing temperature in 8 to 10 minutes from cold start, 3 to 7 minutes in continued use.It will automatically maintain set temperature with a release pressure and shut off power supply at end of cycle.

  • All controls are mounted on the front of the apparatus for ease of use.
  • This instrument contains a 16" dia. x 26" deep
  • The chamber is made of clad aluminum
  • Exhaust speed dial with
    • Fast (1 minute for instruments and glassware)
    • Slow (10 minutes for liquids) settings
    • 0 - 60-minute timer.
  • The Sterilamatic will heat up to a temperature of 121 C (250 F).
  • The exterior is made of stainless steel for ease of cleaning and sanitation.
  • Doors lock automatically and cannot be opened until pressure is exhausted
  • Incorporated are low-water cutoffs and safety valves

Electricians take note: This sterilizer is not equipped with cord set. You will need to either create a cord set, or create a hard-wire connected to a circuit breaker box. All you need to know from us is what voltage the machine is to be connected to and the phase (single phase, or three phase), which is listed above. Condenser coil (pn MZZ100705) is an option.

The Market Forge Sterilmatic STM Autoclave Owner's Manual link can be found here.

Click here to view Owner's Manual

ELECTRIC STERILMATIC STERILIZER Table of Contents

HVP-50 Top-Loading Autoclave With Fully Automatic Drying.

About Hirayama Sterilizers-

Q Who is Hirayama Sterilizers

  • Hirayama Manufacturing Corporation is based in Japan engages in manufacture of autoclaves. The company was founded in 1924 and is based in Kasukabe-shi, Japan. Hirayama Manufacturing Corporation operates as a subsidiary of Yagami Inc.
  • They make Vertical Autoclaves, Desktop Autoclaves, Horizontal Autoclaves, and Medicine Bottle Autoclaves
  • Hirayama's top-loading autoclaves are labeled and distributed for research use only.

Q What kind of companies use Hirayama Sterilizers?

  • Hirayama’s sterilizers are used by physicians, hospitals, universities, pharmaceutical, biotech companies, cannabis testing labs, chemical and food industries, inspection centers, public health centers and government agencies throughout the world.

Tuttnauer EL Laboratory Z-MAR-3870EL-D On Sale

About Tuttnauer Sterilizers

Tuttnauer is an Israeli company and all the sterilizers are made in their factories in Jerusalem. They are shipped all around the world. They also have the highest quality and meet or exceed all the US and European standards. They are built with safety in mind and are ASME stamped. They have UL approved components and are FDA approved. They all come with a one-year warranty on the sterilizer and a fifteen-year warranty on the chambers

Who is Tuttnauer Sterilizers
Q What size are Tuttnauer Sterilizers
  • Small, Medium, and Large - Call (800) 801-9934 For Expert Advice and the Best Price
What size are Tuttnauer Sterilizers

Q What are the advantages of a Large Tuttnauer Sterilizers?
  • It can handle more equipment and it is used in high-volume hospitals and laboratories where there is a call for greater volume of instrument sterilization.

 

What are the advantages of a Large Tuttnauer Sterilizers
Q Are Large Tuttnauer Sterilizers Heat or Steam?
  • All sterilizers that are large either have a steam generator or have steam.
Q Do Large Tuttnauer Sterilizers Need Plumbing ?
  • Steam sterilizers that have a large size also consume a considerable amount of water. They need to be hooked up so that the water can be heated, turned into steam, and then sterilize the instruments immediately within the chamber.
Do Large Tuttnauer Sterilizers Need Plumbing

Q Do Large Tuttnauer Sterilizers Need Installation?

Yes, they are a bit complicated so they will need an installation by a professional. And they will need electricity running between 220 volts and 480 volts. It will also need floor drains so that water can be evacuated after the cycle.

Do Large Tuttnauer Sterilizers Need Installation

Is Tissue Culturing the Future of Cannabis Cultivation?

The Cannabis Prep Room Needs to be Sterile. Call for Expert Advice

Many horticultural experts say tissue cultures is a far superior method to propagate and preserve a plant’s genetics according to this recent article in Marijuana Business Magazine, Scaling New Heights. Included in the article is a checklist about “Setting Up Shop” and includes autoclaves and a necessary tool as they are used for sterilizing instruments, glassware and media that will hold the tissue cultures.

An advantage of a tissue-culture operation is that it requires less space than clones do. This article estimates that outfitting a tissue-culture space costs about 75% more than a space needed to produce an equivalent number of clones; the tissue-culture space, however, will be roughly 10% the size of the space needed for clones. For example, if you wanted to make 2 million clones yearly with traditional methods, you would need a 30,000-square-foot space. To make 2 million clones with tissue cultures, you need only 2,000-3,000 square feet, Guelich estimated.

These advantages make tissue culture conducive to multiple different business models.

Large Canadian cultivators such as Canopy Growth and AgMedica Bioscience are setting up tissue-culture operations to produce at least some of their plants. They also see it as a way to outproduce the competition in a national marketplace, industry insiders said.

