In year 2011, FDA published its new guidance for industry on Process Validation: General Principles and Practices. Even though the new guidance aligns process-validation activities with the product life-cycle concept and with existing harmonized guidelines such as the ICH Q8, ICH Q9 and ICH Q10. For majority of the regulated life science companies, the guidance created a systemic shift in the expectations of their validation programs.
Moving from current 3 batch process to 3 stage process requires significant changes with traditional validation process and approach. An additional challenge is that traditional process validation is a paper-based very inefficient and time consuming process. Paper-based process validation lifecycle creates a significant amount of challenges while managing the process validation lifecycle as per new process validation guidance. The new process validation guidance recommends, the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. It is nearly impossible to adopt and manage the new process validation process without the use of adequate software systems and tools.
The following challenges are found with manual process validation:
- Difficult to find critical process and product lifecycle data related to design and development
- Process design/development stage is not integrated with validation stage
- Product lifecycle data found in disparate systems
- Inefficient and inadequate knowledge management from Design to Qualification and to Continuous process verification.
- Paper based Process Performance Qualification (PPQ) creates data integrity issues, delays and errors
- Lack of visibility to product lifecycle data across the organization
EFFICIENT MANAGEMENT OF 3 STAGE PROCESS VALIDATION LIFECYCLE THROUGH VALGENESIS VLMS
Managing the process validation lifecycle in ValGenesis enables the ability to integrate the 3 stages of the lifecycle including process Design/Development, Qualification and Continuous Process Verification. Managing the process validation lifecycle in ValGenesis provides the ability to have a central repository for all data and documentation related to product design, development and validation. This provides a significant amount of advantages because all the lifecycle data resides in one location instead of binders and paper documents that are not integrated in one single repository.
The integration between the 3 stages of the process validation lifecycle enables efficient issue resolution and investigations when there is an event of process failures during validation and commercial operations.
Managing the process validation lifecycle electronically in ValGenesis provide a significant amount of benefits and efficiencies. The following benefits can be achieved when managing the process validation lifecycle in ValGenesis VLMS:
- Continuous Process Verification stage is integrated with Design and Qualification stages
- Paperless lifecycle management enables efficiency and cost reduction
- Data integration throughout the entire process validation lifecycle
- Global visibility to data and process validation status of product across the manufacturing network
- Integrated knowledge management across the Lifecycle stages
- Statistical analysis at any stage of the process validation lifecycle stages
- Paperless execution eliminates challenges created with paper based validation
Managing process validation lifecycle through ValGenesis VLMS enables Risk management as lifecycle at the parameter and attributes level (CPP, CQA, etc.), connects all the PV stages with seamless data integration, efficient knowledge management, provides access to statistical analysis at any stage, define the specification and alert limits for process parameters and attributes, alert the users if there is any Out of Specification limits (OOS), eliminates the data integrity issues, enables electronic execution of PPQ and provides interfaces with other process control systems to enable continuous process verification.