Quality control and quality assurance

Quality control (QC) and quality assurance (QA) in pharma and biopharma manufacturing

QC scientists are under close scrutiny as they work to reduce risk in production, achieve rapid product release, and eliminate defects, impurities and contamination, from raw materials through to finished product - as well as supporting relevant quality assurance (QA) and regulatory standards.

With the industry under pressure because of a general lack of capacity , particularly in the production of biologics, technology is playing an increasingly important role, supporting QC scientists as they implement analytical strategies to ensure that the highest quality standards are reached and maintained. In addition, scrutiny from QA colleagues and industry regulators adds a significant burden. Against this background, instruments that are designed for easy implementation of SOPs in a GMP/GLP/cGMP environment and, where appropriate, the inclusion of IQ/OQ documentation and 21 CFR pt11 compliant software can all help.

Bruker helps QC scientists to manage their workload by providing tools for QC applications that include: microanalysis by FT-IR/Raman microscopy; microbial identification by MALDI-TOF-MS; determining compound identity and quantitation by NMR; raw material analysis by XRD spectrometry; counterfeit analysis by FT-IR spectroscopy; analysis of APIs by LC-MS.