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Pharmaceutical Inspection
Co-operation Scheme (PIC/S) Leading the international development, implementation, and maintenance of harmonized
GMP standards and quality systems of Inspectorates in the field of medicinal products, PIC/S has revised the guidance document for GMP INSPECTION RELATED TO PACKAGING on 19 January 2021, (Geneva), PI 028-2 Aide-Memoire on Packaging The revision process consisted in updating the cross-references to the PIC/S GMP Guide. No other changes were made. The revised Aide Memoires enter into force on 1 January 2021. The purpose of PI 028-2 Aide-Memoire is to provide guidance for GMP inspectors in preparation for inspections. This document aims to define the minimal requirements acceptable for an inspector as well as the requirements that provide maximum safety for the finished product (“best practices”). The Aide-Memoire should enable the inspector to assess the GMP compliance of the packaging process using the quality risk management tools. The PI 028-2 Aide-Memoire on GMP INSPECTION RELATED TO PACKAGING has described different areas that could be evaluated during the GMP inspection of the packaging and labeling process. However, the Aide-Memoire should be considered as a non-exhaustive list of areas to be looked at during an inspection. The document is describing following points; Quality and Purchasing of Packaging Material Receipt of Packaging Material Storage Area of Packaging Material Quality Control checks for Packaging Material Manufacturing Premises (Packaging Area) Requirement Packaging Equipment and Process Documentation related to Packaging Material and Packing activity Requirement related to the Personnel engaged with the Packing activity and Packaging material handling The Quality Assurance consideration for Packaging Material and Packing activity To read the entire Aide-Memoire published by PIC/S Click here This Short Note is published as a news update only; however, the detailed article on GMP INSPECTION RELATED TO PACKAGING will be available shortly. Dear readers; I am Inviting you to become a part of the DPT Family (Dynamic Pharma Team.
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