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Quality Assurance (QA) covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. This article focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines.
This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.
Specifications are defined as “a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described”.1
In this Spotlight on Manufacturing, ACG explains how it meets clients’ changing needs and identifies emerging market trends...
In this Spotlight on Single Use, David Beattie, Vice President BioProcessing R&D, Merck explains the mode of operation and benefits of its Pellicon® Capsules...
Even with the rise of rapid microbiological methods, most environmental monitoring applications are undertaken using culture media, with many alternative methods also being growth-based. This makes the selection, control and release of culture media an area of great importance, given that the quality of the culture media underpins the environmental…
Pharmaceutical products come into contact with a wide range of polymeric materials on their journey from the production line to patients. Plastic and rubber contact surfaces are present at almost every stage of a product’s lifecycle: they’re present in single-use systems, such as filters and tubing employed in manufacturing processes;…
In this issue: Anastasia Petropoulu focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines, and Dave Elder looks at method/process capability in terms of QA/QC.
In this issue: the importance of culture media selection, control and realease, how the new draft of Annex 1, Manufacture of Sterile Medicinal Products is impacting environmental monitoring programmes, and software tools that enable confident GC-MS analysis of extractables in pharmaceutical products.
In this issue: investment in biopharmaceuticals, particle size methods, and unlocking the potential of new technologies like Lab-on-a-chip.
A US perspective on how pharma companies are preparing for Brexit, overcoming disinfectant residues with culture media neutralisers, unlocking the potential of new technology in biopharma, and much more in this issue of European Pharmaceutical Review.
More guidance is needed on the appropriate control of non-mutagenic impurities during clinical development, explains Dave P Elder, JPAG Member and pharmaceutical industry consultant, in this audio interview.
As part of EPR’s Women inspiring Pharma series, Gowri Sukumar, Associate Director, CMC and Regulatory Affairs at ESSA Pharmaceuticals, talks to Science Editor Dr Zara Kassam about having a positive mindset, diversity and the key to success…
This supplement brings together leading companies with compelling science stories to share in a simple-to-understand format.
This issue recaps the Joint Pharmaceutical Analysis Group's symposium on Continuous Manufacturing, and explores the "perfect technology storm" facing the pharmaceutical sector.
