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The course covers the need for and history of Pharmaceutical GMP as well as the key GMP requirements at the various parts of a pharmaceutical manufacturing site, from goods-in to despatch of the finished product. The Advanced GMP training course is based on the requirements of UK and European Union (EU) GMP, with comparison of this to other GMPs also provided. Delegates will leave the course with a very clear and well rounded knowledge of the requirements of Pharmaceutical GMP and how to apply these in the workplace.

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.

Content

Why do we have GMP?

• The history of GMP
• Approval of medicines and manufacturers

GMP – 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

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

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 – 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

Prerequisites

Some GMP experience is helpful.

Additional information

This course is presented virtually. It can also be presented in-house.