WHO TRS (Technical Report Series) 1010, 2018 Annex 4


WHO TRS (Technical Report Series) 1010, 2018 Annex 4

Model certificate of analysis

It has been recommended in various forums that the World Health Organization (WHO) should establish a model certificate of analysis (CoA) for use by quality control laboratories (QCLs) and in trade in starting materials and finished pharmaceutical products (FPPs). The model for such a certificate was first published in 2002 (1) and the current model is shown in Appendix 1. The items included are based on WHO good practices for pharmaceutical quality control laboratories (2) and WHO good manufacturing practices for pharmaceutical products (3). In addition, requirements of the International Standard ISO/IEC 17025 (4) and recommendations of the International Pharmaceutical Excipients Council (5) have been taken into account. Any specific legal requirements existing in the country of issue or importation should also be considered when issuing the certificate. This guidance is essentially designed for QCLs not related to manufacturers since the QCLs of manufacturers may have some of the information listed below in other quality system documents and therefore not necessarily included in the CoA.

The format and organization of the information on the CoA is at the issuing laboratory’s discretion. The CoA can be printed on letterhead with the logo of the issuing laboratory. According to WHO good practices for pharmaceutical quality control laboratories (2) the CoA lists tests performed on a particular sample with the results obtained and the acceptance criteria applied, followed by an indication of whether or not the sample complies with the specification. A CoA is usually prepared for each batch of a substance or product and should include the following information:

– the name and address of the laboratory issuing the CoA;

– the identification number of the CoA and on each page an identification, the page number and the total number of pages to ensure that every page is recognized as a part of the certificate;

– the name, address and contact person representing the originator of the request for analysis;

– the number assigned to the sample by the laboratory during registration upon receipt;

– the date on which the sample was received in the laboratory and the quantity of sample (number of units or packages);

– the name, description (for example, active ingredient, dosage form, strength, package size in the case of FPPs; grade in the case of starting materials; type and material of the primary packaging), batch number (used by the original manufacturer and repacker or trader) of the sample for which the certificate is issued, the expiry date (or retest date, where applicable) and date of manufacture (if available);

– the name and address of the original manufacturer; in addition, if supplied by repackers or traders, the certificate should show the name and address of the repacker or trader;

– specifications for testing and a reference to the test procedure(s) used, including the acceptance criteria (limits);

– the results of all tests performed on the sample for which the certificate is issued (in numerical form, where applicable) and a comparison with the established acceptance criteria (limits); results of tests performed by subcontractors should be identified as such;

– any comments, observations or information on specific test conditions, where these are necessary for the interpretation of the results;

– a conclusion as to whether or not the sample was found to be within the limits of the specification;

– the date and signature of the head of the laboratory or other authorized person approving the certificate.

If the sampling plan and procedures used by the laboratory or other bodies are relevant to the validity or interpretation of the results, they should be referenced in the CoA.

Where relevant to the validity or application of the results, or if required by a customer, a statement on the estimated uncertainty of measurement should be included. However, it should be borne in mind that pharmacopoeial content limits are set taking into account the uncertainty of measurement and the production capability, and acceptance criteria for an analytical result should be predefined. Under currently applicable rules, neither the pharmacopoeias nor the medicines regulatory authorities require the value found to be expressed with its associated expanded uncertainty for compliance testing.

In the case of testing under contract, a customer may also request other information to be specified in the CoA.

If appropriate, the CoA may include a photograph(s) of the packaging and/or product tested.

If new certificates are issued by or on behalf of repackers or traders, these certificates should show the name and address of the laboratory that performed the tests and the name and address of the original manufacturer. A copy of the CoA generated by the original manufacturer should be attached.

When the certificate is used in trade it may also include a statement of the expected conditions for shipping, packaging, storage and distribution, deviation from which would invalidate the certificate.

QCLs with accreditation to the International Standard ISO/IEC 17025 should include in the CoA a reference to the accreditation, if related to the specific analysis.

See pdf file for complete details:

WHO TRS (Technical Report Series) 1010, 2018 Annex 4:


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