FDA strengthens sterile injectable drug inspections

Scott Gottlieb, commissioner of the US Food and Drug Administration, said new protocol of inspection has been designed to modernise the agency’s oversight and reporting of inspections at manufacturing sites

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SGS establishes South Asia Centre of Excellence for elemental analysis

Laboratory in Chennai now operates three ICP-MS systems for compliance with updated ICH Q3D regulatory guidelines on ...

Catalent to open second clinical supply facility in China

Facility in Shanghai will have three controlled temperature rooms operating and will also offer returns and destruction ...

Cross-contamination risks found at Recipharm UK site

The Swedish CDMO has received a non-GMP compliance warning following inspection at its site in Lancashire

Tablet PCs in cleanrooms: Pros and cons

A look at the decisive factors to consider when implementing mobile PCs in a cleanroom-rated production environment

Cell and Gene Therapy Catapult centre gets green light

The independent cell and gene therapy researcher and industry partner, working with Innovate UK, has been granted new ...

Protak Scientific's enzymatic indicator gains MHRA support

The UK's Medicines and Healthcare products Regulatory Agency has agreed to form a focus group to discuss the use of ...

Expert guide: Single-use supply chain risk management

Industry experts at Avantor describe a supply chain strategy to help drug manufacturers with multiple locations around ...

Brexit could force UK to relinquish control of pharma regulations

According to GlobalData, recently released Government technical papers indicate UK will be forced to relinquish control ...

Report finds innovation is being hindered by regulators

CPhI Worldwide releases its sixth Annual Report ahead of the global pharma event taking place in Madrid, 9-11 October

A lifecycle approach to the qualification of analytical procedures

Dr Christopher Burgess, ECA Analytical Quality Control Group, looks at the changing face of validation and explains the ...

Cleanroom validation: Quality of the product to the front

Cleanroom validation is a multifaceted project, so it is advantageous to have a dedicated project manager to lead, ...

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 ...

Tracking technology takes centre stage at Cleanzone 2018

The cleanroom trade show on 23–24 October in Frankfurt will showcase the latest trends on access control, monitoring ...

Cherwell releases guide to EM processes and validation

New eBook discusses environmental monitoring and the revised draft of EU GMP Annex 1