Who will the course benefit?
This course is aimed at people who work in Quality Assurance, Quality Control and Production personnel who need a greater appreciation of GMP than is often offered via traditional in-house GMP awareness training courses. The course is aimed at team leader and junior management level and is used as a development course for people who are to be managers of the future. The course is ideal for people who are new to the pharmaceutical industry and are in a role where a very good working knowledge of GMP is essential.Course overview:
This course is presented over 3 days and provides a real depth of information on the main aspects of pharmaceutical GMP. During the course the main GMP requirements for purchasing, goods-in, the warehouse, production, packaging, Quality Control and batch release are covered. In addition, the course also covers the main elements of the Quality Management System needed to provided medicines of the highest quality, including the requirements for documentation, training and system monitoring and review. The course is full of interactive exercises and workshops throughout the programme.We also offer a 1-day course for those people who need more of an overview of GMP - visit our website for more details.
Course contents:
Day 1: The reasons for GMP and GMP in facility design
Why do we have GMP?
- The history of GMP
- Why do we have GMP?
- Approval of medicines and manufacturers
GMP 鈥� rules and guidelines
- European Union (EU) GMP and the EU Guide to GMP
- GMP in the United States
- Other GMPs from around the world
Premises and facility design
- Suitable premises and facility design
- Heating, Ventilation and Air-Conditioning systems
- Access, security and pest control
Equipment, maintenance and calibration
- Selection of equipment and installation
- Planned Preventive Maintenance (PPM)
- Calibration of measuring equipment
Validation, qualification and change control
- The differences between validation and qualification
- The different stages of validation
- The importance of controlling changes
Water systems
- The different types of water
- Water system design, construction and monitoring
Day 2: GMP in practice 鈥� incoming materials to product release
Purchasing, incoming materials, suppliers and outsourced activities
- GMP requirements for incoming materials
- Supplier selection and control
- Control of outsourced activities
The warehouse
- Control of incoming materials
- Storage of materials
- Issue of materials to production
- Control of rejected and returned materials
Manufacturing
- Different types of dosage forms
- Initial checks of the area, equipment and materials
- Documentation and records
- Reporting of problems
- Cleaning of the equipment and area
Packaging
- Packaging equipment design and facility layout
- Control of materials and product
- Overprinting of artwork
Quality Control
- Good Control Laboratory Practice
- Test specifications and pharmacopoeias
- Analytical method validation and method transfer
- Recording of results and release of materials
- Ongoing stability storage and testing
Day 3: GMP and the Quality Management System
People and training
- Organisation charts, job descriptions and training records
- GMP, hygiene and job specific training
- Training design and evaluation
Key personnel in GMP
- The Heads of Production, QC and the Qualified Person
- The role of Quality and Quality Assurance
- The importance of Senior Management
Documentation, records and data integrity
- Control and approval of documents and records
- Data Integrity and regulatory concerns
- The use of computer systems
Quality Risk Management
- The need to make decisions based on risk
- ICH Q9 and its requirements
- Reactive and proactive risk assessments
Deviations, incidents and complaints
- CAPA systems 鈥� good and bad points
- Problem-solving and root-cause analysis
- Dealing with complaints effectively
Specific GMP requirements for certain types of products
- Sterile products manufacturing
- Biological products
- Advanced Therapy Medicinal Products
The Quality Management System
- Batch review and release
- Product Quality Review
- Internal auditing
- Management review
- Continual improvement
- The requirements of ICH Q10
