Good Manufacturing Practices in Chemical Development

Outline

• GMP - Basic concepts, philosophy and its place in Chemical Development
• Quality Management Systems - ISO 9000
• Documentation Systems
• Standard Operating Procedures
• Personnel & Training
• Specification for raw materials, intermediates and APIs
• Control of Impurities
• Material Handling Procedures
• Equipment & Facilities
• Equipment Clean Up & Cleaning Validation
• Calibrations
• Qualification (IQ & OQ)
• Process Control
• Process Analytical Technology
• Process Validation
• Change Control
• Critical Parameters & Operating Ranges
• Development Reports
There will also be numerous problem-solving sessions and time for interactive discussions.

The modern pharmaceutical industry is a pervasively regulated business; the influence of drug regulatory authorities (FDA, MHRA, EMEA etc) extends beyond the pharma industry itself, and reaches also suppliers of raw materials and intermediates. In recent years, the European Clinical Trials Directive and the Q7A guidelines for active ingredients have signalled increasing regulatory interest in the development and manufacture of clinical supplies. Thus regulatory issues and GMP now constitute an important factor in the development chemist's work.
The modern development chemist must not only devise efficient processes for transfer to manufacturing, but also ensure the high quality of clinical and bioequivalence batches by appropriate control and documentation of the procedures used. An awareness of the requirements of the various regulatory agencies is thus essential for the successful outcome of a project.

This course considers these regulatory aspects of the fine chemical and pharmaceutical industries, with the emphasis on their practical application in chemical development. Its purpose is to encourage chemists based in lab or pilot plant to develop a perspective on GMP which places it in the context of their work.

The course is at an introductory level, and consists of lectures, problem-solving sessions and interactive discussions.

Upon completion of the course, participants will have gained:

Knowledge of the background to GMP regulations and guidelines, and their relevance in the laboratory and pilot plant.
• Appreciation of the important regulatory issues in the four key areas of personnel, materials, equipment and processes.
• Ability to develop useful documentation such as Standard Operating Procedures and Batch Processing Records.
• Appreciation of the development chemist's role in preparing for a successful process validation.

Above all, the course will have made chemists think more clearly about the steps that need to be taken within their own companies to comply with regulatory requirements and to improve the quality of their products.