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Biocidal products manufactured in or imported into the EU or European Economic Area must be authorised for compliance with the requirements of the EU Biocidal Products Regulation (BPR) and any relevant national legislation before being placed on the market.
The process of manufacturing a biotherapeutic drug entails numerous quality control measures to ensure safety and efficacy. The articles in this in-depth focus discuss higher order structure analysis and host cell protein contamination issues.
The latest research and developments from Pharma and Biopharma industry experts.
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
The FDA has told its staff that it will be assigning drug compounding to the Office of Compliance.
In this paper the suitability of reagent water for LC-MS biomedical analyses will be evaluated and the role of water quality in achieving sensitive and reliable LC-MS analyses will be discussed.
Having a holistic data infrastructure in place can not only save time by providing key real-time information and money through readily-accessible, enterprise-wide intelligence, it can also ensure stress-free operations.
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.
The company has announced a recall of products which were intended to be sterile after a lack of sterility assurance.
A multi-company system to improve traceability of pharmaceutical products is newly supported by the FDA.
Although good auditors base conclusions on facts, emotions will play an important part in how they perceive your company, your leadership and your quality culture.
In this issue we explore reasons behind critical key drug shortages in the EU, whether viability methods effectively detect all viable organisms and how companies can future-proof their digital technologies ahead of Brexit. Also included are articles on higher order protein structure, FMD compliance and Raman spectroscopy.
Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules –impact of dissolution rate on bioequivalence.
ISO/IEC 17025:2017, general requirements for the competence of testing and calibration laboratories, is the international reference for laboratories carrying out calibration and testing activities around the world.
A drug alert has been issued for two batches of paracetamol tablets found to have discolourations due to fungi.
