Among GMP other aspects, API manufacturing Quality systems, environmental controls, and safety, are necessary to be taken into account in order to be in compliance with regulations. Business efficiency and continuous improvement are needed to be competitive. Therefore, GMP compliance should be incorporated into an overall Quality Management Systems (QMS) as it is recommended in the EU GMP philosophy and ICH Q10 ensuring benefit to the patient.
Whether electronic or manual systems and records are used for all GMP Quality system requirements of ICH Q7, data integrity needs to be maintained. The importance of an effective QMS on customer relations, continuous improvement, regulatory compliance, inspection readiness and supports ensuring supply of drug products to the market.
Each trainee Will benefit from The practical knowledge of Handling of API Quality Systems Elements and Updates w.r.t USFDA; EIdralex Volume -part II; WHO and PIC(s) like: –
- Introduction
- Quality Management
- Personnel Requirement
- Buildings and Facilities
- Process Equipment
- Documentation and Records
- Materials Management
- Production and In-Process Controls
- Packaging and Identification Labelling of APIs and Intermediates
- Storage and Distribution
- Laboratory Controls
- Validation
- Change Control and its Updates
- Rejection and Reuse of Materials
- Complaints and Recalls
- Contract Manufacturers and Contract laboratories
- Agents, Brokers, Traders, Distributors, Re-packers, and Re-labelers
- Specific Guidance for APIs Manufactured by Cell Culture/Fermentation
- APIs for Use in Clinical Trials
- Question and answer section
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Validation Departments
- Documentation Departments
- Supply Chain Departments
- All API and Formulation Companies
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