The responsibility of a pharmaceutical handler is higher than other manufacturers as the quality of the pharmaceutical products may severely affect the health of the patients and sometimes may even cause death. Every manufacturer, distributor and traders shall follow good trade and distribution practices and shall do risk assessment of there procedure and prctices to maintain the original quality of their products. Also the starting material which is added in the pharmaceutical product shall also be included in the scope of risk assessment
The risk during storage, trade and transports are generally similar to those of manufacturing environment. The risk such as packaging, repackaging, labelling, relabelling, storage, distribution and record keeping practices can lead to a substandard drug.
Therefore WHO is concerned to control such risk for the pharmaceutical product. In order to control the risk of contamination, cross-contamination, mix-ups, degradation and change in physical properties of pharmaceutical products guidelines are provided by WHO.
- WHO TRS No. 957 :2010 (Annex 5) "Good distribution practices for pharmaceutical products" are the guidelines where control of risk is mentioned for directly consumable pharmaceutical products.
- WHO TRS No. 917: 2003 (Annex 2) "Good trade and distribution practices for pharmaceutical starting material are the guidelines where control of risk are specified for starting material which are used in pharmaceutical product as API or excipients.
Good trade and distribution practices for pharmaceutical starting material WHO TRS No. 917 Annex 2
The guidelines are applicable to all the parties which are involved in handling trade and distribution of the starting material of the pharmaceutical products. The prime objective of this guidelines is that the user (usually a patient) who is consuming the drug does not get affected by using a substandard pharmaceutical product.
All parties involved in manufacture and supply chain must share responsibility for the quality and safety of the materials to ensure that they are fit for the intended use. Each step is crucial to prepare a well maintained supply chain system. There shall be a knowledgeable team who have expertise in supply chain. Each person responsibility must be clear.
The guidelines have many portions which overlap the good manufacturing procedures, For example
- Maintenance of the premises
- Warehousing and storage
- Usage of c-GMP Equipment
- Good recording practices and record keeping.
- Repackaging and relabelling.
- Handling of market complaints
- Product recall
- Handling of returned goods
- Handling of Non conforming products
- Dispatch and transports.
Each manufacturer, traders and brokers shall have well defined procedures on the above points which will comply guidelines on GMP as well as GTDP. These procedure may be prepared as separate procedure or as part of GTDP.
After preparing a well established procedure the parties shall conduct a risk assessment on the distribution practices.
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