The Parenteral Drug Association (PDA) is a leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community.
SeerPharma Senior GMP Consultant Michelle Peake has been invited to speak at PDA Annex 1 Implementation: Inspection Ready Workshop 2025, 17 - 18 June 2025 in Bangkok, Thailand.Whether you're preparing for your first inspection or strengthening your Contamination Control Strategy (CCS), this is your moment to act with clarity and confidence. The 2-day event blends conference and workshop elements to give you practical tools to prepare for inspections and build lasting GMP readiness.
Michelle will be speaking on day 1 addressing the topic of Cleanroom Design and Environmental Monitoring: Meeting Annex 1 Standards
The revised Annex 1 in PIC/S Guide to GMP PE 009-17 focuses on building Quality Risk Management (QRM) into all activities, leading to a holistic Contamination Control Strategy which includes your Environmental Monitoring (EM). Your facility design (new or existing) plays a direct and foundational role in shaping how you perform EM, but now the EM program needs to be justified with a documented comprehensive risk assessment. What is required? What must we do to comply? It is easy to identify a risk qualitatively (is it a risk or not?) but how much of a risk is it and where do I have to monitor? In this session we’ll explore how effective cleanroom design and environmental monitoring programs are foundational to the contamination control strategy
Learn more about this event, including key presenters, detailed agenda and registration on the event website.
Contact us if you'll be attending and would like to connect.
You may also be interested in a recent webinar Michelle delivered on Contamination Control Strategy (CCS): How to Prepare Your Documentation.
The revised GMP Annex 1 doesn’t just require isolated controls—it calls for a comprehensive documented Contamination Control Strategy (CCS). This will be a big undertaking for some companies, as it is not just a matter of referencing existing SOPs, but assessing the relationship between each of the 16 parameters.
What does that mean in practice?
For instance, how could material transfer into the cleanroom have an impact on the cleanroom environment? Are you transferring on a trolley through a dedicated airlock? Is that trolley (and the trolley wheels) transitioning from a lower (dirtier grade) into a higher (cleaner grade)? What contamination could you be bringing into the cleanroom? Can we mitigate that risk or do we need to put in a control measure?
