Laboratory Analysis

 

Why Laboratory Analysis

Lab testing provides a more scientific process of identifying why some strains are better at treating certain symptoms than others. Consistent, measurable standards for medicines offered will only help the industry legitimize itself and be better prepared when regulations are put forward.


Potency analysis..

 measures the percentage of THC, CBD, and CBN.
Patients deserve to choose how strong a product in each of these categories they require. Dispensaries and caregivers need to know what ratio and strengths to offer their patients for their symptoms. Potency quantification provides the percentages of three major cannabinoids: THC, CBD and CBN. Growers need to know how their strains are testing and if their cloning efforts are paying off. The Haven Center needs to Know what we grow and know what medicinal value we are delivering to our patiants.

Testing provides ...

percentages of THC, the psychoactive component of cannabis as well as CBD (pain relief) and CBN (nausea relief). Haven Center testing will include both safety screening and potency analysis.

Safety screening...

 analyzes and detects contamination of pathogenic molds, which can threaten the health of patients with compromised immune systems.

The Haven Center will post labels in display cases,also affixed to the products themselves. Labels will include % for CBN, THC, CBD and safty information.

QUALITY CONTROL PLAN SUMMARY

The Quality Control and Recall Plan outlines RMD procedures for quality control that will ensure the production and processing of marijuana is in full compliance with Department regulations and mandatory testing requirements. The provisions contained herein are established to ensure all marijuana produced by The Haven Center is tested for contaminants and cannabinoid profile in compliance with testing guidelines published by the Department, and to ensure that the results of all testing are maintained for no less than one year. A contractual arrangement for testing services will be maintained by The Haven Center at all times, with an appropriately accredited laboratory approved by the Department.

It is established here that all marijuana will be processed in a safe and sanitary manner. Only the leaves and flowers of a female marijuana plant will be processed and will be well cured, free of seeds, stems, dirt, sand, debris and other foreign matter; free of contamination by mold, rot, other fungus and bacterial diseases; prepared and handled on food-grade stainless steel tables; and packaged in a secure area.

Procedures for handling voluntary and mandatory recalls of marijuana are included with procedures for addressing customer complaints and incidents requiring product withdrawals. Incident classification terms are defined with distinct mitigation procedures, as the term “recall” can have legal significance, insurance and liability implications. The term “recall” will be used carefully and only when regulations mandate. Examples of incidents to be addressed with recall or withdrawal procedures are provided, and measures for required mock withdrawal and recall drills are detailed. Provisions include plans for the establishment of a Recall Management Team, which will be responsible for product traceability and for coordinating all aspects of a withdrawal or product recall. A Recall Management Team contact sheet is included here and will be maintained and updated by the general manager. Sample forms from the Complaint Log and the Withdrawal and Recall Log component of the Incident Log are included. In the instance of a Recall, the Department will be notified within 24 hours.


QUALITY ASSURANCE

Marijuana processing.
All marijuana must be processed in a safe and sanitary manner. Only the leaves and flowers of a female marijuana may be processed and must be:
1. Well cured and free of seeds and stems;
2. Free of dirt, sand, debris and other foreign matter;
3. Free of contamination by mold, rot, other fungus, and bacterial diseases;
4. Prepared and handled on food-grade stainless steel tables; and
5. Packaged in a secure area.
105 CMR 725.105(C)(4).


PRODUCT TESTING

Compliance with Department testing directives.
It is the policy of The Haven Center to comply with all Department testing guidance, including but not limited to:
1. Approved laboratories;
2. Frequency required;
3. Contamination response plans;
4. Lot size; and
5. Sample size.
105 CMR 725.105(C)(2).

Required testing.
All marijuana cultivated by The Haven Center must be tested. Mandatory testing includes:
1. Cannabinoid profile, and
2. Contaminant presence (to be determined by the Department) including, but not limited to:
a. Mold;
b. Mildew;
c. Heavy metals;
d. Plant growth regulators; and
e. Non-organic pesticides.
105 CMR 725.105(C)(2)(a).

Additional testing may be required.
The Department may require additional testing. The Haven Center must comply with all published Department testing requirements. 105 CMR 725.105(C)(2)(a).


Laboratory contract required.

The Haven Center must maintain a contractual arrangement for testing services at all times including a clause that requires the persons responsible for testing be registered with the Department as a dispensary agent.
All contractual services must be provided by a laboratory that is:
1. Accredited to International Organization for Standardization (ISO) 17025 by a third party accrediting body such as A2LA or ACLASS; or
2. Certified, registered, or accredited by an organization approved by the Department.
CMR 725.105(C)(2)(d); 105 CMR 725.105(C)(2)(f).

Sample transportation.
All marijuana transported to a laboratory for testing purposes will be done in accordance with the procedures in the Product Storage and Transportation Plan. 105 CMR 725.105(C)(2)(i).

Excess marijuana returned.
Any excess test material returned by a laboratory to The Haven Center must be handled in accordance with the procedures in the Inventory Management and Waste Disposal Plan. 105 CMR 725.105(C)(2)(k).

Recordkeeping.
All test results must be maintained for at least one year. 105 CMR 725.105(C)(2)(b).