Typische GMP-Defizite bei Herstellern von chemischen Wirkstoffen

The presence of foreign particles (sometimes also referred to as: visible particles, insoluble particles/matter) in APIs or Excipients represents a topic of increasing interest and concern of regulators and customers. Although to some extent technically unavoidable, this is caused by the fact, that analytical methods for the detection have been constantly improved but at the same time the guidance from Pharmacopoeias (e.g. EP, USP) or health authorities (e.g. EMA, FDA) about particles is very limited: certain drug products are expected to be “essentially free from visible particles” (USP <790>) or “practically free from particles” (Ph. Eur. 2.9.20.).

In this situation, two actual Guidance documents from industry organizations, one published by the Active Pharmaceutical Ingredients Committee (APIC) for APIs and the other published by the International Pharmaceutical Excipients Council (IPEC) for Excipients, provide helpful insights and support. Considering the ICH Q9 guideline, thereby the risk associated with (foreign) particles from APIs or Excipients in drug products may be more easily understood and can thus be adequately managed.

The APIC guide consists of the following chapters:

  • Chapter 1: Acknowledgements
  • Chapter 2: Introduction and Purpose
  • Chapter 3: Scope
  • Chapter 4: Definitions of Particles
  • Chapter 5: Good Practices to minimize the presence of Particles in APIs
  • Chapter 6: Analytical Controls and Acceptance Criteria
  • Chapter 7: Incident Management
  • Chapter 8: References
  • Chapter 9: Glossary

The IPEC guide consists of the following chapters:

  • Chapter 1: Background and Purpose
  • Chapter 2: Scope
  • Chapter 3: General Principles
  • Chapter 4: General Concepts
  • Chapter 5: Risk Assessment
  • Chapter 6: Technically Unavoidable Particle Profile
  • Chapter 7: Atypical Particles
  • Chapter 8: Expectations of Excipients Manufacturers
  • Chapter 9: User Evaluation Criteria

EudraGMDP Database: French Manufacturer of Alginic Acid listed as EU GMP part II non-compliant

Based upon an inspection carried out end of July by the French National Agency for Medicines and Health Products Safety (ANSM) for the API Alginic Acid at a site in France, the manufacturer was assessed not to comply with the EU GMP part II principles.

Major GxP Events IV/2015