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How to Audit - Bulk Biotech Operations

Location: Manchester Marriott Victoria and Albert Hotel, Manchester, UK

This course is designed to give existing auditors, who have no ‘bio’ background, sufficient exposure to some of the specific issues involved in biologics and biotech processing to allow them to approach a biologics/biotech audit with confidence. GMP requirements of both EMA and FDA (CBER) are addressed. The course is ideal for delegates who have either previously attended NSF-DBA’s IRCA certified Pharmaceutical Quality Management Systems Auditor/Lead Auditor course, or who already have a good understanding of the basic principles and practices of auditing and wish to expand their technical understanding to biologics/biotech GMPs. The course can also contribute to registered auditors’ and lead auditors’ professional requirement for continuing professional development (CPD).

This course will also be ideal for manufacturing and quality personnel already working in a biologics/biotech facility who wish to undertake effective self-inspection.

What You Will Learn

How to develop an audit aide-mémoire for risk-based auditing of bulk bio manufacturing
A structured approach to an audit that will address both EMA and FDA expectations
Reasonable expectations for environmental and in-process monitoring for bio facilities
Risk-based prioritisation of activities to be audited when time presses (doesn’t it always!)
Practice, in a non-threatening situation, in classification of bio facility audit observations

Course Outline

Developing an aide-mémoire for audit of a facility manufacturing bulk biologic and biotech APIs - Risk-based planning of the audit
Interpreting and auditing against current EudraLex Volume 4 Annex 2 and FDA’s Compliance Program Guidance Manual (CBER 7345.848) requirements
Key quality systems for biologics and biotech bulk manufacture, including:
Biological raw materials sourcing and control
Technology transfer and process validation for biological and biotech API processes
Cleaning validation for biological and biotech API processes
Critical review of deviation management in a biologics/biotech context
Interpreting and auditing against regulatory requirements and industry best practice in respect of:
Facility, utility and environmental monitoring and control
In-process monitoring and control
Assessing performance in respect of:
Bioburden management and control
Cross-contamination avoidance
Control of ‘live biologics’ operations
Appreciating the limitations of bioassays in control of bulk biologics manufacture
Review of biologics and biotech process documentation
Classifying biologics and biotech audit observations

Why not bring your problems for discussion?

The course offers an ideal opportunity to speak to an experienced tutor and to delegates who are in similar roles. Our courses are planned to inform you and also to enable you to gain answers to your specific queries via debate, group work sessions and a panel discussion.

For further information about this course or to register please visit

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