GMP Requirements for Certificates of Analysis (CoA)
At times of outsourcing and globalisation, the significance of Certificates of Analysis (CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy and completeness.
There are CoAs for excipients, APIs, packaging materials and finished products. A closer look at the guidelines shows that there are a few regulatory requirements which are often unknown.
A certificate of analysis is prepared for each batch of a substance or product and usually contains the following information:
(a) the registration number of the sample;
(b) date of receipt;
(c) the name and address of the laboratory testing the sample;
(d) the name and address of the originator of the request for analysis;
(e) the name, description and batch number of the sample where appropriate;
(f) the name and address of the original manufacturer and, if applicable, those of the repacker and/or trader;
(g) the reference to the specification used for testing the sample;
(h) the results of all tests performed (mean and standard deviation, if applicable) with the prescribed limits;
(i) a conclusion as to whether or not the sample was found to be within the limits of the specification;
(j) expiry date or retest date if applicable;
(k) date on which the test(s) was (were) completed; and
(l) the signature of the head of laboratory or other authorized person.
Content of the Analytical Test Report
The analytical test report should provide the following information:
(a) the laboratory registration number of the sample;
(b) the laboratory test report number;
(c) the name and address of the laboratory testing the sample;
(d) the name and address of the originator of the request for analysis;
(e) the name, description and batch number of the sample, where appropriate;
(f) an introduction giving the background to and the purpose of the investigation;
(g) a reference to the specifications used for testing the sample or a detailed description of the procedures employed (sample for investigative testing), including the limits;
(h) the results of all the tests performed or the numerical results with the standard deviation of all the tests performed (if applicable); a discussion of the results obtained;
(j) a conclusion as to whether or not the sample(s) was (were) found to be within the limits of the specifications used, or for a sample for investigative testing, the substance(s) or ingredient(s) identified;
(k) the date on which the test(s) was (were) completed;
(l) the signature of the head of the laboratory or authorized person;
(m) the name and address of the original manufacturer and, if applicable, those of the repacker and/or trader;
(n) whether or not the sample(s) complies (comply) with the requirements;
(o) the date on which the sample was received;
(p) the expiry date or retest date, if applicable; and
(q) a statement indicating that the analytical test report, or any portion thereof, cannot be reproduced without the authorization of the laboratory.
Requirements can be found in the following sets of rules:
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EU GMP Guide Part I (Chapter 4 and Chapter 6)
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EU GMP Guide Part II – Section 11.4
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EMA Guideline on batch certification (Internationally harmonised Requirements for Batch Certification)
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WHO Annex 10 – Model Certificate of Analysis
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USP General Chapter <1080> Bulk Pharmaceutical Excipients – CoA
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IPEC CoA Guide for Pharmaceutical Excipients