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PE009-13, the PIC/S guide to GMP for medicinal products
TGA interpretation and expectations for demonstrating compliance
Documentation (Chapter 4)
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.
Documents used to record the manufacture of radiopharmaceuticals should be stored for a minimum of 3 years.
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, batch records, etc.
Guidance as to the minimum documentation requirements required to be held by Authorised Persons performing release for supply of products manufactured under contract may be found in the Guidance on Release for Supply.
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.
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.