Practical Steps to Compliance with EU GMP Annex 1

How to Design & Deliver a Fit-for-Purpose Contamination Control Strategy and Appropriate Quality Risk Management & Cleanroom Technology

Topic: Practical Steps to Compliance with EU GMP Annex 1

About this Ebook

In August, the revised EU GMP Annex 1 requirements, related to the Manufacture of Sterile Medicinal Products, were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled within a year.

Detailing the 3 key steps that you must take and breaking them down to provide you with advice and more awareness of how to tackle this, our guide ensures that you carry out the procedures correctly and in the right order. We provide time frames and practical steps that put you ahead of the game. Plus, discover what your facility must be doing to meet these requirements.

Documenting all of this is crucial: without a formal record, manufacturers will be unable to demonstrate their rigour.

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