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When choosing a resource for laboratory testing, pharmaceutical manufacturers face a difficult decision. Which is the better option – an independent facility or a supplier-affiliated laboratory?
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.
Need immediate shipping of stoppers or seals? West has an efficient niche operation for small quantity fulfillment: our facility in Lititz, Pennsylvania. For those seeking samples, small quantity fulfillment for research and development needs or just a few components, Lititz offers off the shelf, convenient, fast and friendly customer service.
At West, we are committed to attracting and retaining a diverse and inclusive workforce. We understand that diversity is key to our success and know that a diverse workforce leads to greater innovation, more opportunities, better access to talent and stronger business performance. We encourage a culture of mutual respect, where everyone feels valued and respected and can bring their authentic self to work every day, helping to foster an environment that enables our team members to stay energized, focused and committed to doing their best.
<span style="color: #151515;">Each year in Denmark, approximately 160 children under the age of 14 are diagnosed with cancer. The diagnosis is life changing in many ways for the child and his or her family. Little things that were once taken for granted, like going to the movies or the zoo, may no longer be possible. Often, families are isolated for long periods of time due to a sick child’s weakened immune system.</span>
Natural Rubber Latex (NRL) has been a topic of concern in the pharmaceutical industry since the early 1990s. Concerns with allergens prompted labeling guidelines to ensure safe patient treatment. West Pharmaceutical Services’ elastomeric formulations for injectable packaging components for vials and syringes may contain Dry Natural Rubber (DNR) in the form of crepe, but the formulations do not incorporate NRL.
The future is now for parenteral pharmaceutical and biopharmaceutical sterile production. Traditional high-volume automated aseptic filling suites are maintained by contract filling services. But what’s emerging? Parenteral pharmaceutical and biopharmaceutical industries have transitioned to fully enclosed, isolator/restricted access barrier (RAB) systems. These small, efficient systems offer cost savings and can reduce the potential for particulate and microbial ingress during aseptic fill/finish manufacturing by eliminating direct human contact in the filling environment.
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