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, fmilek@hedinger.de
References
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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