AUDIT/Inspection of Third-Party Sterile Manufacturers: ½ Day Workshop for Applicants based on PIC/S GMP requirements
Topics covered
- Where and why additional care must be taken for manufacture of sterile products
- Important elements of the sterile manufacturing facility
- Requirements for inspection of manufacturers that produce sterile dosage forms according to PIC/S GMP, specifically Annex 1
- Guidelines and tips for inspection of manufacturers producing dosage forms such as Eye Drops, Injections and Infusions
Learning Objectives
After the workshop, the learner will have an understanding of
- Where and why additional care must be taken for manufacture of sterile products
- Important elements of the sterile manufacturing facility
- Requirements for inspection of manufacturers that produce sterile dosage forms according to PIC/S GMP, specifically Annex 1
- Tips on specific things to consider for inspecting manufacturers of sterile products
The course is suitable for personnel in QA or RA positions with minimal manufacturing or inspection experience or exposure.