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Setting up a Microbiology Lab and getting cannabis GMP certification

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Guest user Created:   Dec 11, 2020 Last commented:   Dec 15, 2020

Setting up a Microbiology Lab and getting cannabis GMP certification

Is it possible to get GMP certification on cannabis testing within a laboratory without having GMP certification in the Microbiology dept.

If not, then if the laboratory is ISO 17025 accredited, then presumably we will have to get GMP accreditation first for the Microlab and then for cannabis testing, or can we combine the two?

Can you give a brief overview of what we need to do to achieve this?

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Dec 15, 2020

You asked

"Is it possible to get GMP certification on cannabis testing within a laboratory without having GMP certification in the Microbiology dept.

GMP is Good Manufacturing Practice (GMP) and relates to the production and control of products (and facilities) through quality standards. Typically in larger companies, the company / production facility will be GMP certified, not the quality control / testing Laboratory. This does, of course, depend  on the company structure (the company and laboratory may be the same entity).  As the company must maintain reliable testing laboratories, this means all quality aspects, including the quality control microbiology laboratory; must be GMP compliant. The laboratory  functions as an inhouse testing facility so must comply with the requirements of GMP, as relates to what it does.

You also asked

If not, then if the laboratory is ISO 17025 accredited, then presumably we will have to get GMP accreditation first for the Microlab and then for cannabis testing, or can we combine the two?

Regulations vary greatly with Cannabis products – some countries / States require testing laboratories to be ISO 17025 accredited. GMP is more commonly a compliance requirement.  Yes, you can certainly combine the GMP and ISO 17025 implementation. I would suggest you start by developing a ISO 17025 implementation / GMP compliance plan and incorporate accreditation for the laboratories as part of that plan. Identify and address all the laboratory requirements and expand and documentation and requirements to meet GMP as well.

It will depend on your customer and regulatory needs whether you apply for ISO 17025 accreditation or GMP certification first. Have a look at the following articles for further overview of ISO 17025 The Toolkit may be a suitable start .

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Dec 11, 2020

Dec 15, 2020