GMP Compliance Consulting – Biological and ATMP Manufcaturing
About 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.
Compliance with GMP is mandatory for all medicinal products to receive the manufacturing authorization and applies over the product lifecycle.
We are contributing to regulatory requirements for GMP release of samples according to customer’s needs.
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
Why do we need GMP regulation?
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 requirements to ensure the continued safety, purity and potency over the product’s life cycle.
FDA Regulations for Biological Products
License Application
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.
The requirements are that the product, the manufacturing process, and the manufacturing facilities meet applicable quality standards to ensure the continued safety, purity and potency of the product.
A potency assay is required due to the complexity and heterogeneity of biotechnological-derived medicinal products.
Regulatory GMP Requirements
German Regulatory Requirements
Our validation engineers, who are well-qualified, have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to biopharmaceuticals and immunotherapies, allowing us to contribute GMP expertise and compliance consulting to your equipment qualification and system validation.