Others have harnessed tissue culture to start nurseries that provide cannabis plants to farmers. Front Range Bio­sciences in Colorado, for example, uses tissue culture to breed high-CBD strains and recreational-market strains, then micropropagates those to produce young plants that are sold to farmers. Front Range CEO Jonathan Vaught said the company has dozens of marijuana customers in California and Colorado, plus dozens of clients in the United States and Canada are buying the company’s plants that were bred and propagated for CBD.

While tissue culture is high-tech and can take cannabis production to new levels, it’s still a relatively new tool in marijuana that the industry is learning about.

Call Sterilizers.com for the best price and expert advice #sterilization, #instrumentation, #autoclave, #tissueculture

State Testing Regulations

Here are links to the rules and regulations created by the states that have legalized marijuana. Please check NORML for more information: http://norml.org/laws

State cannabis laws may change. Please review to the state’s website for the most up to date information.

Alaska

Alaska Administrative Code: 3 AAC 306. Alaska Statutes: AS 17.38

Arizona

Arizona Revised Statutes A.R.S. §36-2801

Arkansas

Amendment No. 98 of the Constitution of the State of Arkansas of 1874, The Medical Marijuana Amendment of 2016.

  • Arkansas Medical Marijuana Commission - Click Here
  • Arkansas Department of Health Medical Marijuana Program - Click Here

California

Medical Cannabis Regulation and Safety Act: Assembly Bill 266, Assembly Bill 242, Senate Bill 643, Proposition 64

Colorado

Colorado Revised Statutes: Medical Marijuana Code: C.R.S. 12-43.3-101, Retail Marijuana Code: C.R.S. 12-43.4-101

Connecticut

Connecticut General Statutes: Chapter 420f Section 21a-408

Delaware

Title 16 Health And Safety Delaware Administrative Code: 4470 State of Delaware Medical Marijuana Code

  • State of Delaware Medical Marijuana - Code 4470

District of Columbia

Washington D.C. Regulations Act 13-138, "Legalization of Marijuana for Medical Treatment Initiative of 1998"

Florida

Article X Section 29 of the Florida Constitution and Florida Statutes 381.986

Hawaii

Hawaii Revised Statutes Chapter 329-121 to 329-128

Illinois

Administrative Code: Title 8 Chapter 1 Part 1000 Compassionate Use Of Medical Cannabis Pilot Program

Maine

Maine Revised Statutes Title 22 Chapter 558-C: Maine Medical Use Of Marijuana Act

  • Maine Medical Use of Marijuana Program (MMMP) - Click Here

Maryland

Code of Maryland Regulations (COMAR): Title 10, Subtitle 62 Natalie LaPrade Medical Cannabis Commission

  • Natalie LaPrade Medical Cannabis Commission – Click Here

Massachusetts

Commonwealth of Massachusetts Regulations: 105 CMR 725.000 Implementation Of An Act For The Humanitarian Medical Use Of Marijuana

Michigan

 Michigan Compiled Laws: Section 333.26424 Michigan Medical Marihuana Act

  • Bureau of Medical Marihuana Regulation - Click Here

Minnesota

Minnesota Administrative Rules Chapter 4700, Medical Cannabis

Montana

Montana Marijuana Bill (SB0333)

Nevada

Nevada Revisited Statutes Chapter 453A Medical Used of Marijuana

New Hampshire

New Hampshire Revised Statutes: 126-X:10 Use Of Cannabis For Therapeutic Purposes

New Jersey

New Jersey Administrative Code (N.J.A.C.) 8:64, New Jersey Statutes Annotated (N.J.S.A.) 24:6I

  • Medicinal Marijuana Program - Rules

New Mexico

Lynn and Erin Compassionate Use Act, N.M. Stat. Ann. § 30-31C-1, N.M. Stat. Ann. §26-2B-3(F)

New York

Compassionate Care Act, New York Codes, Rules and Regulations: Volume D Title 10 Part 1004 Chapter XIII - Medical Use of Marihuana

North Dakota

North Dakota Senate Bill 2344, Statutory Measure No. 5

Ohio

Ohio Revised Code (O.R.C.) 3796

Oklahoma

Ballot Question 788. Oklahoma Administrative Code: OAC 475:10-1-9(a).

