16GMP Supporting Documents Clause Samples
The '16GMP Supporting Documents' clause requires the provision and maintenance of documentation that substantiates compliance with Good Manufacturing Practices (GMP). This typically involves supplying records such as batch production logs, quality control reports, and certificates of analysis to demonstrate that products are manufactured according to regulatory standards. By mandating these supporting documents, the clause ensures transparency and accountability in manufacturing processes, helping to verify product quality and regulatory compliance.
16GMP Supporting Documents. GMP Supporting Documents shall mean the documents referenced in the GMP Amendment as the basis for establishing the GMP. The GMP Supporting Documents shall expressly identify the Plans and Specifications, assumptions, qualifications, exclusions, conditions, allowances, unit prices, and alternates that form the basis for the GMP.