The Ministry of Food and Drug Safety will be amending the ‘Regulations for Good Manufacturing Practices for Medicinal Products’ as preannounced ahead of PIC/S re-evaluations.

The main point of the amendment is to amend the GMP for sterile medicinal products to align with those of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This includes the establishment of a contamination control strategy through quality risk management and the establishment of management standards for the latest aseptic manufacturing equipment and technology.

The main purpose of the amendment is for the MFDS to prepare for the PIC/S reevaluations that will be he