Oregon

Oregon Administrative Rules: OAR 333-007-0300, OAR 333-007-2000, OAR 333-064-0100 & OAR 333-064-0110)

  • Marijuana Testing Requirements - Click Here
  • Marijuana Labeling, Concentration Limits and Testing - Click Here

Pennsylvania

Medical Marijuana Act - Enactment, Act of Apr. 17, 2016, P.L. 84, No. 16

Rhode Island

The State of Rhode Island General Laws R21-28

Vermont

State of Vermont Executive Department Executive Order - NO. 15-178

  • Vermont Marijuana Commission - Click Here
  • Executive Order Number 15-17 - Governor’s Marijuana Advisory Commission - Click Here
  • Cannabis TestingforPublicSafety– BestPracticesforVermontAnalyticalLaboratories - Click Here

Washington

Revised Code of Washington (RCW) Title 69 Chapter 69.51A

West Virginia

Chapter 16A. Medical Cannabis Act

  • Senate Bill 386 Chapter 16A - Click Here
  • West Virginia Office of Medical Cannabis - Click Here
  • West Virginia Office of Laboratory Services - Click Here
TUTTNAUER 3870EL-D - STERILIZER 15

New Sterilizer Setup

After you have received your new sterilizer from sterilizers.com. Follow these easy steps to set up your new Cannabis Testing Lab Sterilizer. Be sure to schedule weekly Biologic monitoring,  monthly cleaning with AlfaClean, and an annual onsite service call by a certified sterilizer repair technician 

To make sure that you get the most out of your cannabis Testing Lab sterilizer, Sterilizers.com suggests you contact them first make sure you get the right size and type sterilizer for your Cannabis Testing Lab needs.

Once your new Cannabis Testing Lab sterilizer arrives carefully unpack it and place it on the counter where it will be used. Be sure to leave an inch or so against the wall to allow for Optimum airflow, now you're ready to plug it in and begin setting it up according to the attached instructions. If your sterilizer is a tabletop model make sure that you have distilled water for the sterilization process.

After you have read the enclosed instructions that came with your Cannabis Testing Lab sterilizer it's time to run your first cycle. The first thing to do is to fill the reservoir with the distilled water and then start the sterilization process. Use one of your class 5 integrators in the first cycle to validate your Cannabis Testing Labs sterilizers sterility.

Once the first cycle is complete, the item sterilized and check the integrator for a pass indication. Your new Cannabis Testing Labs Sterilizer should be ready for use. 

Every week you should want a biological indicator test, every month you should clean your sterilizer with Alpha clean and you should plan on annual service calls by trained and certified sterilizer repair technicians. If You have any question call sterilizers.com and have an expert give you the answer you need.

Cannabis-Testing-lab-Sterilizer-Supplies

Cannabis Testing Lab Sample Checklist

Here is example of a checklist developed the state of Washington for Cannabis Testing Labs to use as practice so they pass audits that check for compliance. Accreditation and other requirements are required in Washington prior to conducting required quality assurance tests.

