As processes may not be standardized or fully validated, end-product testing is more important in ensuring that each batch meets its specification.
Product release is often carried out in two stages, before and after final packaging:1
1. Bulk product assessment: this should cover all relevant factors, including production conditions, the results of in-process testing, a review of manufacturing documentation and compliance with the product specification file and the order.
2. Finished product assessment: this should cover, in addition to the bulk product assessment, all relevant factors, including packaging conditions, the results of in-process testing, a review of packaging documentation and compliance with the product specification file and the order.
1 This practice also exists at certain large companies with regard to licensed products.
When necessary, quality control should also be used to verify the similarity in appearance and other physical characteristics, odour, and taste of "blinded" investigational products.
Samples of each batch of product should be retained in the primary container used for the study or in a suitable bulk container for at least 2 years after the termination or completion of the relevant clinical trial. If the sample is not stored in the pack used for the study, stability data should be available to justify the shelf-life in the pack used.