Inside IPEC: Good Distribution Practices for Pharmaceutical Excipients - Pharmaceutical Technology

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Inside IPEC: Good Distribution Practices for Pharmaceutical Excipients
The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 5

Returned goods are excipients a distributor receives back due to recalls, complaints, or other reasons. Such material should be quarantined and fully investigated before any consideration is made regarding the goods' rejection or re-use. This process should be fully documented.

Dispatch and transportation is the final step in the excipient supply chain. This process has the same potential impact on product quality as warehousing and/or repackaging. All transport processes should be designed and documented in the same way as warehousing processes. This should include a focus on prevention of product deterioration through adequate transport conditions, maintenance/full traceability of appropriate shipping documentation, and adequate flow of all relevant information (e.g., conditions for storage and transportation, original manufacturer). In case products are transported in bulk tanks, special procedures should be in place to avoid contamination of the products by transport equipment. These procedures should include documented control and maintenance of the equipment (e.g. bulk trucks, seals, hoses, pumps), defined and documented cleaning procedures, and restricted prior-cargos. The use of dedicated equipment has to be considered as the best solution.

Contract activities are activities contracted out to a third party and may include laboratory analysis or transportation. In these cases, GDP requires written contracts to be in place between the distributor and the contractor. Thorough evaluation and control of contractors, including auditing, should ensure that contractors follow the same GDP principles.

GDP auditing

In 2008, the IPEC–Europe GDP committee published the IPEC Good Distribution Practices Audit Guideline for Pharmaceutical Excipients as another tool to evaluate the practice and quality systems of those parties involved in the supply chain of pharmaceutical excipients (3). The audit guideline provides auditors with a questionnaire containing almost 250 questions that reflect all the elements of the GDP guide. Intended to provide a framework for the auditor who must always decide the scope of an audit, the guideline can also be used as a self-assessment questionnaire to be completed by a distributor or supplier, or as an audit checklist.

IPEC–Europe has used many of the questions from the Safety and Quality Assessment Scheme–SQAS Distributor (ESAD II, primarily section F and subsection G) questionnaire to achieve close harmonization with this document already widely used by European distributors of chemicals (2, 4).

Future directions

By applying the principles of the IPEC GDP guide and audit guideline, along with GMPs, manufacturers and distributors can attain an appropriate level of control at all stages of the manufacturing and distribution process. In addition, the IPEC GDP audit guideline can aid the auditing process when a manufacturer is working with a pharmaceutical excipient distributor.

Looking ahead, the European Commission is working on legislation for identified "certain" pharmaceutical excipients, which may lead to legal enforcement of GDP principles. In the US, IPEC–Americas and the Food and Drug Administration are in discussions regarding the implementation of an excipient pedigree that would require pharmaceutical dosage-form manufacturers to be aware and knowledgeable of the complete supply chain of the excipients they use. Specific requirements are defined in TriPEC's Excipient Pedigree position paper for excipient manufacturers, distributors, and users. There is also an initiative driven by IPEC–Europe and the European Fine Chemicals Group to implement a certification scheme for producers and distributors of pharmaceutical excipients. The scheme will be based on ISO 9001 with additional requirements taken from IPEC's GMP and GDP guides. The final documents will be invaluable to drug manufacturers, distributors, and suppliers who wish to manage risk and ensure their products are safe for the patient.

The Good Distribution Practice (GDP) Committee of the International Pharmaceutical Excipients Council of Europe (IPEC–Europe) consists of the following members: Mathias Brenken at Dow Deutschland, Andreas Lekebusch at Biesterfeld Spezialchemie, Wilhelm Gierling at Brenntag Holding, Steve Hewitt at sanofi-aventis, and Allan Whiston at QA Resolutions, and Frank Milek at Aug. Hedinger, tel. +49 711 402050,


1. WHO Expert Committee on Specifications for Pharmaceutical Preparations, "Annex 2: Good Trade and Distribution Practices for Pharmaceutical Starting Materials," in WHO Tech. Rept. Series, No. 917 (38), 2003.

2. IPEC, IPEC GDP Guide for Pharmaceutical Excipients (2006).

3. IPEC, IPEC GDP Audit Guideline for Pharmaceutical Excipients (2008).

4. CEFIC and FECC, European Single Assessment Document for Chemical Distributors, Appendix B (Brussels, 1999), Rev. 2003, 2006.


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