Industry insight: Process validation and monitoring

GMP consultant Barbara Unger comments on the trend seen in warning letters issued by the FDA to drug product manufacturers citing process validation and monitoring programmes in 2017

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Cherwell releases guide to EM processes and validation

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

Sanofi halts manufacturing following pollution claims

A conservation group has accused a Sanofi plant in France of releasing hazardous materials far above authorised ...

The future relationship between the UK and the EU

More clarity is now available regarding regulatory cooperation on medicines between the UK and the EU following the ...

Global standardisation fortifies modern cleanroom industry

Without modern cleanroom technology many products and process such as the semiconductor industry, nanotechnology or ...

Multi-state outbreak of salmonella linked to Kelloggs

The FDA is advising consumers to avoid eating and discard any Kellogg's Honey Smacks cereal, regardless of size or sell ...

Fipronil found in eggs from the Netherlands

Insecticide contamination scandal as Germany recalls 73,000 organic eggs

How can new GMP regulations inspire and improve biosafety?

Henriette Schubert, global expert in process architecture, laboratories, biocontainment and GMP facility design at NNE, ...

Expansion of global oncology testing for clinical trials

Pharmaceutical Product Development and NeoGenomics have formed a strategic alliance to provide global pathology and ...

Micronclean updates ISO certifications

Micronclean has transitioned to ISO13485:2016 and ISO14001:2015 following recent surveillance audits

Industry insight: Data integrity deficiencies

Warning letters issued by the FDA in 2017 that cite failures in data integrity herald a trend for 2018. Barbara Unger, ...

VHP as sterilant for use in isolators?

Andrew Hopkins, senior GMP inspector, MHRA, explains the guidance around the use of vaporised hydrogen peroxide for ...

Adequately establishing contamination risk in drug products

Recent changes within the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) put emphasis on risk ...

Food contamination fears if Brexit deal not agreed

The Local Government Association has warned a failure to protect access to key intelligence post Brexit, will weaken ...

Implications for packaging in new API Guidance

Recently the US Food and Drug Administration released a guide to clarify good manufacturing practice for API production ...