The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia decided to enforce stringent measures against cosmetics manufacturers who have repetitive non-compliance records effective from 1 July 2024, in response to the rise in cosmetic manufacturers with “Unacceptable" GMP status during the GMP inspection since 2014. Besides, some cosmetic manufacturers consistently recorded repetitive non-compliance records with the “Unacceptable” status based on the previous GMP inspections.
As part of the initiative to uphold the safety and quality control of the notified Cosmetics, NPRA rolled out a thorough review of the coordination of the regulatory actions to address the need for a consistent and effective approach towards the cosmetic manufacturers with repetitive GMP non-compliance records following Annex 1 Part 11, Guideline for Cosmetic Good Manufacturing Practice, August 2022 and Guidelines for Good Distribution Practice, Third Edition, 2018.
Hence, the Committee Assessment Meeting for Premises Inspection and Study No. 9/2023 ruled out that NPRA will enforce stringent measures for cosmetics manufacturers with repetitive non-compliance in performance records, in which previous five (5) routine inspections or GMP investigation inspections will be referred to determine the regulatory actions that will be imposed as stated in the table below:
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