Documentation

In general, processing records for routine production batches should provide a complete account of the manufacturing process for each batch of biological product that demonstrates that it was produced, tested, and dispensed in accordance with approved procedures. In the case of vaccines, a batch processing record and a summary protocol should be prepared for each batch intended for lot release by the NRA. Information included in the summary protocol should follow WHO guidelines for independent lot release by regulatory authorities (36). The summary protocol and all related records must be of a type approved by the NRA.

Manufacturing batch records should be retained for at least 1 year after the expiration date of the biological product batch and should be readily retrievable for inspection by the NRA. It has been found that documents kept for long periods of time can provide useful information regarding AEFI and other investigations.

Additional documentation on the source of starting materials, origin, supply chain, methods of production and controls applied may be required to ensure an appropriate level of control, including microbiological quality, if applicable.

Some product types may require a specific definition of which components constitute a batch – particularly somatic cells in the context of ATMPs. For autologous and donor-matched situations, the manufactured product should be viewed as a batch.

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