Facility Commissioning and Qualification
The design, construction, commissioning, and validation of pharmaceutical facilities are significant challenges for project managers, engineering, and quality professionals. Whether it is a new or upgraded facility, commissioning and facility validation is the foundation for assuring success in further manufacturing process validation. Before you begin validating a manufacturing process, an acceptable facility, and the utilities and equipment to support manufacturing operations must be in place. Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently produce the desired results according to predetermined specifications and quality attributes) activities will establish and provide documentary evidence that the premises, supporting utilities, equipment, and processes have been designed, installed, operates in accordance with the requirements of cGMP.
Involvement of different functional users, with varying skill-sets and expertise, with reliance on unproductive paper based validation leads to delayed review, approval, inconsistency in documentation, discontinued information in different phases of validation, lack of real-time control over individual tasks result in unreasonably high commission and qualification costs and delays. Overall, there is no control on the process.
The cost of validating a facility is determined by time spent on documentation, development of protocols and Standard Operating Procedures (SOPs), and the time spent on actual fieldwork, data collection, and analysis. These costs have increased over the years, reflecting higher standards required by regulatory authorities, and also because industry has adopted inefficient and costly blanket validation compliance strategies. As a result of this, there is a continuing struggle and challenge of meeting regulatory requirements, keeping overhead costs down, and running a profitable business. It is interesting to note that a good rule of thumb is that total validation costs may run from 4-8% of the total project cost for typical pharmaceutical plant expansion projects.
Typical commissioning and qualification process detailed in the following diagram,
ValGenesis is a web based validation lifecycle management system configured to manage facility commissioning and qualification projects. Unlike manual paper system, ValGenesis allows engineering and validation professionals to control and track the status of each equipment or system from the initial requirements through risk assessment, traceability matrices generation and qualification. In addition, ValGenesis software system for Life Sciences automates the generation of the numerous commissioning and qualification test protocols and manages their execution through completion, including resolution of deviations. Qualification protocols are generated and may be taken offline for execution in the field (for example on tablet PCs or laptops), and synchronize back into the system where the work process continues. ValGenesis comes with out-of-the-box, easily customizable workflows which support handover, qualification, and change activities.
- Documenting commission and qualification documents in compliance with FDA regulatory requirements
- Managing design and validation data with documents over the plant life cycle
- Risk Assessment at the system and functional levels
- Asset Management
- Periodic Review and construction schedules
- Quality gate checks with construction schedules and associated qualification documents
- ValGenesis Provides validated connectors for cornerstone systems including SAP, MS SharePoint, HP QC/QTP and EMC Documentum.
- Configurable electronic workflows supported by automatic audit trails and electronic signatures reduce the time needed to complete the project and ensure that FDA requirements are met. Integrated change control and configuration management also ensure that documents are kept compliant
ValGenesis software system offers benefits for commission and qualification and complete plant life cycle management, and is configured for pharmaceutical industry needs such as:
- Reduce time to market for fast-track projects plus modular and stick-built designs
- Reduce commissioning and validation effort through work process automation
- Maximize patent window and minimize time to market by enabling global engineering via 24-hour access to a single source of all up-to-date engineering information
- Expedite the re-configuration of a plant for the production of different drugs through electronically managed plant configuration management
- Track and manage disposition all deviations, using best practice electronic work processes
- Greatly eases a plant manager’s ability to respond to spot inspections and audits, allowing them to view all the information available about a tag, item of plant, system, or almost anything else, including the entire plant, at the revision level current at a given point in time.
- Users are able to connect and synchronize the equipment inventory with requirements, risk assessments or qualification documents. This ensures that the inventory is kept up-to-date and that the status of each item of equipment can be promptly justified by retrieving the attached documents
- Monitors compliance throughout the project (including project specific procedures)
- Documentation and change control activities easily managed with engineers and contractors
- Provides unique content level linking between documents to reveal change impact
- System GxP impact assessment and qualification status included into Validation Master Plan (VMP)