Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 917, 2003, Annex 2
(2003; 19 pages)


The storage, trade and distribution of pharmaceutical starting materials are activities that are not only carried out by companies that manufacture pharmaceutical starting materials. The nature of the risks is generally the same as that of those encountered in the manufacturing environment, e.g. mix-ups and cross-contamination. Therefore, there are aspects in trading and distribution where the implementation of good manufacturing practice (GMP) would be beneficial. These include, but are not limited to, packaging, repackaging, labelling, relabelling, storage, distribution and documentation and record-keeping practices.

WHO is concerned about the quality of materials used for the manufacture of pharmaceutical products because the quality of the pharmaceutical starting materials can be affected by the lack of adequate control of activities including packaging, repackaging, labelling, relabelling, storage and distribution of the materials used in pharmaceutical products.

Packaging, repackaging, labelling, relabelling, storage and distribution are the usual practices of a number of parties involved in the trade and distribution of pharmaceutical starting materials, including traders, brokers and distributors. Other activities include the issuing of Certificates of Analysis. Improper trading practices (e.g. packaging, storage and distribution) can pose a significant risk to the quality of pharmaceutical starting materials. Experience has shown that activities such as repackaging and relabelling, in particular, can increase the risk of contamination, cross-contamination, mix-ups, degradation and changes in physical properties.

To maintain the original quality, all activities such as packaging, labelling and retesting of materials should be carried out according to GMP, good storage practice (GSP) and good trade and distribution practice (GTDP).

This guideline is a stand-alone text. However, there may be some overlap with other guidelines such as those for GMP and GSP.

These guidelines are applicable to all persons and companies involved in handling pharmaceutical starting materials (i.e. active pharmaceutical ingredients (APIs) and excipients), including the materials removed during the process of pharmaceutical product manufacture.

The guidelines apply to all parties involved in trade and distribution, brokers, suppliers, distributors, traders, transport companies, forwarding agents, processors, etc.

All materials designated or intended to be used as pharmaceutical starting materials are covered by these guidelines, from the point at which the starting material is identified or designated as being for pharmaceutical use.

The guidelines apply to every step in the distribution and supply chain.

Persons and companies performing processing activities, such as mixing, micronization, relabelling or repackaging of pharmaceutical starting materials, should also comply with all relevant aspects of GMP.

In addition to this text, the good storage practices for pharmaceuticals are applicable.

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