ORGANIZATION
Completed by:
Reviewed by:
Document
Reference
Y N NA Comments
1 The laboratory or the organization of which it is a part of shall be an entity that can be held legally responsible. - - - - -
2 The laboratory conducting third-party testing shall have no financial interest in a licensed producer or processor for which testing is being conducted. - - - - -
- - - - -
3 The laboratory shall have policies and procedures to ensure the protection of its client's confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results. - - - - -
4 In every instance where the lab references certification status they shall clearly indicate which tests they are currently certified for. - - - - -
5 The laboratory is responsible for all costs of initial certification and ongoing site assessments. - - - - -
6 The laboratory must agree to site assessments every year for the first three years to maintain certification. Beginning year four of certification, on-site assessments will occur every two years to maintain certification. - - - - -
7 The laboratory must allow WSLCB staff or their representative to conduct physical visits and check I-502 related laboratory activities at any time. - - - - -
8 The laboratory must report all test results directly into WSLCB's traceability system within twenty-four hours of completion. Labs must also record in the traceability system an acknowledgment of the receipt of samples from producers or processors and verify if any unused portion of the sample was destroyed or returned to the customer. - - - - -
HUMAN RESOURCES
Completed by:
Reviewed by:
Document
Reference
Y N NA Comments
9a. Job descriptions for owners and all employees. A written and documented system detailing the qualifications of each member of the staff including any specific training requirements applicable to analytical methods. - - - - -
b. Specialized training such as by vendors, classes granting CEUs, etc., shall be documented in each training file. - - - - -
10 Qualifications of owners and staff: CVs for staff on file. - - - - -
a. Have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations. - - - - -
b. Documentation that the scientific director meets the requirements of WSLCB rules. - - - - -
c. Chain of command, personnel organization/flow chart, dated and signed by the laboratory director. - - - - -
d. Written documentation of delegation of responsibilities in the absence of the scientific director and management staff (assigned under chapter 314-55WAC as related to quality assurance testing). - - - - -
e. Documentation of employee competency (DOC): Prior to independently analyzing samples, and on an annual, ongoing basis, testing personnel must demonstrate acceptable performance on precision, accuracy, specificity, reportable ranges, blanks, and unknown challenge samples (proficiency samples or internally generated quality controls). Dated and signed by the laboratory director. - - - - -
f. The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. - - - - -
g. When using staff who are undergoing training, appropriate supervision shall be provided. - - - - -
h. Personnel performing specific tasks shall be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as necessary. - - - - -
i. The management shall authorize specific personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment. - - - - -
j. The laboratory shall maintain records of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. - - - - -
k. Successful training (in-house courses are acceptable) in specific methodologies used in the laboratory shall be documented. - - - - -
l. Designate a quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the quality system is implemented and followed; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources. - - - - -
m. The laboratory shall delegate responsibilities for key managerial personnel to be acted upon in cases of absence or unavailability. - - - - -
n. The laboratory shall provide adequate supervision of testing staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or calibration results. - - - - -
11 Standard operating procedure for the following: - - - - -
a. Instructions on regulatory inspection and preparedness. - - - - -
b. Instruction on law enforcement interactions. - - - - -
c. Information on U.S. federal laws, regulations, and policies relating to individuals employed in these operations, and the implications of these for such employees. - - - - -
d. Written and documented system of employee training on hazards (physical and health) of chemicals in the workplace, including prominent location of MSDS or SDS sheets and the use of appropriate PPE. - - - - -
e. Written and documented system on the competency of personnel on how to handle chemical spills and appropriate action; spill kit on-site and well-labeled, all personnel know the location and procedure. - - - - -
f. Information on how employees can access medical attention for chemical or other exposures, including follow-up examinations without cost or loss of pay. - - - - -
g. Biosafety at a minimum covering sterilization and disinfection procedures and sterile technique training. - - - - -
Document
Reference
Y N NA Comments
12 As appropriate, laboratory operations covered by procedures shall include, but not be limited to, the following: - - - - -
a. Environmental, safety and health activities; - - - - -
b. Sample shipping and receipt; - - - - -
c. Laboratory sample chain of custody and material control; - - - - -
d. Notebooks/logbooks; - - - - -
e. Sample storage; - - - - -
f. Sample preparation; - - - - -
g. Sample analysis; - - - - -
h. Standard preparation and handling; - - - - -
i. Post analysis sample handling; - - - - -
j. Control of standards, reagents and water quality; - - - - -
k. Cleaning of glassware; - - - - -
l. Waste minimization and disposition. - - - - -
13 The following information is required for procedures as appropriate to the scope and complexity of the procedures or work requested: - - - - -
a. Scope (e.g., parameters measured, range, matrix, expected precision, and accuracy); - - - - -
b. Unique terminology used; - - - - -
c. Summary of method; - - - - -
d. Interferences/limitations; - - - - -
e. Approaches to address background corrections; - - - - -
f. Apparatus and instrumentation; - - - - -
g. Reagents and materials; - - - - -
h. Hazards and precautions; - - - - -
i. Sample preparation; - - - - -
j. Apparatus and instrumentation setup; - - - - -
k. Data acquisition system operation; - - - - -
l. Calibration and standardization; - - - - -
m. Procedural steps; - - - - -
n. QC parameters and criteria; - - - - -
o. Statistical methods used; - - - - -
p. Calculations; - - - - -
q. Assignment of uncertainty; - - - - -
r. Forms used in the context of the procedure. - - - - -
s. Document control with master list identifying the current revision status of documents. - - - - -
