QA System should ensure:
Products are designed and developed correctly
- Complying with, e.g. GMP, GCP, GLP
Production and control operations are defined
Managerial responsibilities are defined
- In job descriptions
The manufacture, supply and use of correct starting and packaging materials
A lot more detail on each of these topics will follow during the course of this training programme. However, this list may serve as a basis to determine whether each element of GMP has been addressed.
A comprehensive QA system has to be developed and implemented which fulfils a number of requirements:
1. It must ensure that products are formulated and developed in accordance with quality assurance principles. Product quality begins with the development process. All of the development work should be undertaken with a commitment to quality assurance. This will enable easier adherence to quality assurance principles in the other areas of manufacturing.
2. It must ensure that all production and control operations are defined
3. It must identify all management responsibilities, with written job descriptions and organization diagrams. This will assist in ensuring that there are sufficient qualified and experienced people available who have the correct training to carry out their responsibilities.
4. It must ensure the manufacture, supply and use of correct starting and packaging materials