Update of the "ICH Q7 Side-by-Side Comparison" Booklet
The newly published booklet "ICH Q7 Side-by-Side Comparison" compares the requirements of the "ICH Q7 Guideline- GMP for Active Pharmaceutical Ingredients" to the interpretations of the revised "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" (Version 16) and explains the requirements of the guideline.
At the end of October 2022, APIC, a sector group of the European Chemical Industry Council (CEFIC), published the 16th version of the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients. The main additions and updates were made to the following chapters:
- (1) Introduction
- (6) Documentation and Records
- (10) Storage and Distribution
- (12) Validation
All participants of the ICH Q7 Training Courses, which will be held November 21-25, 2022, will receive a free copy of the "ICH Q7 Side-by-Side Comparison" booklet. For more information on the full event agenda, please visit the ICH Q7 Week website.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others