Is it Permissible to Use Analysis Results From External Laboratories?

Certificates of analysis

A certificate of analysis (CoA) is a summary of the test results. It must contain the name and batch name of the tested product or material, the exact measured values, the test method used and an evaluation of whether the tested material complies with the relevant specification.

Certificates of analysis must be signed by a responsible person to ensure that they are authentic. If a validated computer system ensures that only authorised persons can create certificates, the certificate does not require a signature. Certificates of analysis do not proof that the tested material has been manufactured in compliance with GMP, and they should not be confused with batch certificates. Whether a certificate of analysis that is delivered with a material can replace a test in the company's laboratory depends on whether the party issuing the certificate has been qualified as a contractual partner. During this qualification, the thoroughness of the analyses carried out must be checked and the trustworthiness of the certificates of analysis.

Contract laboratories

Special tests that are only carried out occasionally or require complex equipment are often outsourced to external contract laboratories. It makes sense, for example, to outsource microbiological tests to experts specialising in this field. However, the responsibility remains with the contract giver who must ensure that the service provider has the required expertise before ordering the first analysis. In addition, the responsibilities of the contract giver and the contract acceptor must be contractually agreed (liability limitation agreement, LLA). All contract laboratories must be listed in the site master file of the contract giver.

Method transfer

If two analysis laboratories carry out the same tests, the results are not always identical. If an analysis is to be conducted at a different company site or outsourced to a contract laboratory, the results can be surprising. Although each of the parties has qualified staff and uses qualified equipment, the devil is often in the detail.

To ensure that two laboratories provide matching test results, a formal method transfer must be carried out. The laboratory carrying out the tasks does not only receive comprehensive information on test methods, validation of methods, specifications, reference standards, stability data and safety precautions (material safety data sheets, MSDS), but also agrees to conduct comparison analyses specified in a transfer protocol. It is also possible to repeat parts of the method validation or to carry them out jointly (co-validation).

The contract laboratory can start using the method for GMP analyses after successful completion of the comparison analyses and after both laboratories have approved the transfer report.