Excipient Pedigree Verification - Pharmaceutical Technology

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PharmTech Europe

Excipient Pedigree Verification
The author explains the background behind the excipient pedigree and how to implement its use.

Pharmaceutical Technology
pp. s28-s31

Packaging and labeling

A secure supply chain can be achieved when all parties are confirmed to be in compliance with excipient GMP and GDP requirements. It is also crucial to establish procedures to ensure the quality of the excipient upon receipt. Current industry practice for approving/accepting an excipient from a qualified supplier is to confirm the quality of the excipient based on the CoA and identification testing. Industry best practice is to expand this approach to include confirmation that the excipient has not been tampered with at any stage of its distribution cycle.

A tamper-evident seal for each excipient package can help provide such assurance. However the individual responsible for receiving an excipient often must deal with different seals because each supplier should use a unique seal. An authentic photograph from each excipient supplier showing the tamper-evident seal should be available to the receiver so that he can confirm that the package's original seal has remained in place while en-route. Authentic photographs of both the excipient package and label can provide additional assurance that the excipient was not repackaged.

Overall, receipt of excipients involves satisfactory completion of the following steps:

1. Confirmation according to shipping papers that the excipient came from the approved supplier

2. Verification that the package has not been tampered with by comparing the package and its seal with authentic photographs and packaging descriptions. This step includes determining whether:

a. The excipient was received in the approved packaging (contact packaging and secondary containers)

b. The authentic tamper-evident seal is in place

c. The authentic label is in place.

3. Scientifically justified sampling of the excipient packages and confirmation that the excipient passes appropriate identification testing.

4. Verification that the CoA demonstrates that the excipient meets the compendial monograph or appropriate specification.

Periodically, the pharmaceutical user also should verify that the qualified supplier produced the excipient and that the CoA is authentic. Confirmation of the manufacturer can be accomplished by using shipping papers to trace the supply chain. CoA authentication can be achieved by sending the CoA to the excipient manufacturer to verify that it is unaltered.


Recent incidents have sensitized the pharmaceutical industry to economically motivated adulteration and excipient vulnerability. Many presentations and papers have addressed supply-chain security, but the practice of receiving and approving excipients must be strengthened to fully ensure drug product safety.

Irwin Silverstein is vice-president and chief operating officer of International Pharmaceutical Excipients Auditing (IPEA), a subsidiary of the International Pharmaceutical Excipients Council (IPEC), tel. 732.463.8710,
, http://www.ipeainc.com/.


1. A.J. Falk, Pharm. Technol. 34 (3), 78-70 (2010).

2. IPEC–PQG, Joint IPEC–PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (2005).

3. IPEC, Good Distribution Practices Guide for Pharmaceutical Excipients (2006).

4. B. Hasselbalch, "Public Health Challenges for the Quality of Human Drugs," presented at FDA–Xavier University Global Outsourcing Conference (Cincinati, June 2010).


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