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Pharmaceutical manufacturers may seek independent third-party facilities for testing because they believe that a supplier-affiliated laboratory, potentially having a conflict of interest, might skew the testing results in favor of a particular product. People are naturally suspicious of claims made from a source they may perceive as biased.
However, when making a selection between an independent or supplier-affiliated lab, a logical, data-driven selection process, rather than a process based on unsupported preconceptions, is most likely to yield the best results. First, look for the facility with personnel having the most knowledge and experience in the type of testing required. Such a choice will be a wise investment because the knowledge base can help to provide answers with speed and accuracy. For example, a laboratory with a deep understanding of the parenteral closure manufacturing process will likely bring a unknown particle investigation to a close more quickly if the scientists working on the investigation have experience and knowledge of what could reasonably be there in the first place.
Second, look for an FDA-registered facility with an unquestioned reputation for quality and integrity. An FDA-registered laboratory operates under the assumption that the FDA could walk in the door at any time and request the data generated on behalf of a drug application. Accordingly, an FDA-registered facility should be adhering to all applicable agency regulations and will have safeguards in place to ensure data is reported accurately.
Whether the final choice is an independent or supplier-affiliated laboratory, pharmaceutical manufacturers who follow these guidelines will help ensure that their selection is the laboratory most qualified for the job.
West Analytical Services provides the specialized testing required for drug product method development, validation, release, stability, administration systems, devices and packaging testing.