Commissioning & Qualification
Performance Validation’s core business is providing commissioning, qualification and validation services to the pharmaceutical, biotech, and medical device industries. Our teams have experience providing a turn-key solution to your project needs, or can provide resources to supplement your existing team1. We have supported projects ranging from 1-2 week system qualifications to multi-million dollar greenfield manufacturing facilities – and everything in between.
Our approach to project delivery and execution is to utilize a balance of Customer requirements, Regulatory requirements, and Industry Best Practices. This produces a Right-Sized, compliant solution that meets customer needs. We strive tirelessly to provide our clients peace of mind that their commissioning and qualification expectations will be met and exceeded.
Services offered:
Performance Validation offers the following services related to Commissioning, Qualification, and Validation:
Note 1: Within the State of North Carolina, Commissioning is defined as Engineering work per BP-0501-1Rev.1 dated 12/09/04. As such, Performance Validation (PV) will only perform commissioning activities within North Carolina as a) staff augmentation to a company licensed to perform engineering within the state of North Carolina, or b) as staff augmentation to the pharmaceutical manufacturer.
- Master Plan (verification, commissioning, validation, project plan) development & implementation
- Risk Management
- Per the ISPE Baseline Guide for system and component classification
- Per ICH Q9 for use of standard quality tools to facilitate risk based on scientific knowledge and protection of the patient
- Per GAMP5 for the application of risk to automated or quality systems
- Development, training and implementation of Good Engineering Practices to support the commissioning effort
- Requirements & Specifications development
- Design/enhanced design review
- Vendor Management including audit, assessment, and testing
- Change management/ configuration management prior to system turnover and acceptance
- Testing (Commissioning and Qualification, Verification, Validation, or other testing activities (FAT/SAT))
- Formal release/turnover activities and System Acceptance
- Periodic Review (e.g., annual audit) of the qualified systems
- Autoclaves
- Barrier Isolators w/sterility testing (VHP,ETO)
- Depyrogenation Ovens
- Fermenters
- Filling Equipment and Lines
- Fluid Bed Dryers
- Glassware Washers
- Lyophilizers
- Mills and Granulators
- Packaging Equipment and Lines
- Pasteurizers
- Tablet Presses
- Transfer Systems
- Administrative
- Animal Health
- Aseptic
- Bulk API
- Cell Culture
- Clinical
- DEA Vaults
- In Vitro Diagnostic
- Pilot Plant
- Quality Control Laboratories
- R&D Laboratories
- Solid Dose (Dry Products)
- Temperature controlled warehouses and production areas
- Walk in Freezers/ Cold Rooms
- Clean out of Place/ Clean in Place Systems
- Clean Steam
- Critical Air and Gases
- HVAC systems
- Non-Critical Utilities
- Water For Injection Systems
Need help? Contact Performance Validation to discuss how we may help you on your next project or to request additional information on our CQV service offerings and experience.