Singapore: Updated Good Distribution Practice Guidelines for Pharmaceuticals

Recently, the Health Sciences Authority (HSA) released new guidelines on Good Distribution Practices (GDP) for pharmaceutical materials and products in Singapore. The new guidance, effective January 1, 2005, includes new and updated information on the GDP documentation system, electronic records, EEFO (Earliest-Expiry-First-Out) and FIFO (First-In-First-Out), and the handling of active pharmaceutical ingredients (APIs) and intermediates. The HSA issued the new guidelines in order to better ensure the reliability and quality of pharmaceutical materials and products during the distribution process.

Under the updated guidelines, some of the changes and new requirements are as follows. First, companies will be required to establish procedures for developing, controlling, and maintaining documentation related to the distribution process. The company should keep these documents up-to-date and have them readily available upon request. Second, if records are also maintained by electronic data systems, a detailed description and explanation of the system should be created. Any changes made to the data should be electronically recorded and can be used as reference information in the case of an audit. Third, companies will be required to develop an EEFO/FIFO system to help avoid distributing products with approaching expiration dates. Finally, anyone who distributes, trades, or stores APIs or intermediates in Singapore will need to maintain documents for tracing these products. Documents that allow for traceability should include the name and address of the original manufacturer, purchase orders, batch numbers, transportation information and Certificates of Analysis.