Malaysia's NPRA has released an analysis of the Deficiencies Found During On-Site Good Manufacturing Practises (GMP) Inspections of Domestic and Foreign Manufacturing Facilities of Medicinal Registered Products in the Year 2022.
52 GMP inspections of pharmaceutical plants were carried out by NPRA last year, and two of them resulted in findings that required regulatory action. Based on the Pharmaceutical Inspection Co-operation Scheme's (PIC/S) guide to GMP for pharmaceutical products, NPRA split its examination of the flaws found by its inspectors.
Inspectors found serious flaws in four of the guide's chapters: production, personnel, premises and equipment, and pharmaceutical quality system (PQS). With three issues related to PQS and two for each of the other chapters, the number of critical deficiencies observed in 2022 was distributed fairly evenly across the chapters. However, the NPRA identified four GMP requirements across three chapters as areas in which critical and major deficiencies frequently occur.
Detailed assessment of the GMP deficiencies analysed by NPRA can be accessed here.