Is it Permissible to Use Analysis Results From External Laboratories?

22.07.2024

LOGFILE Feature

Excerpt from GMP Fundamentals, Chapter 9.C

5 min. reading time | by Christine Oechslein, PhD
Published in LOGFILE 16/2024

Carrying out quality testing internally may be a complex process, but it also has many advantages. A solid knowledge of product properties, stability and degradation products is built up over time in a laboratory and can be particularly valuable when carrying out quality risk analysis. However, some tests can be outsourced to external partners.

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.

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de

Christine Oechslein Written on 22 July 2024

You may also be interested in the following articles:

24.11.2025

Question of the Week

How is a QRM process initiated?

You can view the answer here:

FDA: Updated Pre-RFD Guidance for Combination Products

The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.

Related Products

GMP Compliance Adviser | Named User Licence | 12M

The GMP Compliance Adviser is an online publication that covers all aspects of Good Manufacturing Practice (GMP) in one source.In the GMP Compliance Adviser you’ll find: GMP in Practice This part contains 21 chapters with GMP expert knowledge to base your decisions upon. It provides practical assistance with checklists, templates and SOP examples. It is written by more than 80 authors with hands-on experience directly linked to the industry. The individual chapters describe the different aspects of GMP in clear language. Technical, organizational and procedural aspects are covered.More than 700 checklists, templates and examples of standard operation procedures taken directly out of practice help you in understanding the GMP requirements.GMP RegulationsThese chapters cover the most important GMP regulations from Europe and the United States (CFR and FDA), but also PIC/S, ICH, WHO and many more. Sample Documents In addition, the GMP Compliance Adviser contains many sample documents and practical examples that you can use.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€1,335.00 net excl. VAT

Details

GMP:KnowHow Pharma Logistics (GDP) | Named User License | 12M

Your knowledge base about GDP-compliant handling of your pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, adhere precisely to the regulatory requirements. The GMP:KnowHow knowledge portal guides you through the regulatory jungle of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Using graphics, you can easily navigate through all the areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves you a lot of time on time-consuming searches and research!One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? The GMP:KnowHow Pharma Logistics (GDP) is your guideline for Good Distribution Practice. It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante – now Director Quality at Fisher Clinical Services – was previously Head of Quality Control and Responsible Person according to GDP (VP) for the entire Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€610.00 net excl. VAT

Details

E-Learning GMP:READY | GMP for Engineers Online Course

Why are GMP rules important for technicians and engineers? Technicians and engineers play a key role in ensuring compliance with Good Manufacturing Practice (GMP) standards. They are involved in critical activities such as: planning and construction of ventilation systems, maintenance of water treatment plants, calibration of measuring sensors. Therefore, they are jointly responsible for the quality of medicines and must ensure that their work complies with GMP standards.Your advantages: Fast familiarization with GMP topics in approx. 2 hours, time- and location-independent online training, printable personal certificate, 12-month access for initial and follow-up training, automatic updates in case of legal changes, content compliant with Article 7(4) of Directive 2003/94/EC.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€240.00 net excl. VAT

Details

GMP Fundamentals | A Step-by-Step Guide

This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previously acquired knowledge. Some topics are: GMP: Purpose and basic pharmaceutical terms Laws, licenses and inspections Personnel: Responsibility and hygiene Standard Operating Procedures (SOP) and documentation Design of rooms and facilities Processing and packaging Quality control and market release Suppliers, storage and logistics (Good Distribution Practice = GDP) Alphabetical index and abbreviations Using practical examples and comparisons to every-day life will help to easy understand GMP regulations.GMP Fundamentals is a helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.

Ready for dispatch, delivery immediately after receipt of payment

€44.90 net excl. VAT

Details