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As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever

pharmaphorum

With attention and resources focused elsewhere during the pandemic, it’s likely that many facilities may have slipped into a state of non-compliance, which may result in unsuccessful inspections. Doing so means that businesses can check their compliance before an FDA inspection. However, we understand that this is not always possible.

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11th Annual Pharmaceutical Microbiology Europe Conference

pharmaphorum

Harnessing Alternative Rapid Microbial Methods for a Successful Contamination Control Strategy. Key Highlights for 2023 Conference: Optimise your contamination control strategy and review the initial impact of Annex 1. Learn how to utilise the latest microbiological methods to modernise your contamination control strategy.

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GxP Best Practices for Safer, Smarter, Faster Clinical Research

Advarra

GxP in Clinical Trials To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market. GDP is Key to Maintaining Compliance Want to instill confidence in your GxP?

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Can J&J’s vaccine approval erase bad pharma?

World of DTC Marketing

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties.

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2nd Annual Aseptic Processing Conference

pharmaphorum

Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0

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FDA Proposes Substantial Changes to Agricultural Water Requirements

FDA Law Blog

In 2017, in an effort to lighten the burden for affected parties, FDA proposed to extend compliance dates until at least Jan. Despite opposition, FDA finalized the proposal to extend the compliance dates in March 2019. susceptibility of the produce to surface adhesion or internalization of contaminants); Environmental conditions (e.g.,

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Five ways to ensure pharma water is GMP compliant

The Pharma Data

Avoid risking the quality of water in manufacturing practice, subsequent product process delays and compliance issues with this handy guidebook. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Add bookmark.