9
Regulatory Affairs
Learning Objectives
- GMP and its importance in pharmaceuticals
- Techniques of QA and QC in pharmaceuticals
- US FDA and MHRA guidelines
- Registration dossiers
- Technology transfer in pharmaceuticals
GOOD MANUFACTURING PRACTICES
Good Manufacturing Practices (GMP) is a part of Quality Assurance (QA) that ensures that products are consistently produced to the quality standards appropriate to their intended use and also to ensure that they meet the requirements of market or product specifications. GMP includes both production and Quality Control (QC). The manufacture of pharmaceuticals must be carried out by current methods as a requirement that is accepted in the pharmaceutical industry in terms of equipment, methodology, controls ...
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