GXP Inspection & Lab Accreditation
【Update Date:2018-10-18】unit:品質監督管理組
GDP is the abbreviation of Good Distribution Practice. As markets globalize, the supply chain for medicinal products by the air, sea, and land transportations are becoming more and more complex. For the past few years, in particular, improper management of drug storage and transportation has resulted in no small number of drug recalls due to poor quality. There have been cases of counterfeit drugs entering the legitimate supply chain, too. This is the reason international competent health authorities, such as those in EU member states, the United States, Canada, Australia, Singapore, and Malaysia are paying more and more attention to distribution management of medicinal products.
The goals of implementing the GDP include ensuring the quality and package integrity of all medicinal products delivered to patients can be maintained during storage and transportation; emergency drug recalls are handled effectively; that medicinal products are delivered to customers correctly and within a reasonable period of time; and that counterfeit drugs may be prevented from entering the supply chain, among others. As an extension of the rigid quality management honored through GMP, drug quality management is broadened to cover the whole drug supply chain, thus ensuring quality and safety of medicinal products for the general public.
In order to develop a national pharmaceutical GDP management system in line with international standards, the Food and Drug Administration (TFDA) has been promoting the system as an outsourced project since 2011. Through the process, regulations and management mechanisms related to GDP were collected from other countries and drug international conferences were held. Relevant industry briefings, topic forums, technical seminars, observational and assistance-oriented visits to logistics factories, among other educational training events, were further organized.
With reference to the PIC/S GDP, the Guide to Good Manufacturing Practice for Medicinal Products (Part III: Distribution) were officially announced on July 16, 2015, providing businesses with an implementation reference. The Implementation Items and Schedule of the Guide to Good Manufacturing Practice for Medical Products (Part III: Distribution) and a clarification letter regarding compliance with requirements that pharmaceutical companies holding the drug permits licenses, were announced on February 18, 2016. It is required that, as of July 1, 2016, pharmaceutical manufacturers (including medicinal gas manufacturers) and logistics companies engaging in labeling and packaging operations of western pharmaceutical products as newly established, relocated and business resumption , shall meet the requirements of GDP when applying for the GMP inspection, as well as when pharmaceutical companies applying for their first drug permits licenses. For companies other than those mentioned above, on the other hand, shall comply with GDP by December 31, 2018.(First stage implement)