Certificate of Analysis


Question: Can I use my vendor’s Certificate of Analysis when making a pharmaceutical product or compounding a product as a 503B outsourcing facility?  Yes – BUT in accordance with 21 CFR 211.84(d)(1) and (2):

(d) Samples shall be examined and tested as follows:

(1) At least one test shall be conducted to verify the identity of each component of a drug product. Specific identity tests, if they exist, shall be used.

(2) Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals. [bold added by author]

So as a manufacturer or compounder can you use the vendor Certificate of Analysis – Yes!  However, as the manufacturer who is held to cGMPs and the need to demonstrate adequate control over your product and raw materials you need to verify through independent testing and supplier oversight that you are getting what is represented by the vendor Certificate of Analysis reference 21 CR 211.84.  A slight variation on Mobley’s 3rd Law: you get what you inspect vs what you expect, and of course all of this needs to be properly documented.

FDA has specifically cited firms for failure to exercise this qualty responsibility in multiple warning letters.  For example in the FDA Inspection Summary for FY 2017, 21 CFR 211.84(d)1 and (d)2 were cited a total of 89 times.  21 CFR 211(d)1 was cited 37 times where the identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.  Additionally 21 CFR 211.84(d)(2) was cited a total of 62 times with the following issues identified:

  • Establishment of the reliability of the component supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals. (22 instances)
  • Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals] (22 instances)
  • Specific identification tests are not conducted on components that have been accepted based on the supplier’s report of analysis (8 instances)
  • Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality (6 instances)
  • Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality (4 instances)

Have a question on the design, development, or implementation of supplier quality or incoming inspection practices?  Received an inspection finding concerning the firm’s use of Certificate of Analysis and have a question? If so please contact Dr. Van Doel, or use our Contact Us form and one of Performance Validation’s team will be in touch.

About Performance Validation:  Performance Validation is a 100% employee-owned company has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.

We are not a virtual company, a staffing agency, or a “body shop.”  Our projects are managed and staffed by our own employees. We live by our Mission, which is to provide our clients with peace of mind, and we have been doing so for more than 30 years.