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Medicinal cannabis manufacture

Technical guidance on the interpretation of the PIC/S Guide to GMP

10 December 2019

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Documentation (Chapter 4, Part I - finished dosage form)

Specifications

The TGA will not evaluate the raw material and finished product specifications for unapproved medicinal cannabis products to ensure these comply with the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order.

The manufacturer is required to review their raw material and finished product specifications against the requirements of TGO 93. If you are satisfied that your unapproved medicinal cannabis product(s) meet the requirements of the standard, you should complete the declaration form available on the TGA website to declare that your medicinal cannabis product(s) meets this standard. The TGA may ask for a representative certificate of analysis for review to ensure compliance with TGO93. Medicinal cannabis products, like all therapeutic goods may be subject to testing by the TGA to confirm compliance with applicable standards.

GMP inspectors will review the specifications and certificates of analysis as part of the GMP inspection to confirm you are meeting appropriate standards.

Retention of batch documents

Batch documents must be kept for at least one year after the expiry date or at least 5 years after release for supply by the authorised person, whichever is the longest. The batch documentation for investigational products must be kept for at least 5 years following completion or formal discontinuation of the last clinical trial. Other times of retention of batch documents may be required based on specific legislative requirements.

Authorised person access to records

As the Authorised Person for release for supply takes responsibility for releasing and placing batches of product on the market, it is important that they have appropriate access to any documents that facilitate or influence their decisions. Accordingly, systems should be implemented to facilitate an authorised person's access to all documentation relevant to a specific batch, including, but not limited to, validation documents, stability data, test results and batch records.

Guidance as to the minimum documentation required to be held by authorised persons performing release for supply of products manufactured under contract may be found in the TGA guidance on Release for supply of medicines.

Batch numbers in distribution records

Distribution records require batch numbers (clause 4.28). According to clause 8.13 the recording of batch numbers in distribution records is mandatory.

Signature list

Manufacturers need to maintain a signature list. These should include the names, signatures and initials used by individuals who complete GMP documentation. The signature list is the key reference when providing traceability between manual signatures used on documents and the individuals who completed them.

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