Outsourcing Laboratory Work—Establishing the Necessary Policies and Practices - The outsourced service provider should be considered as an extension of your own laboratory. - BioPharm

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Outsourcing Laboratory Work—Establishing the Necessary Policies and Practices
The outsourced service provider should be considered as an extension of your own laboratory.


BioPharm International Supplements


Outsourcing can provide a laboratory with an expanded range of options and tools to conduct its work. Those options can reduce operating costs, allow a laboratory to take advantage of techniques that might not otherwise be available, cross-check results, handle an unusual surge in samples, and develop automation systems. This is particularly true for laboratories that provide analytical or physical property testing support for process development or quality control.

To use outside services effectively, the laboratory must understand the way it functions and how it will manage the outsourced services and the results of its work. Whether the outsourced company provides testing, method development support, or hardware and software systems design and implementation, it should be considered as an extension of a laboratory.

In a regulated environment, the laboratory is responsible for the quality and conduct of its suppliers. The contract service organization is in effect a virtual laboratory, subject to all of the requirements that your laboratory has to meet, including validation and regulatory requirements. This article discusses some of the considerations in outsourcing laboratory testing, method development, and the design of automation systems.

Outsourcing Testing Operations

In many respects, testing operations are similar to manufacturing operations. Samples are processed according to well-defined procedures, and information (e.g., test results, the end product of a testing laboratory's work) are recorded and sent to the customer (R&D, process development, process control, etc.). Thinking about a laboratory in that sense allows us to model outsourcing operations in much the same way a manufacturing plant outsources parts of its operations, with the same considerations for quality management and regulatory issues.

When selecting an outside laboratory to conduct analytical tests, the following need to be considered:

1. Does the contract laboratory have experience with the types of materials and test methods it will be using?

2. How will you ensure confidentially of test methods and the results of the work?

3. How will the laboratory's employees be trained to handle your project?

4. What procedures will be put in place to check the quality of work? How will discrepancies be addressed?

5. What validation protocol will be used to support the outsourcing program?

6. What equipment will be used to conduct the testing?

7. How will the results of the work be reported? What formats will be used?


Figure 1. A test procedure of an assay using liquid chromatography
The first five questions mentioned above should be outlined in the contract between your laboratory and the provider. The final two items are not as easily defined because they rely on automated systems for data acquisition and analysis. For example, let's assume that the test procedure is an assay using liquid chromatography (Figure 1). The instrument is connected to a data station that acquires, processes, and stores the data in a laboratory information management system (LIMS). Your laboratory's systems are from XYZ company, and the format of the data in the data station is unique to XYZ as are the methods used to analyze the data. If you and the contract service organization use incompatible equipment, your test results data also will be incompatible. It may not be possible to reevaluate results from the acquired data and you may have to repeat the analysis, unless manual calculations from reported peak parameters are acceptable. Having an agreement with the contractor to maintain the data on its systems and provide you with a copy can mitigate this situation. Keep in mind, however, that the data lifecycle may be decades, and you can't be sure that the contractor will be in business that long or that its archiving systems are adequate.


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