Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

Microorganisms can be found in any aspect of pharmaceutical and, especially, biopharmaceutical manufacturing. Understanding where to look for microorganism and how these are introduced into your process will provide success when being reviewed by an auditor. It is not enough to identify microorganism in your process, but to understand, how, where, when, and why the microbes are in your process. These are questions regulatory auditors will ask when your facility is being inspected. 

The session provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. 

This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.

The microbial aspect of pharmaceutical/biopharmaceutical manufacturing is a key component of the overall manufacturing process. Understanding this component is vital in ensuring a pharmaceutical product meets the expectations of a regulatory agency. If this component of the manufacturing process is not well understood, consequences to be harmful to the patient and subsequently the company producing the product.

Topics covered include:

• International regulations (ISO)
• Federal regulation (FDA, USP)
• Room classifications and how applied to manufacturing
• Auditing company environmental programs for effectiveness
• Reviewing of documents in relation to microbial aspects
• Sources of common microorganisms
• Identify root causes for many microbiological excursions

This webinar has been designed for the following personnel in pharmaceutical manufacturing, contract manufacturing and biopharmaceutical organizations where microbiological aspects are monitored and reported. 

• Quality Assurance Personnel
• Quality Control Personnel
• Microbiology Professionals
• Validation
• Manufacturing
• Quality System Auditors
• Warehouse Managers
• Facilities/Maintenance
• Regulatory and Compliance Management