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There seems to be as many interpretations of Product Specification File (PSF) requirements as there are the number of sites that we have visited.

As contract QPs for Investigational Medicinal Products (IMPs) we have visited a number of manufacturing sites, either as a contract QP, or on audit duty on behalf of a sponsor or manufacturer.

Why are there so many variations of the PSF?

Why do so many people think that this is the QP’s file?

Is this your Project Management file?

PSFThe product reference section of the PSF can be used to demonstrate precisely (to both regulators and clients) the product level specifics that have been put in place to control your products.  Many sites do not use the PSF to its full potential: as a file that can be used to project manage drug product manufacture as well as a file that the QP references during QP certification.  Other companies have invented their own documents which fulfil the product specific details of the PSF.
For us, the PSF should contain a reference section for the source information to demonstrate product control.  This section is set up to detail the product specific decisions made by the sponsor and manufacturer.  It is aligned with the IMPD but has more specific information.  When designed and approved appropriately it contains the source information for both technical review and QA approval of manufacturing documents, throughout the manufacturing life cycle.

Annex 13 EU GMP states that the PSF is “a reference file containing, or referring to files containing, all the information necessary to draft the detailed written instructions on processing, packaging, quality control testing, batch release and shipping of an investigational medicinal product.”  It then goes on to provide a detailed list of the PSF contents.  Why then are there so many variations of the PSF?

Call us for information on how we can help you design your product reference file templates to ensure you have everything covered, whether for your Investigational or Commercial Product.