pharmacovigilance/ medical affairs Third party manufacturers/packers/FPRC: to assist with the review BMR/BPR/Stability to SAHPRA; to prepare documentation required for shelf-life extension variations Site transfer process:
pharmacovigilance/ medical affairs Third party manufacturers/packers/FPRC: to assist with the review BMR/BPR/Stability to SAHPRA; to prepare documentation required for shelf-life extension variations Site transfer process:
regional office), final product release laboratories, packers, warehouses and distributors of products, and confirm Ensure that all manufacturers, laboratories, packers, warehouses and distributors of products have the our products are stable throughout the approved shelf life. Ensure that analytical methods are validated
regional office), final product release laboratories, packers, warehouses and distributors of products, and confirm Ensure that all manufacturers, laboratories, packers, warehouses and distributors of products have the our products are stable throughout the approved shelf life. Ensure that analytical methods are validated
calibration/services as well as maintaining the shelf-life of all records of chemicals within the storeroom
calibration/services as well as maintaining the shelf-life of all records of chemicals within the storeroom
phases of the product, in-process, release and shelf life and analytical methods if required and confirm confirm that our products are stable throughout the shelf life Ensure that Product Quality Reviews are available
phases of the product, in-process, release and shelf life and analytical methods if required and confirm confirm that our products are stable throughout the shelf life Ensure that Product Quality Reviews are available
lacking that will have a direct impact on quality and shelf life of packed product. Facilitate access to premium safety/chemicals Cold chain integrity: Traceability, shelf life optimization Audit plans developed and implemented
received and raw materials. Management of retainer and shelf life samples. Preparation of chemical solutions