Good Distribution Practice (GDP) is a part of quality assurance that ensures the quality of products is maintained through adequate control of the various activities that occur throughout the supply chain. The National Pharmaceutical Regulatory Agency (NPRA) has established principles and measures in the Malaysia Guideline on Good Distribution Practice for distributors (including manufacturers, importers, and wholesalers) to follow during the distribution process. NPRA is responsible for conducting inspections to verify that the storage and distribution operations of products, cosmetics, and associated materials comply with these standards.

 

GDP inspections in Malaysia are carried out by inspectors from NPRA's GDP Section or the Pharmacy Enforcement Division. These inspections primarily involve on-site visits, although alternative methods like remote inspections or distant assessments may be used when necessary. Importers and wholesalers are routinely inspected using a risk-based approach to ensure compliance with GDP guidelines. Authorities also conduct non-routine inspections, including pre-licensing and for-cause/special inspections.

 

The frequency of GDP inspections is determined using a combination of compliance and intrinsic risk scores. These scores consider the level of compliance observed in the most recent inspection, the complexity of distribution activities, and the criticality of products, particularly for items that require cold chain management. The duration and number of inspectors involved in each inspection vary depending on the complexity of activities at the site and the findings of previous inspections.

 

A report is generated to document any deficiencies identified upon completion of a GDP inspection. These deficiencies are categorized as critical, major or minor based on predetermined criteria.

 

NPRA systematically reviews data on GDP inspection deficiencies to:

• Identify the severity and frequency of deficiencies associated with the Malaysia Guideline on Good Distribution Practice.
• Enable the industry to assess the deficiency findings as part of self-inspection and continuous improvement activities.

 

The GDP inspection deficiency data is regularly reviewed, considering trends from previous years. This analysis focuses exclusively on GDP inspections and excludes deficiencies identified during Good Manufacturing Practice (GMP) inspections. The data covers all deficiencies, regardless of classification, providing a comprehensive view of compliance challenges. The reports use graphical presentations to highlight the most frequently cited chapters / annexes and clauses in the Malaysia GDP Guideline, focusing on the top five in each category. This visual approach facilitates a clearer understanding of recurring issues, helping stakeholders prioritize corrective actions effectively.

Updated 1 November 2024