Today we’re back with the next step in the Nine Gate Transfer Process for Moving Production from site to site. So far we’ve covered the first four gates, which you can review in our last blog post. Now, let’s discuss Gate 5: GMP Documentation.
Hundreds of GMP documents are required for process transfers. The Code of Federal Regulations provides a listing of expected documentation including:
- raw material and component documentation
- logbooks
- batch records
- laboratory records
- distribution records
A complete list can be developed utilizing the process maps (see Gate 4) and standard documentation sets. Once the list is made, divide the documents into groups. Remember raw materials documents will probably be required first, but finished product testing protocols often require finished goods test procedures to be validated prior to accepting the product. The project schedule should provide insight into when documents will be required.
The quickest way to complete the transfer is to reformat records from the sending site, but this practice often leads to non-conformances and issues because there is a lack of understanding content and history. Each document needs to be built with the foundation process map identified in Gate 4 and utilizing Subject Matter Experts (SME) identified as part of Gate 2. The control of the critical process parameters (CPP) must be understood and the control strategy needs to be included in the documentation to ensure product attributes are achieved.
Agreement on terminology and format with quality and regulatory units helps ensure standardized documentation, which allows employees to follow repeatable processes. Each document should have a dry run with personnel who have not been exposed to the process, the related SME and a documentation author (if necessary). Pictures often help, but authors need to be mindful of what is in the background. For example, I once had a formulation tank CIP procedure written with pictures taken in the tank manufacturer’s parking lot.
Finally a document review team is formed with appropriate representation to ensure content is consistent with expectations. Often document reviewers lack the process understanding to assess technical details but can provide oversight for other requirements. The documentation tracking sheet should monitor status and escalation needs to occur if a maximum of two revision cycles is not achieved.
Continue the process with Gate 6: Formulation and Process Development.
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