GMP Compliance – Biologicals and ATMP Manufacturing
“The holder of a manufacturing authorization must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization (MA) and do not place patients at risk due to inadequate safety, quality or efficacy”. (Quote EurdraLex Vol 4)
What is GMP Compliance?
Compliance with Good Manufacturing Practice (GMP) states that medicinal products must be manufactured under specified quality standards to ensure the product’s safety, efficacy and quality.
Why is GMP compliance mandatory?
Medicinal products are intended to cure, relieve or prevent diseases, but they also have the potential to be unsafe or harmful.
Compliance with GMP verifies that the product, the manufacturing process, the manufacturing facilities and the manufacturing environment (e.g. documentation, sanitation, personal, etc.) meet applicable quality standards.
FDA Statutory and Regulatory GMP Requirements
Federal Food, Drug, and Cosmetic Act (FDC Act)
The regulatory basis for Good Manufacturing Practice (GMP) is the Federal Food, Drug, and Cosmetic Act (FDC Act). The GMP requirements are codified by the FDA of the Code of Federal Regulations (CFR) Title 21 Food and Drugs parts 210 and 211:
CFR Title 21 Part 211 – Current good manufacturing practice for finished pharmaceuticals
Risk Assessment and Lifecycle Management
Manufacturers of biotechnological-derived medicinal products are required to follow risk-based approaches in their GMP compliance operations. The GMP Guidelines states that a quality risk approach should be applied throughout the product and process lifecycle.
The assessment shall follow the impact of potential risks in terms of quality, safety and efficacy of the product as well as other risks to health, human and environment and implement control and mitigation activities to minimize all the potential risks where possible.
The evaluation of the risk assessment should be knowledge-based on current scientific knowledge and the accumulated experience during drug development, preclinical development, quality control and manufacturing processes.
Biologics License Applications (BLA)
Biological products subject to the PHS Act are licensed under the section 351 of the PHS Act. The regulatory requirement for the BLA is defined in Code of Federal Regulations CFR Title 21 Part 601 Licensing.
A potency assay is required due to the complexity and heterogeneity of biotechnological-derived medicinal products.
Implement International GMP Regulations
German Regulatory Requirements
Key Benefits
Our validation engineers have the ability to interpret international GMP regulations and requirements and apply them accordingly to your qualification activities and validation studies.
