Aligning Non-Sterile Manufacturing with Annex 1: Developing a Robust Contamination Control Strategy (CCS)
The revised EU GMP Annex 1 guideline emphasizes contamination control more rigorously than ever, even for non-sterile manufacturing. While traditionally associated with sterile processes, Annex 1 principles provide essential insights for ensuring product quality and patient safety in non-sterile environments. With an increased emphasis on holistic Contamination Control Strategies (CCS), the guideline aims to ensure consistent product quality, patient safety and regulatory compliance.
Non-sterile manufacturing facilities face unique challenges in managing contamination risks, and failing to align with Annex 1 principles can lead to compliance gaps, product recalls or reputational damage. This webinar is designed to provide actionable insight into implementing Annex 1-aligned strategies in non-sterile manufacturing operations. Attendees will leave with a clearer understanding of how to bridge the gap between regulatory requirements, and practical, scalable solutions.
Contents:
Understanding Annex 1 Updates
- Overview of the revised Annex 1 guidelines and their implications for non-sterile manufacturing
- Key differences and similarities in contamination control for sterile and non-sterile environments
- Common misconceptions and pitfalls in Annex 1 alignments for non-sterile facilities
Developing a Contamination Control Strategy
- Components of an effective CCS tailored for non-sterile operations
- Integration of risk-based approaches and continuous monitoring programs
Risk Assessment and Mitigation
- Identifying contamination sources in raw materials, personnel, and equipment
- Practical strategies for managing cross-contamination during multiproduct manufacturing
Environmental Control and Monitoring
- Adapting environmental monitoring (EM) programs to non-sterile manufacturing requirements
- Setting appropriate limits and managing environmental deviations effectively
- HVAC systems, airflow patterns, and their role in contamination control
Cleaning and Cross-Contamination Prevention
- Cleaning validation strategies for shared equipment and non-sterile facilities
- Techniques to prevent cross-contamination during multiproduct manufacturing
Personnel and Hygiene Management
- The role of human factors in contamination risks for non-sterile products
- Establishing and enforcing hygiene standards, gowning procedures, and training programmes
Raw Material and Supply Chain Control
- Ensuring quality and consistency of raw materials to mitigate contamination risks
- Supplier qualification and monitoring for non-sterile product components
Facility and Equipment Design
- Aligning facility design with CCS principles to reduce contamination risks
- Equipment qualification and process optimisation for non-sterile manufacturing
Documentation and Continuous Improvement
- Creating and maintaining CCS documentation that aligns with Annex 1 requirements
- Leveraging deviation investigations and CAPA to enhance CCS effectiveness
Target Audience
- Quality Assurance (QA) and Quality Control (QC) professionals
- Manufacturing and operations managers in pharmaceutical production
- Regulatory affairs and compliance officers
- Environmental monitoring and microbiology specialists
- Facility design and validation experts
Duration: approx. 120 minutes
Recording from 04/2025
Language: English | Handout: English
Speaker: Martina Gjorgjevska
Note on contingent call-off: Please note that this webinar cannot be booked using an existing 10-webinar quota.
Group prices - your advantages at a glance
We offer attractive discounts and customised packages for your department or company from just 4 participants. With our flexible Streaming+ format including a live Q&A session, for example, you as a team are in direct dialogue with our expert to clarify your individual questions.
Feel free to contact us by email at info@alphatopics.de or by phone - we look forward to hearing from you.
- Martina Gjorgjevska
THE FORCE CT GmbH
E-Learning | Streaming im MP4 Format
Prizes & Conditions of Participation
per person plus VAT. - Payment upon receipt of invoice.
The fee includes for a single booking:
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