FACILITIES AND EQUIPMENT Document
Reference
Y N NA Comments
14 Allocation of space: Adequate for number of personnel and appropriate separation of work areas. - - - - -
15 Arrangement of space. - - - - -
a. Allows for appropriate work flow, sampling, lab space separate from office and break areas. - - - - -
b. Employee bathroom is separate from any laboratory area. - - - - -
16 Adequate eyewash/safety showers/sink. - - - - -
17 Procurement controls. - - - - -
a. The laboratory shall have procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations. Procedures covering reagents and laboratory consumables shall exist for the purchase, receipt, storage, and disposition of expired materials. - - - - -
b. The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned. - - - - -
i. Reagents and standards shall be inspected, dated and initialed upon receipt, and upon opening. - - - - -
ii. Calibration standards and analytical reagents shall have an expiration or reevaluation date assigned. - - - - -
iii. Solutions shall be adequately identified to trace back to preparation documentation. - - - - -
c. Prospective suppliers shall be evaluated and selected on the basis of specified criteria. - - - - -
d. Processes to ensure that approved suppliers continue to provide acceptable items and services shall be established and implemented. - - - - -
18 Subcontracting. - - - - -
a. The laboratory shall advise the customer of the subcontract arrangement in writing, including the subcontractors' accreditation credentials under chapters 69.50RCW and 314-55 WAC. - - - - -
b. The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with chapter 314-55 WAC for the work in question. - - - - -
c. When there are indications that subcontractors knowingly supplied items or services of substandard quality, this information shall be forwarded to appropriate management for action. - - - - -
19 Utilities (items verified upon on-site inspection). - - - - -
a. Electrical: - - - - -
i. Outlets: Adequate, unobstructed, single-use, multiplug adaptors with surge control; - - - - -
ii. Single-use extension cords; - - - - -
iii. Ground fault circuit interrupters near wet areas. - - - - -
b. Plumbing: - - - - -
i. Appropriateness of sink usage: Separate sinks for work/personal use; - - - - -
ii. Adequate drainage from sinks or floor drains; - - - - -
iii. Hot and cold running water. - - - - -
c. Ventilation: - - - - -
i. Areas around solvent use or storage of solvents or waste solvents; - - - - -
ii. Vented hood for any microbiological analysis - Class II Type A biosafety cabinet as applicable. - - - - -
iii. Fume hood with appropriate ventilation. - - - - -
d. Vacuum: Appropriate utilities/traps for prevention of contamination (as applicable). - - - - -
e. Shut-off controls: Located outside of the laboratory. - - - - -
20 Waste disposal: Appropriate for the type of waste and compliant with WAC314-55-097 Marijuana waste disposal—Liquids and solids. - - - - -
21 Equipment. Equipment and/or systems requiring periodic maintenance shall be identified and records of major equipment shall include: - - - - -
a. Name; - - - - -
b. Serial number or unique identification from name plate; - - - - -
c. Date received and placed in service; - - - - -
d. Current location; - - - - -
e. Condition at receipt; - - - - -
f. Manufacturer's instructions; - - - - -
g. Date of calibration or date of next calibration; - - - - -
h. Maintenance; - - - - -
i. History of malfunction. - - - - -
22 Maintenance. - - - - -
a. Documented evidence of routine preventive maintenance and calibration of equipment including, but not limited to: Thermometer, pipette, analytical balances, and additional analytical equipment. - - - - -
i. Calibration programs shall be established for key quantities or values of the instruments where these properties have a significant effect on the results. - - - - -
ii. Before being placed into service, equipment, including equipment used for sampling, shall be calibrated or checked to establish that it meets the laboratory's specification requirements and complies with the relevant standard specifications. - - - - -
iii. Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside of specified limits, shall be taken out of service. Such equipment shall be isolated to prevent its use or clearly labeled or marked as being out-of-service until it has been repaired and shown by calibration or test to perform correctly. - - - - -
b. Documentation of a maintenance schedule and reviewed by the laboratory director. - - - - -
i. Calibration procedures shall specify frequency of calibration checks. - - - - -
ii. Instruments that are routinely calibrated shall be verified daily or prior to analyzing samples (as applicable). - - - - -
iii. Acceptance criteria shall be determined, documented and used. - - - - -
iv. When possible, any external calibration service (metrological laboratory) used shall be a calibration laboratory accredited to ISO/IEC 17025:2005 by a recognized accreditation body. - - - - -
v. Laboratories shall demonstrate, when possible, that calibrations of critical equipment and hence the measurement results generated by that equipment, relevant to their scope of accreditation, are traceable to the SI through an unbroken chain of calibrations. - - - - -
vi. External calibration services shall, wherever possible, be obtained from providers accredited to one of the following: ISO/IEC 17025, ISO Guide 34, an ILAC recognized signatory, a CIPM recognized National Metrology Institute (NMI), or a state weights and measures facility that is part of the NIST laboratory metrology program. Calibration certificates shall be endorsed by a recognized accreditation body symbol or otherwise make reference to accredited status by a specific, recognized accreditation body, or contain endorsement by the NMI. Certificates shall indicate traceability to the SI or reference standard and include the measurement result with the associated uncertainty of measurement. - - - - -
vii. Where traceability to the SI is not technically possible or reasonable, the laboratory shall use certified reference materials provided by a competent supplier. - - - - -
viii. Calibrations performed in-house shall be documented in a manner that demonstrates traceability via an unbroken chain of calibrations regarding the reference standard/material used, allowing for an overall uncertainty to be estimated for the in-house calibration. - - - - -
ix. Calibrations shall be repeated at appropriate intervals, the length of which can be dependent on the uncertainty required, the frequency of use and verification, the manner of use, stability of the equipment, and risk of failure considerations. - - - - -
