Module 9. Secondary process validation: biotechnology processes

Aims

The aims/objectives of this module are to provide the student with an understanding of:

• the strategies adopted in the validation of biotechnology processes.
• the pre-requisites required before process validation may be undertaken.
• the relationship of the current process to that used to produce the clinical trial material.
• the Product Development Report.· the need to clearly define process boundaries.
• planning, execution and report preparation.

Learning outcomes

On completion of this module the student should be able to:

• understand the importance of relating the current manufacturing method to that used to produce the original clinical trial material.
• understand the importance of the Product Development Report.
• identify the pre-requisites required before process validation is undertaken.
• prepare a process Validation Plan and Protocol.
• identify critical process parameters and be familiar with the Proven Acceptable Range concept.

Tutor information

Trevor Deeks

See Module 8.