Developing a Pharmaceutical Contamination Control Strategy

The EU GMP Annex 1 revision has indicated that each company has a contamination control strategy. But what does such a strategy look like? What are the core elements? And how can risk assessment be used to address any identified gaps?

Our Developing a Pharmaceutical Contamination Control Strategy course, provides practical tools with a multidisciplinary approach for understanding types of contamination, contamination control measures, the application of risk tools to address concerns, in line with regulatory expectations.

A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event). 

The course is suitable for pharmaceutical professionals working within Quality Assurance, Operational Quality, Quality Control, Microbiology, Sterility Assurance, Production, Engineering and specifically, Qualified Persons, Quality Managers, QMS Specialists, Pharmaceutical Microbiologists, Quality Control Managers, Production Managers, Head of Quality and Compliance Managers etc.

A practical and risk based consideration of:

• Microbial contamination
• Sterility assurance
• Facility design
• Chemical contamination
• Particle contamination (visible and sub-visible)
• Viral control
• Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations.
• With guidance on how to identify, connect, risk assess, document and resolve the essential aspects.