ABSTRACT
Process validation is clearly an essential component in developing and commercializing a new biopharmaceutical product. The activities required for process validation are complex and consist of contributions from many different departments within an organization. Achieving a consistent approach to process validation within
12.1 Introduction .................................................................................................. 355 12.2 Issues SpeciŒc to Process Validation at a CMO ........................................... 356
12.2.1 DeŒning Roles and Responsibilities ................................................. 356 12.2.2 Alignment of Approach and Process Validation Schedules ............. 356 12.2.3 Critical Quality Attributes and Risk Assessment Impact the
Validation Plan ................................................................................. 357 12.2.4 Communication Challenges .............................................................. 358 12.2.5 Equipment QualiŒcation ................................................................... 358 12.2.6 Stages of Process Validation ............................................................. 359 12.2.7 Data from Scale-Up ..........................................................................360 12.2.8 Scale and Number of Validation Batches .........................................360
