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As a single-source supplier of equipment solutions for the primary packaging of injectable drugs, Steriline develops, manufactures and supplies a comprehensive range of solutions, including both mechanical and robotic applications for the aseptic processing.
This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
An important step in the research and development of biopharmaceuticals is to identify molecules with favourable physical and chemical stability profiles. Yongchao Su, Wei Xu and Bruce Yu discuss how solution, solid-state and benchtop nuclear magnetic resonance (NMR) methods can provide advanced biophysical characterisations of biological products.
Appropriate standards for impurity tests are an important part of analytical testing. In this paper, Kevin Williams outlines various requirements of standards for endotoxin, as stated by United States Pharmacopeia (USP), and elaborates on the definition of endotoxin as distinct from other cellular constituents.
With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.
14 May 2019 | By Abbott Informatics
Understand the role of data integrity in current good manufacturing practice for drugs as required in 21 CFR parts 210, 211, and 212.
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
From starting materials through to finished product testing, Eurofins BioPharma Product Testing’s 34 facilities in 17 countries deliver a comprehensive scope of harmonised GMP testing services and seamless regulatory acceptance.
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
Wickham Laboratories Ltd, backed by five decades of global experience in GMP/GLP-regulated laboratory services, is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy.
This whitepaper serves to illustrate the reasons for exaggerating the extracted surface area to extraction solution volume ratios as is the practice in extractables studies.
The work of a pharmaceutical scientist requires precision, attention to detail and is of vital importance to the safety of products and ultimately patients. This section features insights from experienced scientists who’ve worked extensively in microbiological analysis, developing tests, methods and standards that help establish a foundation for the production…
Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.
Microplate-based standard endotoxin tests require time-consuming manual handling steps, the results of which are by no means conclusive. Read how the GO PLATE - part of ENDOZYME II GO - helps to address these issues.
Modernisation of microbiological test methods involves far more than just the science. As new systems and technologies become available it becomes increasingly important that potential users can identify not only the technical requirements, but also the business case. Here, Paul Newby, Alice Laures and Lisa Wysocki from GlaxoSmithKline discuss criteria…
