WHO TRS (Technical Report Series) 917 Annex 2

Good trade and distribution practices for pharmaceutical starting materials

Introductory note:

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.

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WHO TRS (Technical Report Series) 917 Annex 2: