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

FDB3785

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance