Industry insight: 2018 Drug GMP warning letters

GMP consultant Barbara Unger comments on the trend seen in warning letters issued by the FDA, specifying OTC nonprescription drugs and data governance as problem areas

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Johnson & Johnsonís asbestos woes continue

The US Justice Department will be investigating claims that the healthcare giant sold asbestos contaminated talc

EMA completes pre-approval inspection at WuXi Biologics

The European Medicines Agency has examined cGMP facilities for the production of Trogarzo

British biopharma consultancy firm opens in Dublin

Boyds makes a strategic move to Ireland to ensure continuity of service to clients after Brexit

Poland and Slovenia join EU-US mutual recognition agreement for inspections

GMP drug plant inspections conducted by health authorities in Poland and Slovenia will now be accepted by the US FDA

UK signs healthcare-focused Memorandum with Russia

The Medicines and Healthcare products Regulatory Agency has signed a Memorandum of Understanding with its Russian ...

FDA clarifies what went wrong in the valsartan fiasco

The US agency has said a problem with the manufacturing process is the likely source of contaminants

Cleanroom suitability: Making it right for the process

Joachim Ludwig, Colandis CEO, explains what it takes to determine the compatibility of machinery, supplies and tools ...

Gene and cell therapy gets FDA attention

The FDA announces plans for future cell and gene therapies, even as the US government shutdown continues

FDA is counting the pennies

Following the US government shutdown, the Food and Drug Administration struggles to keep up with work with rapidly ...

Cleanroom Technology Conference opens registration to attendees for 2019

Held on 21-22 May at the Birmingham NCC, the conference will put delegates ahead of the curve

Air filtration to the test

Camfilís Alan Sweeney looks at the benefits that the new global standard ISO 16890 brings to clean processing ...

EU GMP Annex 1: What's new for cleaning and disinfection

The revised Annex 1 of the GMP guidelines is close to publication. Here, James Tucker, Ecolab Life Sciences, explores ...

BSI to certify organisations to the revised food safety standard ISO 22000

The business standards company has gained accreditation from ANAB

New Upperton facilitites in Nottingham pass MHRA inspections

Spray drying specialist has invested in building enhancements and in the expansion of its processing and analytical ...