x. Periodic verifications shall be performed to demonstrate the continued validity of the calibration at specified intervals between calibrations. The frequency of verifications can be dependent on the uncertainty required, the frequency of use, the manner of use, stability of the equipment, and risk of failure considerations. - - - - -
c. Documentation of curative maintenance in logbook, signed and dated by laboratory director. - - - - -
d. Evidence of temperature monitoring for equipment requiring specific temperature ranges. - - - - -
e. Test and calibration equipment, including both hardware and software, shall be safeguarded from adjustments which would invalidate the test and/or calibration results. - - - - -
f. Decontamination and cleaning procedures for: - - - - -
i. Instruments; - - - - -
ii. Bench space; and - - - - -
iii. Ventilation hood/microbial hood. - - - - -
g. Documentation of adequacy of training of personnel and responsibility for each maintenance task. - - - - -
h. The organization shall describe or reference how periodic preventive and corrective maintenance of measurement or test equipment shall be performed to ensure availability and satisfactory performance of the systems. - - - - -
23 Computer systems (items verified upon on-site inspection). - - - - -
a. Adequate for sample tracking. - - - - -
b. Adequate for analytical equipment software. - - - - -
c. Software control requirements applicable to both commercial and laboratory developed software shall be developed, documented, and implemented. - - - - -
d. In addition, procedures for software control shall address the security systems for the protection of applicable software. - - - - -
e. For laboratory-developed software, a copy of the original program code shall be: - - - - -
i. Maintained; - - - - -
ii. All changes shall include a description of the change, authorization for the change; - - - - -
iii. Test data that validates the change. - - - - -
f. Software shall be acceptance tested when installed, after changes, and periodically during use, as appropriate. - - - - -
g. Software testing shall include performing manual calculations or checking against another software product that has been previously tested, or by analysis of standards. - - - - -
h. The version and manufacturer of the software shall be documented. - - - - -
i. Commercially available software may be accepted as supplied by the vendor. For vendor supplied instrument control/data analysis software, acceptance testing may be performed by the laboratory. - - - - -
24 Security. - - - - -
a. Written facility security procedures during operating and nonworking hours. - - - - -
b. Roles of personnel in security. - - - - -
c. SOP for controlled access areas and personnel who can access. - - - - -
25 Control of records. - - - - -
a. The laboratory shall establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. - - - - -
b. All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. - - - - -
c. Records must be retained for a period of three years. - - - - -
d. All records shall be held secure and in confidence. - - - - -
e. The laboratory shall have procedures to protect and back-up records stored electronically and to prevent unauthorized access to or amendment of these records. - - - - -
f. The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period. - - - - -
g. The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. - - - - -
h. The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results. - - - - -
i. Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task. - - - - -
j. When mistakes occur in records, each mistake shall be lined out, not erased or made illegible or deleted, and the correct value entered alongside. - - - - -
k. All such alterations or corrections to records shall be signed or initialed and dated by the person making the correction. - - - - -
l. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data. - - - - -
m. All entries to hard copy laboratory records shall be made using indelible ink. No correction fluid may be used on original laboratory data records. - - - - -
n. Laboratories shall establish and maintain a data review process beginning at sample receipt and extending through the report process. The data review process shall be an independent review, conducted by a qualified individual other than the analyst. - - - - -
o. The review process shall be documented before data are reported. - - - - -
26 Storage. - - - - -
a. Appropriate and adequate for sample storage over time. The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned. - - - - -
b. Adequate storage of chemical reference standards. - - - - -
c. Appropriate storage of any reagents: Fireproof cabinet, separate cabinet for storage of any acids. - - - - -
d. Appropriate safe and secure storage of documents etc., archiving, retrieval of, maintenance of and security of data for a period of three years. - - - - -
QA PROGRAM AND TESTING Document
Reference
Y N NA Comments
27 Sampling/sample protocols must be consistent with chapter 314-55 WAC, written and approved by the laboratory director, and must include documented training. - - - - -
a. Demonstrate adequacy of the chain-of-custody, including: Tracking upon receipt of sample including all personnel handling the sample and documenting condition of the sample through a macroscopic and foreign matter inspection. - - - - -
b. Macroscopic and foreign matter inspection - Fit for purpose test. Scientifically valid testing methodology: Either AHP monograph compliant or other third-party validation. - - - - -
c. Failed inspection of product: Tracking and reporting. - - - - -
d. Return of failed product documentation and tracking. - - - - -
e. Disposal of used/unused samples documentation. - - - - -
f. Sample preparation, extraction and dilution SOP. - - - - -
g. Demonstration of recovery for samples in various matrices (SOPs): - - - - -
i. Plant material - Flower; - - - - -
ii. Edibles (solid and liquid meant to be consumed orally); - - - - -
iii. Topical; - - - - -
iv. Concentrates. - - - - -
28 Data protocols. - - - - -
a. Calculations for quantification of cannabinoid content in various matrices - SOPs. - - - - -
b. Determination of the range for reporting the quantity (LOD/LOQ) data review or generation. - - - - -
c. Reporting of data: Certificates of analysis (CA) - Clear and standardized format for consumer reporting. - - - - -
d. Each test report shall include at least the following information, unless the laboratory has valid reasons for not doing so: - - - - -
i. A title (e.g., "Test Report" or "Certificate of Analysis"); - - - - -
ii. The name and address of the laboratory, and the location where the tests were carried out, if different from the address of the laboratory; - - - - -
iii. Unique identification of the test report certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate; - - - - -
iv. The name and address of the customer; - - - - -
