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Description, documentation, and result of the validation studies should be provided from critical steps or critical assays used in the manufacturing process (e.g. List of biological starting materials (human or animal origin) with information on the provisions to avoid risk of Transmissible Spongiform Encephalopathies (TSEs) and human diseases (HIV, hepatitis, etc) in the final product; give tests and specifications by supplier and repeated by QC.
Certificates for bovine and human derived products used in production indicating the supplier, source, supplier tests for risk contaminants and results should be provided.
For non-functional secondary packaging components (e.g. those that do not provide additional protection nor serve to deliver the product), only a brief description should be provided.