Happy New Year (2026)

By Colin Young on January 6, 2026

New year, same mission — just a little less stress? 🥂

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FDA PAI Prep: The Aseptic Olympics Are Coming

By Colin Young on December 9, 2025

You know that feeling when you’ve just completed a massive project, validation is complete, and you’re ready to ship product? That sweet relief is immediately followed by the cold dread of realizing the FDA Pre-Approval Inspection (PAI) is looming…

In aseptic manufacturing, the PAI isn’t just an inspection -it’s the regulatory World Series, the Aseptic Olympics- success demands a flawless routine without dropping any SOPs. The medal is market access; the judge is the FDA.

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De-Risking Aseptic Cleanroom Design: The New Mandate Post-EU GMP Annex 1 (2022)

By Colin Young on December 4, 2025

The transition to the revised EU GMP Annex 1 (2022) demands a shift from simply building a clean space to engineering a comprehensive Contamination Control Strategy (CCS). Validation issues are often rooted in the design phase, where planning assumptions misalign with operational reality.

If your facility design does not thoroughly address risks associated with operator interventions or material and equipment transfer to sterile areas, you are potentially compromising your sterility assurance.

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Welcome to the Gpharma Solutions blog

By GPharma Webmaster on December 1, 2025

Welcome to the GPharma Solutions blog!

Here we will be posting current goings-on with the company in addition to informative posts regarding subjects relevant to the services we provide. You may easily find posts based on the category of post and/or tags indicating its subject!

This blog also supports RSS. If you wish to take advantage of this, use the following link: https://gpharmasolutions.com/blog/index.xml

More to come soon. Stay tuned!

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