Malaysia Releases Guidelines for Application for Inspections of GMP and GDP

Background:

In Malaysia notified cosmetics are required to be manufactured in a manufacturing facility that is compliant with the current Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements. Therefore, to ensure compliance, GMP Section from Centre of Compliance and Quality Control (CCQC), National Pharmaceutical Regulatory Agency (NPRA) will conduct various types of inspection onto these manufacturers.

A new local manufacturer for notified cosmetics is required to be inspected prior to cosmetics notification. Therefore, they are subjected to different types of inspection i.e. Pre-Licensing Inspection where GMP inspection conducted on local manufacturing facilities prior to being licensed, or Initial Inspection for new cosmetic local manufacturers, whereas for an existing local licensed manufacturer, a Pre-Approval Inspection will be conducted for a new production line. The main objective of a pre-licensing / initial inspection / pre-approval inspection is to assess the manufacturer's readiness for commercial manufacturing or the new manufacturing line of an existing manufacturer.

On July 1, 2020 Malaysia NPRA implemented a guidance document which specifies the requirements and procedures for new cosmetic local manufacturers to apply for a pre-licensing, initial inspection or pre-approval inspection for existing manufacturers.

Brief Regulatory Flow

1. Prerequisite Requirements for Applications for Inspection

Apply for evaluation of manufacturing plant layout

Prior to applying for pre-licensing / initial inspection, the manufacturer needs to ensure that the layout of the manufacturing facility is designed and planned according to GMP principles. The proposed layout along with the Application Form for Evaluation of Manufacturing Plant Layout (BPFK-503) and supporting documents may be submitted to GMP Section, CCQC for evaluation. An approval letter of the proposed layout will then be issued when it is deemed satisfactory.

This may also be applicable for pre-approval inspection application, especially if the existing manufacturer undergoes major changes to its facility (may refer to Managing Changes of Manufacturers Facility from Drug Registration Guidance Document, DRGD) 

Establish a Quality Management System (QMS) 

Upon the approval of the facility layout plan and approval from other relevant authorities’ such as the local authority and fire brigade department (BOMBA), the manufacturer shall complete the establishment of the QMS for the facility according to the requirements of current GMP and GDP. QMS is an overall system, consisting of the quality system, documentation and records, facilities and equipment system, production system, packaging and labeling system, laboratory control system and material system.

Thus, it is advisable for the manufacturer to self-assess its own quality system as part of the preparation before inspection conducted by NPRA. For companies who procure/ transfer ownership of an existing GMP manufacturing business, it is the responsibility of the new owner to ensure that the GMP manufacturing facility complies with the current GMP and GDP requirements. The new owner must not rely solely on purported claims but is encouraged to self-assess the current state of the facility.

2. Application for Inspections

Before submitting an application for inspection, manufacturers need to ensure that all the necessary renovations and installations are completed. The following required documentation should also be updated and submitted through the QUEST system:

• Application form

• Site Master File

• Letter of approval for facility layout 

After the submission of the inspection application via the QUEST System, a pre-inspection checklist (Appendix 1 in the guidance document) is required to be submitted within 10 working days to the office of the GMP Section. And a fee of RM 1000 is applicable for each inspection conducted within 1 day. However, if the inspection is expected to take more than 1 day due to the complexity of the site, process and product, the fee will be revised according to the number of inspection days and number of inspectors. The manufacturer will be advised further for this scenario. 

For a satisfactory evaluation of the application, the following procedures will be implemented:

• The pre-licensing / initial / pre-approval inspection will be scheduled by the assigned inspector

• The manufacturer will be notified of the date and time of inspection by email or telephone.

• After the inspection, the inspector(s) will issue a report to the manufacturer within a predetermined timeline. An acceptable GMP status will be given if the manufacturer is able to comply with the required GMP principles and within the inspection scope.

• The inspected manufacturer is then subjected to routine GMP inspection by NPRA to ensure the compliance to GMP requirements are met and maintained.

Whereas, if the outcome was found to be unacceptable because of significant non-compliance with GMP, the manufacturer is required to conduct a complete Corrective Action and Preventive Action (CAPA) before submitting a new application (with payment). The CAPA report will be requested by NPRA as part of the preparatory document for the new inspection.