11.06.2019 | LOGFILE Feature 22/2019

An excerpt from the GMP Compliance Adviser, Chapter 17.B.4

Outsourcing: How to Assign a Contract Laboratory

Outsourcing: How to Assign a Contract Laboratory

5 min. reading time | by Frank Boettcher


Apart from the statutory requirements that must be observed, commercial aspects and corporate policy also have a role to play when selecting a contract laboratory.

The Internet is normally used to find a suitable laboratory. Associations and private organisations also provide an overview of service providers working in the pharmaceutical industry.

The laboratory must meet the statutory requirements that apply to medicinal products and have the expertise to carry out the tests using state-of-the-art science and technology. The testing expertise required can be assumed in cases where the laboratory was involved in the development of the test method.

If tests are outsourced to an external provider after they have been developed in-house, the expert knowledge must be shared with the provider. Therefore, the contract giver must ensure that their expertise is protected and is only used for the tests ordered.

On the other hand, the contract giver must develop a secure and sustainable relationship with the contract laboratory so that they can rely on the services of the laboratory. It is important that a situation does not occur whereby the contract giver can no longer sell their product because one or more tests can no longer be carried out externally. This includes ensuring that tests are outsourced to contract acceptors who are economically "sound" and are definitely in a position to offer the required capacities on an ongoing basis.

A mutual non-disclosure agreement is normally signed by both parties prior to contracting to protect the expert knowledge on both sides. Economic terms and conditions such as rates, terms of payment, liability issues and notice periods can be agreed in commercial agreements. Quality considerations and economic factors must be taken into account when work is outsourced to external service providers. It therefore makes sense to involve the different departments at the very start of the selection process, i.e. Quality Assurance, Quality Control or Head of QC, the Qualified Person, if necessary, and the purchasing department.

The questions listed in Figure 1 should be addressed when carrying out a suitability test for an external testing laboratory. The professional competence of the laboratory can be assessed by third-party certification of the contract laboratory, e.g. manufacturing licence, GMP certification and accreditation, by inspection reports of other pharmaceutical companies or by its level of active participation in committees and organisations as well as scientific contributions made and involvement in projects where an expert opinion was given.

Figure 1 Criteria for the selection of an external laboratory

The outsourcing of testing to a contract laboratory inevitably leads to more complex procedures; the procedures at the interfaces between the contract giver and contract acceptor alone must be accurately controlled. For this reason, outsourcing must be carefully planned and implemented according to the plan. Several actions are necessary, from the selection of potential contract laboratories to the actual commissioning of the tests. They are listed in Figure 2.

Figure 2 Course of precurement

The sequence of individual steps can vary. Tests which affect the release of medicinal products may only be commissioned when the supplier is properly qualified, the test method is transferred to the contract laboratory and a service or quality agreement is signed.

Laboratories that are shortlisted after a general suitability test because of the range of services that they offer must be checked to see if they can carry out the tests in accordance with the statutory requirements for medicinal products.

It must first be checked to see if the laboratory is suitable for carrying out contract analysis. This includes a number of different aspects. A number of suitability criteria must be met due to statutory requirements, others are desirable because they ensure that simple outsourcing processes can be used or that less involvement of the contract giver is required (cf. Figure 1).

It is useful to request the site master file from the laboratory for the first suitability test. This document describes how the contract laboratory is going to meet the requirements of the EU GMP Guidelines.

This text is an excerpt from the GMP Compliance Adviser, Chapter 17.B.4

Frank Böttcher


Frank Böttcher, PhD
Managing Director and Qualified Person at HWI pharma services GmbH
E-Mail: f.boettcher@hwi-group.de
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