ICH Q7 – GMPs for Active Pharmaceutical Ingredients
Duration : 90 Minutes
John E. Lincoln,
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assuranc Read more
ICH Q7 is an international 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 Q7 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 these.
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.
Course Outline:
• The Basis QMS – ISO 9001 (“13485”)
• The ICH Q7 API GMP specifics
• Systems, Personnel, 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Senior management in Pharma, Combination Products
• Pharma development and 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
