On 01 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released a guidance document for good manufacturing practice(GMP) inspections for non pharmaceutical category (health supplements, traditional medicines and cosmetics) manufacturers. The guideline is established for inspection during pre-licensing, initial or pre-approval for existing manufacturer. The documents are not meant to replace the existing guideline in which the inspections are based on.
A regulatory flow description is included in the guidance document, further which elaborates that manufacturer needs to ensure that the layout of manufacturing facility is satisfactory as per GMP principles. The next stages will involve issuance of approval letters which will become the pre-requisite of pre-licensing/initial inspection.
Manufacturers especially cosmetic manufacturers will need establish the quality management system to overlook documentation and records, facilities and equipment system, production system, packaging and labelling system and laboratory control system and material system.
The document outlines the submission for inspection through QUEST system which requires the site master file and letter of approval for facility layout. The guideline details the procedures of the inspection which will be conducted based on the GMP and Good Distribution Practice(GDP) guideline.
In the event manufacturer fails in submitting satisfactory documentation via QUEST system and Pre-Inspection Checklist within specified period, the manufacturers‘ application will be rejected.
The guidance document could be obtained from :-