Effective Process Validation Strategies for Successful Product Commercialization
Complimentary
Learning Level: Intermediate
Time: 1100 - 1200 EST
Session Length: 1 hour
This presentation delivers a comprehensive and detailed exploration of essential elements critical for successful process validation within the pharmaceutical industry through real-life case examples. The webinar will elucidate the lifecycle approach to process validation, emphasizing the integration of product and process development, validation of commercial manufacturing processes, and maintenance of process control during routine commercial production.
Participants will gain a deep understanding of the importance of detecting and comprehending sources of variation, the status of equipment and materials used, and the seamless linkage between development and technology transfer stages. The webinar will delve into the risk assessment phase of process validation, focusing on determining the number of process validation (PV) batches required. This assessment will be based on residual risk analysis derived from product knowledge, process understanding, and control strategy effectiveness, utilizing experience and statistical methods for justification.
The session will also cover the justification of Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) for an effective control strategy, employing tools such as SIPOC (Suppliers, Inputs, Process, Outputs, and Customers) diagrams and Failure Mode and Effects Analysis (FMEA). Additionally, the development of robust sampling plans and associated acceptance criteria will be addressed, with a detailed discussion on three common sampling strategies. The application of statistical tools for the evaluation of process validation results will be thoroughly examined to ensure the achievement of process validation objectives through real-life cases examples from CDMO environment.
Learning Objectives
- General aspects for a successful Process Validation
- Process validation incorporates a lifecycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production
- A successful validation program depends upon information and knowledge from product and process development/ Donor site
- Manufacturers should detect the presence and degree of variation, understand the sources of variation
- Status of equipment & Materials used
- Link with Development/ Technology of transfer stages
- Assessing risks in Process Validation stage
- Number of PV batches determination: assessing residual risk based on product knowledge, process understanding, and control strategy effectiveness. Turning this risk knowledge into the justification for the number of validation batches to manufacture can be based on experience, statistics, or a combination.
- Justification of Critical Process Parameters and Critical Material Attributes for an effective control strategy using SIPOC and FMEA tools.
- Sampling plans and statistical evaluation of PV results
- The development of suitable sampling plans and associated acceptance criteria, if applicable, are essential to achieving the objectives of Process Validation
- Discussion on three common sampling strategies: Simple Random Sampling, Stratified Random Sampling, and Systematic Sampling
- Statistical tools for the evaluation of process validation results
