news
Premier Pharmacy Labs recalls products after FDA inspection
The company has announced a recall of products which were intended to be sterile after a lack of sterility assurance.
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FDA joins blockchain system for drug safety
A multi-company system to improve traceability of pharmaceutical products is newly supported by the FDA.
whitepaper
Whitepaper: How to write to regulatory agencies when things go wrong: your essential guidance
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.
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European Pharmaceutical Review Issue 3 2019
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.
whitepaper
Whitepaper: Good as gold: Capsugel®, Vcaps® Plus capsules
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.
whitepaper
Whitepaper: Achieving & maintaining ISO 17025:2017 accreditation with LIMS support
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.
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MHRA issues recall of paracetamol tablets
A drug alert has been issued for two batches of paracetamol tablets found to have discolourations due to fungi.
whitepaper
Case study: Challenges in day-to-day operations: The battle of performance in production
How an inline vial management device is able to reject, retrieve for sampling, or reintroduce vials automatically during the loading/unloading process into pharmaceutical freeze-dryers.
video
IonBench: Manufacturer of mobile benches for mass spectrometry and liquid chromatography
Overview on how ionBench products can help LC/MS users with dedicated furniture for their instrumentation
news
Amyloidosis treatment discontinued from clinical trials
A treatment for amyloidosis has been pulled from clinical trials after failing to reach endpoints.
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NICE recommends Prevymis on the NHS after re-evaluation
The National Institute for Health and Care Excellence is recommending MSD’s Prevymis (letermovir) within the NHS.
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New partnership established to track drugs using blockchain
Walmart has joined a consortium that’s attempting to build a blockchain for tracking pharmaceutical supply chains.
news
Heritage announces product recall after sterility test failure
Heritage has recalled two of its injectable treatments after microbial growths were found.
news
First PI3K inhibitor for breast cancer approved by FDA
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
news
FDA sends warning letter to Canadian OTC manufacturer
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).
