Pharmaceutical manufacturers are required to meet and maintain Good Manufacturing Practice (GMP) as a condition of the licence granted by the regulatory authorities.
The manufacture of pharmaceutical products requires the establishment and implementation of a ‘Pharmaceutical Quality System’ (PQS). The concepts of QM (Quality Management), GMP and Quality Control (QC), which are inter-related, form the basis of such a system for the manufacture and testing of pharmaceutical products from initial development, through clinical phases to commercial and supply. Hence, the delivery of GMP requires the establishment and implementation of an effective PQS.
This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
Benefit of Attending
- Understand the legal requirements and how to comply
- Learn the key elements and role of the PQS
- Know your operational responsibilities
- Gain insight in to the principles of the ‘The Orange Guide’
- Understand the key requirements of CAPA and Change Control
- Consider the key elements of supply chain management
- Get an introduction on how to prepare for regulatory inspections