AUDIT/Inspection of Third-Party Manufacturers (excluding sterile dosage forms): 1-day Workshop for Applicants based on PIC/S GMP requirements
Topics covered
- Requirements for Third-Party Manufacturer Inspections according to PIC/S GMP
- SAHPRA expectations regarding inspections of Third-Party Manufacturers by applicants
- What should be inspected according to the PIC/S GMP guideline
- Guidelines and tips for inspection of manufacturers producing specific dosage forms such as Tablets, Capsules, Creams, Ointments, Effervescent Powders, Suspensions and Liquids
Learning Objectives
After the workshop, the learner will have an understanding of
- Why and when 3rd Party Manufacturers must be inspected
- What is the expectation of SAHPRA in terms of 3rd Party Manufacturer Inspection by applicants
- What guidelines can be used to aid 3rd Party Manufacturer inspections
- The inspection process
- How to use the PIC/S GMP guideline and Annexes to conduct an inspection
- Important inspection points for specific dosage forms: Tablets, Capsules, Creams, Ointments, Effervescent Powders, Suspensions and Liquids
The course is suitable for personnel in QA or RA positions with minimal manufacturing or inspection experience or exposure.