v. Identification of the method used; - - - - -
vi. A description of, the condition of, and unambiguous identification of the item(s) tested; - - - - -
vii. The date of receipt of the test item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration; - - - - -
viii. Reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results; - - - - -
ix. The test results with, where appropriate, the units of measurement; - - - - -
x. The name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or certificate; and - - - - -
xi. Where relevant, a statement to the effect that the results relate only to the items tested or calibrated. - - - - -
e. Material amendments to a test report or calibration certificate after issue shall be made only in the form of a further document, or data transfer, which includes the statement: "Supplement to Test Report (or Calibration Certificate), serial number... (or as otherwise identified)," or an equivalent form of wording. - - - - -
f. When it is necessary to issue a complete new test report or calibration certificate, this shall be uniquely identified and shall contain a reference to the original that it replaces. - - - - -
g. If the laboratory chooses to include a reference to their I-502 certification on their test report, any test results not covered under I-502 certification shall be clearly identified on the report. - - - - -
h. Documentation that the value reported in the CA is within the range and limitations of the analytical method. - - - - -
i. Documentation that qualitative results (those below the LOQ but above the LOD) are reported as "trace," or with a nonspecific (numerical) designation. - - - - -
j. Documentation that the methodology has the specificity for the degree of quantitation reported. Final reports are not quantitative to any tenths or hundredths of a percent. - - - - -
k. Use of appropriate "controls": Documentation of daily use of positive and negative controls that challenge the linearity of the curve; and/or an appropriate "matrix blank" and control with documentation of the performance for each calibration run. - - - - -
29 Chemical assay procedure/methodology. - - - - -
30 Quality Control (QC): - - - - -
a. Documentation of use of an appropriate internal standard for any quantitative measurements as applicable to the method. - - - - -
b. Appropriate reference standards for quantification of analytes, performing and documenting a calibration curve with each analysis. - - - - -
i. Reference materials shall, where possible, be traceable to SI units of measurement, or to certified reference materials. Internal reference materials shall be checked for accuracy as far as is technically and economically practicable. - - - - -
ii. The laboratory shall create and follow procedures for safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity. - - - - -
iii. Reference materials shall have a certificate of analysis that documents traceability to a primary standard or certified reference material and associated uncertainty, when possible. When applicable, the certificate must document the specific NIST SRM® or NMI certified reference material used for traceability. - - - - -
c. Demonstration of calibration curve r2value of no less than 0.995 with a minimum of four points which bracket the expected sample concentration range. - - - - -
i. The calibration curve shall be verified by preparing an independently prepared calibration standard (from neat materials) or with a standard from an independent source. Acceptance criteria for the standard calibration curve and the independent calibration verification standard shall be documented. - - - - -
ii. Instrument calibration/standardization shall be verified each 24-hour period of use, or at each instrument start-up if the instrument is restarted during the 24-hour period, by analysis of a continuing calibration verification standard. Acceptance criteria shall be documented. - - - - -
iii. Calibration or working quantification ranges shall encompass the concentrations reported by the laboratory. Continuing calibration verification standards and continuing calibration blanks shall be analyzed in accordance with the specified test methods. Acceptance criteria shall be documented. - - - - -
d. Assuring the quality of test results. - - - - -
i. The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. - - - - -
ii. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. - - - - -
iii. This monitoring shall be planned and reviewed and may include, but not be limited to, the following: - - - - -
A. Regular use of certified reference materials and/or internal quality control using secondary reference materials; - - - - -
B. Participation in interlaboratory comparison or proficiency-testing programs; - - - - -
C. Replicate tests or calibrations using the same or different methods; - - - - -
D. Retesting or recalibration of retained items; - - - - -
E. Correlation of results for different characteristics of an item. - - - - -
iv. Quality control data shall be analyzed and, where they are found to be outside predefined criteria, planned actions shall be taken to correct the problem and to prevent incorrect results from occurring. - - - - -
v. The laboratory shall determine, where feasible, the accuracy and precision of all analyses performed. - - - - -
vi. Acceptance limits for each method shall be established based on statistical evaluation of the data generated by the analysis of quality control check samples, unless specific acceptance limits are established by the method. - - - - -
vii. Control charts or quality control data bases shall be used to record quality control data and compare them with acceptance limits. - - - - -
viii. Procedures shall be used to monitor trends and the validity of test results. - - - - -
31 Proficiency. - - - - -
a. Participation in approved PT programs for each field of testing. - - - - -
b. Passing PT results for two consecutive PTs. - - - - -
c. Documentation of investigation for all failed PTs. - - - - -
32 Method validation: Scientifically valid testing methodology: AHP monograph compliant, other third-party validation or the current version of a standard method. The following requirements are applied to other third-party validation: - - - - -
a. The laboratory shall validate nonstandard methods, laboratory-designed/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use. - - - - -
b. The validation shall be as extensive as is necessary to meet the needs of a given application or field of application. - - - - -
c. The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use. - - - - -
d. The customer shall be informed as to the method chosen. - - - - -
e. The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations. If the standard method changes, the confirmation shall be repeated. - - - - -
f. Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer. - - - - -
