An Analysis of Deficiencies Observed During On-Site Good Manufacturing Practice (GMP) Inspections of Local and Foreign Manufacturing Premise of Medicinal Registered Products in the Year 2022
1.0 INTRODUCTION
As a secretariat of the Drug Control Authority (DCA), the National Pharmaceutical Regulatory Agency (NPRA), the Ministry of Health is responsible for ensuring the quality, safety, and efficacy of registered products and notified cosmetics.
The Good Manufacturing Practices (GMP) Section, Centre of Compliance and Quality Control (CCQC) is in charge of performing GMP inspections on local and foreign manufacturing facilities, which include:
- Pharmaceutical products (including scheduled poisons and over the counter products and medicinal gasses)
- Biologic products including Cell and Gene Therapy Products (CGTPs)
- Traditional/herbal products
- Health supplement products
- Cosmetics
The pharmaceutical products, Biologics products, Traditional/herbal products and Health supplements products are regulated as registered products. Hence, the manufacturers are required to apply for a license in order to conduct manufacturing activities. However, cosmetic products are regulated as notified products and do not require license prior to manufacturing activities.
For CGTPs, it is regulated under the listing programme until the year 2024 and requires full registration and license starting in 2025.
For medicinal gasses, it is regulated under voluntary registration until year 2022 and is required full registration and license starting in 2023.
The types of inspection that are performed by GMP Section includes:
Announced inspection:
- Pre-Licensing inspection
- Initial audit
- Pre-approval inspection
- Routine inspection
- Verification inspection
- Pre-certification inspection
Unannounced inspection:
- Investigation inspection
For CGTPs, pre-certification inspection will be conducted until the year 2022. Pre-licensing inspection will only commence in 2023.
The main guidelines to be referred during GMP inspection are:
- PIC/S GMP Guide
- Guideline on Good Manufacturing Practice for Traditional Medicines and Health Supplements
- Guidelines for Cosmetic Good Manufacturing Practice, Guidelines for Control of Cosmetic Products in Malaysia
The observation during an inspection (either good point or deficiencies) will be reported in the respective chapters:
- Pharmaceutical Quality System/ Quality Management System
- Personnel
- Premise and Equipment
- Documentation
- Production
- Quality Control
- Outsourced activities/ Contract manufacture and analysis
- Complaint and recall
- Internal audit
- Shipment and Distribution
Each deficiency will be classified as minor, major and critical based on the risk impact to the products manufactured.
2.0 PURPOSE
- To comply with Indicator RI06 Mechanism exists to promote transparency, accountability and communication for the purpose of WHO Global Benchmarking Tool (GBT)
- To promote transparency, accountability and communication within inspectors as well as inspectorate and industry
- To improve mutual understanding and involvement of all manufacturers relevant to inspection activities by NPRA
3.0 SCOPE
- Only applicable to routine inspections, conducted on-site towards local manufacturing premises of pharmaceutical products, biologic products, traditional/herbal medicines and health supplements.
- Manufacturing premises of CGTPs and medicinal gasses are excluded as both products are currently under listing/voluntary registration program by NPRA.
- Manufacturing premises of cosmetic products are excluded, as it is not considered as medicinal products under WHO GBT Benchmarking program.
The data analysis can be referred in the following Appendices:
| Document | Download |
|---|---|
| Inspection Metrics 2022 | |
| Deficiency Statistic (Pharmaceutical 2022) | |
| Deficiency Statistic (TMHS 2022) |
Note: Should you have any additional queries, kindly contact GMP Section, Centre for Compliance & Quality Control at 03-7883 5491.