Subscribe to our white papers to get the industries latest news.
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.
Please Fill Out Our Form To Receive The Full White Page.
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.
During manufacturing, medical devices are exposed to a wide range of processing agents and materials. Depending upon the medical device, residual levels of these processing agents and materials pose a potential toxicological risk to patients. Therefore manufacturers of medical devices need to identify and properly control for contamination of the medical device from processing agents and materials encountered during the manufacturing of the device. This is done by validation of the cleaning of the medical device.
Please Fill Out Form To Receive The Full White Page Download.