Skip to content
PQqpdE8vc (3)


Reduce cleanroom compliance risks and stay ahead of EU GMP Annex 1 and global audits.

What you will learn:

  • What Annex 1 and the shift from checklists to performance mean for your site.

  • Key sources of contamination risk, from HVAC to people.

  • How to turn Contamination Control Strategy, environmental monitoring and gowning into integrated daily systems.

  • How stronger investigations, CAPA and leadership behaviours builds lasting cleanroom compliance culture. 

Is this e-guide for you?
This guide is for pharma leaders in sterile manufacturing, such as:

  • Quality and QA managers

  • Production and operations heads

  • EHS and engineering leaders responsible for cleanrooms

  • Site leadership teams preparing for EU or US inspections

Written with industry experts:
This e-guide is based on an expert roundtable held in July 2025 with:

  • Shyam Khante, senior GMP advisor and Founder, Shyam Khante and Associates

  • Manish Bhatkar, Founder and CEO of RedLotus Pharmtech

  • Manas Kumar, Global Director of Pharma at Lindström Group

    They share real inspection experiences, common pitfalls and practical solutions for sterile facilities.