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Exploring data integrity guideline changes moving into 2020
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
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FDA sends warning letter to KVK-Tech manufacturing facility
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
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India to hold pharma companies responsible for drug quality after reforms
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.
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Pharma industry calls for GMP agreement between EU and UK
EFPIA, Medicines for Europe and AESGP have called for a Mutual Recognition Agreement on good manufacturing practice in regards to the future relationship between the UK and the EU.
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EMA announces launch of collaborative pilot scheme to inspect manufacturers
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
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Astellas enters into definitive agreement to acquire Audentes Therapeutics
Astellas has announced that it will be acquiring Audentes Therapeutics at a total cost of $3 billion.
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Medicinal cannabis product granted approval in Ireland
A medicinal CBD oil has been approved for importation, prescription and supply under the Medical Cannabis Access Programme (MCAP) in Ireland.
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Telstar promotes aseptic technology developments for pharma production
At CPhI (Frankfurt, November 5-7 2019), Telstar will be promoting the latest solutions in isolation technology systems, sterilisation and pharmaceutical freeze-drying applications, designed to ensure an aseptic and efficient production of pharmaceutical processes.
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Whitepaper: EU GMP Draft Annex 1: Potential impact on cleaning and disinfection
CLEANING AND microbial contamination control are critical focus areas in the pharmaceutical and medical device industries.
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Application note: Calculating maximum allowable carryover (MAC) for cleaning validation
This application brief presents a framework for how to establish acceptance criteria limits using TOC to comply with FDA best practice guidance for the life cycle approach to cleaning validation.
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Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
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OTC drug manufacturer receives warning letter for data integrity issues
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
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Whitepaper: Does QRM + RMM = Better EM
Facilities perform environmental monitoring (EM) to demonstrate a state of control.
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Data integrity for cleanroom monitoring
With a continual focus on data integrity and helping our customers meet regulations while generating actionable insights, Particle Measuring Systems provides a complete range of products and services.
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Concerns around Annex 1
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.
