Challenges in cGMP, GCP & Regulatory Affairs
GMP ensures that quality is built into the organization and processes involved in the manufacture of the products and all those operations should be carried out strictly according to cGMP. Current Good Manufacturing Practices, formal regulations contained in statutes and agency policies and concern the design, monitoring and control of manufacturing processes and facilities. GCP (Good Clinical Practice) is an international ethical and scientific quality standard for the performance of a clinical trial on medicinal products involving humans. GCP includes all aspects of a clinical trials. Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines
- Sterile pharmaceutical or biological medicinal products
- GMP regulations
- Regulatory requirement of pharmaceutical products
- Health care regulatory affairs
- Clinical safety data management
- Clinical investigation of medical devices