Certificates of Analysis: Don’t Trust, Verify

Just found this article on pharmtech.com with the introduction


„Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.“ 


and thought there might be some interesting facts, basis to learn and discuss.


Certificates of analysis (CoAs) are a tangible, and important, manifestation of a manufacturer’s relationship with its suppliers of APIs, excipients, and the other materials used to make drug products. Provided by suppliers to customers as a matter of course, these documents operate at the point where materials, laboratory control systems, and manufacturing intersect. These are three of the six crucial domains governed by any good pharmaceutical quality system (1). The right approach to managing and evaluating CoAs is also key to maintaining data integrity, an area where many pharma company compliance strategies continue to fall short (2).


CoAs summarize key information on product quality testing, including test conditions and parameters, specifications and requirements, results of tests (both qualitative and quantitative), and approval signature and date. They also provide information on the chain of custody, including such basics as the manufacturer’s name, address, telephone number/email and other identifiers that allow the material to be tracked throughout the supply chain.


Despite CoAs’ importance, some pharmaceutical manufacturers have begun to take them for granted. In other cases, they may be relying on them too much. As spectroscopist and consultant Emil Ciurczak notes, “They might be better off heeding the old Russian proverb: ‘Trust, but verify,’ which former US President Ronald Reagan often used in arms control talks with the former Soviet Union.”


In fact, given the complexity of outsourcing chains today, taking a defensive approach, and cutting straight to “verify” might be an even better strategy.  Ciurczak recommends taking a systematic approach and, in addition to thoroughly testing all incoming materials, randomly testing APIs a second time, on a rotating basis, to validate data in the CoAs.


In general, many pharma companies don’t do a good job in their annual verification of supplier CoAs, notes Irwin Silverstein, consultant to the International Pharmaceutical Excipients Council (IPEC).  “Their focus seems to be only on whether the sample they test annually meets the monograph. They should instead investigate any measurements that differ significantly from what was reported on the CoA. These differences may be due to differences in test method or sample preparation, lack of homogeneity within the excipient lot, or erroneous test results,” he says.


“Best practice would be to make CoA verification part of annual overall verification. It would require sending the excipient manufacturer a copy of the CoA they have received and asking whether their copy is genuine,” Silverstein says. In addition, manufacturers should review the CoA with attention to the reference to the test method. Where the method listed is not compendial, they should request a copy from the manufacturer, says Silverstein.


Apr 02, 2018 By Agnes Shanley

Pharmaceutical Technology – Volume 42, Issue 4


Apr 02, 2018
By Agnes Shanley
Pharmaceutical Technology
Volume 42, Issue 4, pg 60, 64, 66, 69
Certificates of Analysis: Don’t Trust, V
Adobe Acrobat Document 97.0 KB

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