ICH Q7 – GMPs for Active Pharmaceutical Ingredients

ICH Q7 is an internatioinal guidance document for recommended Good Manufacturing Practices for APIs. Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this guidance. This webinar discusses the key parts of ICH Qy that applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile.

The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidances for drug (medicinal) products as defined by local authorities. This guidance covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, recovery from natural sources, or any combination of thes

Why You Should Attend:

This webinar is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.

Areas Covered in the Session :

• The Basis QMS  – ISO 9001 (“13485”)
• The ICH Q7 API GMP specifics 
• Systems, Personell, the Physical Plant 
• If it isn’t documented, it didn’t Happen
• Control of material, product, manufacturing 
• Laboratory Controls
• Validations
• Material / product rejection, release
• Complaint handling and other post-production issues

Who Should Attend:

• Senior management in Pharma, Combination Products
• Pharma development and testing testing teams
• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Validation Departments
• Marketing Departments
• Documentation Departments