Project Summaries

Commissioning & Qualification - Device Assembly
Commissioning & Qualification - Product Manufacturing

Commissioning & Qualification

Performance Validation’s core business is providing commissioning and qualification 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.

 

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.

Services Offered

• 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 the 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

System Experience - examples

Equipment & Equipment Automation

• 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

Facilities

• 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

Utilities

• Clean out of Place/ Clean in Place Systems
• Clean Steam
• Critical Air and Gases
• HVAC systems
• Non-Critical Utilities
• Water For Injection Systems