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Transdermal delivery systems are combination products composed of multiple layers of polymer films designed to deliver a drug through the skin. Due to the complexity of design and the unique dosing regimen, evaluating extractables and leachables from a transdermal delivery system can be challenging. A draft guidance has been issued by the FDA that covers the E&L for transdermal and topical delivery systems . The experimental approach presented in this white paper represents a rational experimental approach to E&L testing of transdermal delivery systems that will satisfy FDA expectations.
To support the growing field of microbiome research, Pine Lake Laboratories has developed an assay for short chain fatty acids (acetic, butyric, and propionic acid) in human plasma. These targeted metabolites can be used as an indicator of microbiome activity in research subjects and as biomarkers to evaluate the effect of various pharmaceutical drug treatments during clinical trials. The assay uses GC-MS and can reach an LOQ of 1.00 ug/mL. for each short chain fatty acid.
Combining a surgical implant with antibiotics will present unique analytical challenges. Most notably, the combining process will likely introduce impurities and degradants not encountered in the various drug product formulations of the antibiotics. In addition, the surgical implant may have design features that need to be measured to ensure proper release of the antibiotics.
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Why are you writing a Business Continuity Plan (BCP)?
In our case, a client auditor reviewing our quality systems for cGMP compliance noted that while we had SOPs in place on Disaster Recovery, Backup Power Generation, Preservation of Raw Data, Safety and others to deal with adverse events that can disrupt the business of the laboratory, we did not have a formal BCP. It was to meet our client’s expectations, not to comply with the cGMPs, GLPs or ISO standards, that we wrote the BCP.
In the process, we learned that the BCP, to be more than a document, has to be part of a Businesvs Continuity Management (BCM) system. The BCM system supports the plan and fosters its continual improvement.