A focused introduction to the principles and practices of process validation within the (bio) pharmaceutical industry, by examining the 3-stage cyclical approach, including Process Design (PD), Process Qualification (PQ), and Continued Process Verification (CPV).
Aims and Objectives
This aim of this training is to provide participants with a foundational understanding of process validation in the biopharmaceutical industry, including its importance, regulatory requirements, and key concepts. Participants will learn about the purposes for undertaking thorough validation processes, as they relate to the manufacturing process of highly regulated medicinal products. The course will focus on key guidelines and standards at each stage of validation activities, using practical examples to illustrate concepts.
Course Content
Definition of product quality
The evolution of process validation approaches, in recent decades
The FDA-approved 3-Stage Process Validation lifecycle
Process Validation protocols and documentation
Critical quality attributes (CQAs) vs Critical Process Parameters (CPPs)
Sampling plans & Acceptance Criteria of Continued Process Verification
Concurrent Validation, Prospective Validation and Retrospective Validation.
Deviations and Change Management
Learning Outcomes
On completion of this programme the learner should be able to:
- Understand the importance of process validation in the (bio) pharmaceutical industry.
- Demonstrate an understanding of the regulatory requirements and guidelines related to process validation, including the three stages of process validation, and how to apply them.
- Identify the critical quality attributes (CQAs) and process parameters (CPP) of a biopharmaceutical product, and how this contributes to process validation
- Outline the meaning of “design space”, as it relates to biopharmaceuticals and ensuring the quality and safety of the final product
- Understand the concept of designing process validation protocols and related documentation.
- Describe the need for deviation and change management during the process validation cycle.
