In House Training Course
ICH Q7 / Part II EU GMP Guide
Essential GMP Guide for APIs
For Pharmaceutical, Biopharmaceutical and Allied Industries
Regulatory Requirements, Guidelines and Practical Approaches to Manufacturing APIs
DAY ONE
Basic Requirements of ICH Q7 Guideline (EU GMP Guidelines, Part II)
Regulatory Relevance
- New GMP requirement for ICHQ7
- FDA draft guidance
- The Role of API inspection and Enforcement
ICHQ7 legal basis
- Legal status in EU and U.S
- Political and Legislation Issues Affecting APIs
Managing Quality
- Setting up Quality Units
- Responsibilities
- Verification of Compliance via Self Inspection
- Regular Quality Review to verify consistency
Individual Functions and Qualifications
- Training
- Hygiene
- Using a Consultant
Facilities and Maintenance
- Building Design and Construction
- Utilities
- Containment
- Refuse
- Cleaning Schedules
Process Maintenance
- Calibration
- Equipment Maintenance
- Design and Cleaning
Recording and Documentation
- Master Production
- Specifications and Documentation Systems
- Batch Record and Review
WORKSHOP: ICH Impact on Contract Manufacturers, Brokers, Distributors and Agents - Applicability
- Traceability of Distributed API and Intermediate
- Quality Management and Repackaging
- Transfer of Information
- Handling of Complaints, Recalls and Returns
Handling Regulatory Changes and Deviations
- Modifications in U.S
- Differences in the EU and FDA perspective Ensuring Compliance
Questions and Answers
DAY TWO
Incoming Materials
- Sampling, Testing and Quarantine
- Correct Storage
- Packaging
Packaging and Distribution
- Process Materials
- Labeling Issues
- Packaging Validation
Laboratory Controls
- Testing of Intermediates and API’s
- Validating and Certification of Analytical Procedures
- Stability Monitoring
- Reserve Sample and Retesting
Validation and Change control
- Cleaning Validation
- Process Validation Program
- Validation Reports Cross- Referencing Validation Protocols
- Qualification of Critical Equipment and Ancillary Systems
- Validation of Analytical Methods
Complaints, Returns and Recalls
- Constant Review Control of Returns
- Rejection /Recovery
- Reprocessing and Reworking
Case study : Handling Manufacturing Deviations
Preparation for Audits of APIs against ICH Requirements
- How to Audit Manufacturers and Suppliers
- Key issues during restricted audits
- Counterfeit API Issues with agents / distributers etc.
WORKSHOP (Chapter 18):General Differences between Chemical and Biotechnology Production Process
- API’s manufactured by Cell Culture(&)/ Fermentation vs. API’s manufactured by Chemical Synthesis
- General differences in equipment and facilities for the biotech and chemical technology according to ICHQ7
ICH Q7 Chapter 19 APIs for Use in Clinical Trials
- Differences in control requirements
- Impact on IMP regulations
Open Forum – Questions and Answers
Summary:
- Requirements and guidelines
- GMP considerations tied in to ICHQ7
- Costs and benefits of manufacturing Excipients in compliance with ICH Q7 guidelines
- Implementation of ICHQ7
- Quality Management and Creating Quality Units
- Record and Documentation
- Differences in Registration for Market Authorizations
- Material Management
- Impact of ICHQ7 on Second and Third Parties
- Evaluation of Suppliers
- Cleaning Validation GMP in Laboratory Control
- Change Control
- ICHQ7 Section 18 - A Chapter On Its Own?
- Differences between API’s manufactured by Cell Culture / Fermentation to APIs manufactured by Chemical Synthesis
- Audit Preparation with Consideration to GMP and ICH Requirements
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