CMOs must communicate issues early to their clients. If in the transfer process there are issues, do not try to solve those
issues without good communication with the sponsor company or third-party laboratory. How often does a written method neglect
the "art" part of the assay that can only be obtained through asking questions or trial and error?
Finally, and most importantly, ensure the timeline links method transfer with critical manufacturing dates. Demonstration
runs and batches are to test quality-control processes and method usage and to validate the compounding and manufacturing
processes. No one wants to be in the situation where the day before manufacturing the in-process test is not ready.
Quality is challenging. When thoughtfully considered and appropriately planned, however, it can actually be a pleasure. Many
actually enjoy the laboratory. From a CMO scientist's perspective, nothing is more gratifying than valid results, successful
filings, passing inspections, product release, and happy customers (CMOs, sponsor companies, and patients). These elements
translate into excellent customer service.
Outsourcing with CMOs is a vital part of the pharmaceutical drug-manufacturing industry. Whether at the clinical-trial stage
or the commercial production stage, sponsor company and CMO relationships are the basis for effective and timely regulatory
filings and successful production.
As stated previously, it takes hard work, considerable organization, preparation, communication, and compromise to ensure
the success of our projects. Companies using the principles reviewed here are those who will enjoy future success.
Sandra Lueken is a senior manager of quality control at Hollister Stier Laboratories, LLC, 3525 North Regal St., Spokane, WA 99207, tel.
509.482.0595, fax 509.484. 4320, Sandra_Lueken@hollister-stier.com