g. Validation shall be documented and include the following elements as applicable: - - - - -
i. Minimum acceptance criteria; - - - - -
ii. Analyte specificity; - - - - -
iii. Linearity; - - - - -
iv. Range; - - - - -
v. Accuracy; - - - - -
vi. Precision; - - - - -
vii. Detection limit; - - - - -
viii. Quantification limit; - - - - -
ix. Stability of samples and reagents interlaboratory precision; - - - - -
x. Analysis robustness; - - - - -
xi. Presence of QC samples; - - - - -
xii. Use of appropriate internal reference standard; - - - - -
xiii. Daily monitoring of the response of the instrument; - - - - -
h. Validation shall be performed for matrix extensions for each type of product tested, including data review of recovery for: - - - - -
i. Solvent-based extract; - - - - -
ii. CO2 extraction or other "hash oil"; - - - - -
iii. Extract made with food grade ethanol; - - - - -
iv. Extract made with food grade glycerin or propylene glycol; - - - - -
v. Infused liquids; - - - - -
vi. Infused solids; - - - - -
vii. Infused topical preparations; - - - - -
viii. Other oils, butter or fats. - - - - -
33 Estimation of uncertainty of measurement. - - - - -
a. Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement. The laboratory shall at least attempt to identify all the components of uncertainty and make a reasonable estimation, and shall ensure that the form of reporting of the result does not give a wrong impression of the uncertainty. Reasonable estimation shall be based on knowledge of the performance of the method and on the measurement scope and shall make use of, for example, previous experience and validation data. - - - - -
b. In those cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is considered to have satisfied this clause by following the test method and reporting instructions. - - - - -
c. When estimating the uncertainty of measurement, all uncertainty components which are of importance in the given situation shall be taken into account using appropriate methods of analysis. - - - - -
d. Sources contributing to the uncertainty include, but are not necessarily limited to, the reference standards and reference materials used, methods and equipment used, environmental conditions, properties and condition of the item being tested or calibrated, and the operator. - - - - -
e. Test methods are classified as either qualitative or quantitative. Qualitative tests are defined as having nonnumerical results. Although estimation of measurement uncertainty is not needed for these tests, laboratories are expected to have an understanding of the contributors to variability of the results. For quantitative tests, laboratories shall determine measurement uncertainty using appropriate statistical techniques. - - - - -
f. Laboratories shall make independent estimations of uncertainty for tests performed on samples with significantly different matrices. - - - - -
g. Laboratories are required to re-estimate measurement uncertainty when changes to their operations are made that may affect sources of uncertainty. - - - - -
h. When reporting measurement uncertainty, the test report shall include the coverage factor and confidence level used in the estimations (typically k = approximately 2 at the 95% confidence level). - - - - -
34 Other methods. - - - - -
a. Validated microbiological methods fit for purpose. - - - - -
b. Microbial contaminants within limits as directed by WSLCB. - - - - -
c. Moisture content testing fit for purpose. Scientifically valid testing methodology: AHP monograph compliant, or other third-party validation. - - - - -
d. Solvent residuals testing fit for purpose; solvent extracted products made with class 3 or other solvents used are not to exceed 500 parts per million (PPM) per one gram of solvent based product and are to be tested. - - - - -
e. Any other QA/QC methods is proven to be fit for purpose. - - - - -
35 Laboratory records. - - - - -
a. Legible and in ink (or computerized system). - - - - -
b. Signed and dated. - - - - -
c. Changes initialed and dated. - - - - -
d. Evidence of periodic review and signed by a management representative. - - - - -
36 Preventive/corrective action. - - - - -
-The laboratory shall establish a policy and procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations are identified. - - - -
a. The procedure for corrective action shall start with an investigation to determine the root cause(s) of the problem. - - - - -
b. Where corrective action is needed, the laboratory shall identify potential corrective actions. It shall select and implement the action(s) most likely to eliminate the problem and to prevent recurrence. - - - - -
c. The laboratory shall document and implement any required changes resulting from corrective action investigations. - - - - -
d. Any PT round that leads to the nonproficient status of a laboratory shall be addressed by the corrective action process. - - - - -
e. The laboratory shall monitor the results to ensure that the corrective actions taken have been effective. - - - - -
f. When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement. - - - - -
37 Complaints. - - - - -
a. The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. - - - - -
b. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory. - - - - -
c. Test reports. - - - - -
d. Each test report or calibration certificate shall include at least the following information, unless otherwise justified: - - - - -
i. A title (e.g., "Test Report" or "Calibration Certificate"); - - - - -
ii. The name and address of the laboratory, and the location where the tests and/or calibrations were carried out, if different from the address of the laboratory; - - - - -
iii. Unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate; - - - - -
iv. The name and address of the customer; - - - - -
v. Identification of the method used; - - - - -
vi. A description of, the condition of, and unambiguous identification of the item(s) tested or calibrated; - - - - -
vii. The date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration; - - - - -
viii. Reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results; - - - - -
ix. The test or calibration results with, where appropriate, the units of measurement; - - - - -
x. The name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate; and - - - - -
xi. Where relevant, a statement to the effect that the results relate only to the items tested or calibrated. - - - - -
38 Periodic management review and internal audit. - - - - -
a. Laboratory management shall annually review its quality system and associated procedures to evaluate continued adequacy. This review shall be documented. - - - - -
b. Periodically and in accordance with a predetermined schedule perform an internal audit of laboratory operations to verify compliance to the GLP checklist. - - - - -