15.08.2016 |

LOGFILE No. 44/2016 – Managing Contract Maufacturers and Testing Labs

Managing Contract Manufacturers and Testing Labs

An excerpt from the GMP Focus download Managing Contract Manufacturers and Testing Labs

by Dr. Christian Gausepohl, Dr. Frank Böttcher

Selecting a Contract Manufacturer

There can be different reasons for outsourcing manufacturing steps. The selection of a contract manufacturer depends on what the contract giver wants to achieve through outsourcing. The risk potential of outsourcing manufacturing tasks should be identified by the contract giver in advance to ensure that the risks posed by the individual contract manufacturers can be determined during the selection process. When selecting a contract manufacturer, the technological requirements and restrictions are of particular importance.

Here are some questions to ask yourself and potential contractors during the selection process:

  • How long has the company been conducting contract manufacturing?
  • Has the company carried out comparable projects successfully in the past?
  • Does the company have experience in carrying out technology transfers, scale-ups and manufacturing for several different customers?
  • Is the company big enough to manufacture the planned quantities?
  • Is the geographical location of the company suitable in terms of taxes, import/export problems, political stability, etc.?
  • Has the company worked with local regulatory authorities on a previous occasion and does it have relevant contacts, especially in the countries to which the goods will be exported?
  • Does the company have properly trained scientists, engineers and project managers?

Scope of Activities

There are a number of different activities that can be outsourced to a contract manufacturer, including:

  • Manufacture of bulk products;
  • Carrying out of individual process steps;
  • Primary packaging;
  • Secondary packaging;
  • Storage and transport;
  • Distribution;
  • Accompanying analytical testing of processes;
  • Pre-release inspections and stability tests;
  • Batch certification;
  • Manufacture of clinical samples and stability samples; and Managing Contract Manufacturers and Testing Labs, 2016 Edition 5
  • Manufacture of small batches during development and scale-up.

The scope is initially defined based on the current requirements of the contract giver. Additions or changes to services can occur during the working relationship because of:

  • Changes at the contract giver, e.g., changes to the strategy and reasons for outsourcing;
  • Outsourcing of additional areas of competence as a result of positive experience with the contract manufacturer; and
  • Changes in the product life-cycle, e.g., because of a transfer to commercial manufacturing

Definition of Responsibilities

Chapter 7 of the EU GMP Guidelines Part I, Outsourced Activities, clearly specifies the responsibilities of the contract acceptor and the contract giver (see Appendix A). This makes it easier to define the responsibilities in the mandatory contract, and it also helps clarify the expectations of the authorities with regard to the relationship between the contract giver and the contract acceptor.

Contract giver responsibilities specified in Chapter 7 are:

  • Risk-based control system for the manufacturing processes and products (section 7.4);
  • Qualification of the contract manufacturer before outsourcing (section 7.5);
  • Contractual safeguarding of GMP compliance (section 7.5);
  • Provision of all information required by the contract manufacturer (section 7.6);
  • Monitoring and evaluation of the performance of the contract manufacturer and identification and implementation of necessary improvements (section 7.7);
  • Monitoring and evaluation of the protocols and results (section 7.8); and
  • Acquiring QP approval for the delivered products (section 7.8).

Contract manufacturers must be qualified before contract manufacturing begins. Their suitability is checked and evaluated during the supplier qualification. A contractual agreement on the responsibilities of both parties is important in order to avoid risks to the quality of the product or compliance with regulations, for example through uncertainties about the evaluation of deviations during manufacture or about the specific requirements in individual countries. The agreement should focus on the transfer of information and knowledge required by the contract manufacturer to reduce the risk to the quality of the product and to ensure operational safety at the contract acceptor. Examples include critical process-related empirical data as well as material safety data sheets or other safety-relevant information about materials, especially about new active ingredients.

A risk-based monitoring system for the outsourced manufacturing steps and products received must be in place at the beginning of contract manufacturing. The processes that are carried out and the quality of the product must be monitored, and the performance of the contract manufacturer must be evaluated regularly.


The GMP Focus PDF Download Managing Contract Manufacturers and Testing Labs provides you with a step-by-step guidance through all you need to know about

selecting and managing contractors, including:

  • Scope of the contract
  • Responsibilities of both parties
  • Selecting a project team
  • Creating a project plan
  • Change control
  • Procurement
  • Sampling
  • Stability testing
  • Transportation
  • Documentation
  • Communication

Outsourcing laboratory testing and analysis can be especially challenging, but with this report, you’ll know how to:

  • Decide what testing should and should not be outsourced
  • Select a testing laboratory
  • Audit and monitor the laboratory
  • Design effective testing contracts
  • Transfer tests, analytical procedures, microbiological methods and more
  • Handle certificates of analysis


Dr. Christian Gausepohl

Rottendorf Pharma GmbH, Ennigerloh


Frank Böttcher

Laboratory L+S AG, Bad Bocklet/Großenbrach