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.