Manufacture of Biological Active Substances and Medicinal Products for Human Use
Provides GMP requirements specific to biological active substances and medicinal products, covering cell banking, seed lot systems, containment of adventitious agents, and the additional controls required for biological processes.
Manufacturers of biological active substances and biological medicinal products including vaccines, monoclonal antibodies, and plasma-derived products. Advanced therapy medicinal products (ATMPs) are excluded — they are covered by the dedicated Part IV ATMP GMP guideline.
- 01Two-tier cell banking system with full characterisation of master cell bank (MCB) and working cell bank (WCB)
- 02Adventitious agent testing programme covering viral, mycoplasma, and bacteriophage contamination
- 03Segregation and containment strategies for organisms with different containment requirements
- 04Seed lot systems for fermentation/culture processes
- 05Closed process design where possible; containment strategy for open steps
Current version came into operation 31 January 2013 (restructured GMP guide; broader biological product scope). ATMPs were subsequently carved out to the standalone Part IV ATMP GMP guideline.
EU GMP Annex 2: frequently asked questions
Quick answers to common questions about EU GMP Annex 2.
What is EU GMP Annex 2?
EU GMP Annex 2 — Manufacture of Biological Active Substances and Medicinal Products for Human Use — is a regulation issued by the European Medicines Agency (European Union). Provides GMP requirements specific to biological active substances and medicinal products, covering cell banking, seed lot systems, containment of adventitious agents, and the additional controls required for biological processes.
Who does EU GMP Annex 2 apply to?
Manufacturers of biological active substances and biological medicinal products including vaccines, monoclonal antibodies, and plasma-derived products. Advanced therapy medicinal products (ATMPs) are excluded — they are covered by the dedicated Part IV ATMP GMP guideline.
What are the key requirements of EU GMP Annex 2?
EMA EU GMP Annex 2 requires, among other things: Two-tier cell banking system with full characterisation of master cell bank (MCB) and working cell bank (WCB); Adventitious agent testing programme covering viral, mycoplasma, and bacteriophage contamination; Segregation and containment strategies for organisms with different containment requirements; Seed lot systems for fermentation/culture processes.
When was EU GMP Annex 2 last updated?
The current version of EU GMP Annex 2 dates from January 2013. Current version came into operation 31 January 2013 (restructured GMP guide; broader biological product scope). ATMPs were subsequently carved out to the standalone Part IV ATMP GMP guideline.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When EU GMP Annex 2 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.