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Nitrosamines : no one-size-fits-all method. A testing strategy tailored to your product.

📃 Since 2019, the regulatory framework on nitrosamines in pharmaceutical products has kept evolving. Systematic risk evaluation, confirmatory testing, marketing authorization variations, lifecycle management : the ICH M7 guidelines have progressively expanded these requirements for manufacturers. But beyond the regulatory text, the real challenge is analytical : detecting genotoxic impurities down to 18 ng/day (CPCA […]

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ICH Q3E : How the new guideline reshapes your Extractables & Leachables (E&L) studies

📃 ICH Q3E is set to reshape how Extractables & Leachables (E&L) studies are designed and controlled. Released as a draft in August 2025,...
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CEBIPHAR updates

Nitrosamines : no one-size-fits-all method. A testing strategy tailored to your product.

📃 Since 2019, the regulatory framework on nitrosamines in pharmaceutical products has kept evolving. Systematic risk evaluation, confirmatory testing, marketing authorization variations, lifecycle management...
Read more
CEBIPHAR updates

Injectable Hyaluronic Acid : Overcome Your Analytical and Regulatory Challenges

📃 Hyaluronic acid has established itself as a key segment of the injectable medical device market, in both aesthetic medicine and orthopaedics. Driven by...
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CEBIPHAR updates

Sterile Products : Secure Your Compliance with GMP Annex 1

📃 The revised Annex 1 of the EU Good Manufacturing Practices, applicable since 2024, represents a major milestone for sterile products. Beyond reinforced regulatory...
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CEBIPHAR updates applied microbiology Cebiphar

Particle Contamination Challenges – USP 788 : Are you ready for the chapter becoming official on August 1, 2026 ?

📃 The USP <788> chapter “Particulate Matter in Injections” is evolving and will become officially applicable on August 1, 2026. Following updates published in...
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CEBIPHAR updates Technical-regulatory advisory service

USP 382 – Packaging QC : A new chapter applicable from December 1st 2025

📃 Since December 2025, USP <382> introduces a more comprehensive approach to evaluating packaging systems. This marks a significant shift : analysis is no...
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