Validation and Commissioning
Our validation specialists are trained in current Good Manufacturing Practices (cGMP) and have experience implementing them in the Pharmaceutical, Biotech, Food and Beverage, Consumer Products and Chemical Industries. Integrating commissioning and validation with design engineering and scheduling allows our validation specialists to have input from conceptual design through turnover, resulting in the design and construction of a validatable facility or system.
Process Plus works directly with our clients’ engineering, operations, and quality personnel to provide commissioning and qualification (C&Q) documentation that meets their needs for compliance with federal regulations.
Our validation specialists provide turnkey commissioning and qualification services including C&Q project management and coordination as well as document development and execution from the commissioning & validation master planning phase through validation summary reports. We have successfully commissioned and qualified GxP facility flows & finishes, manufacturing and packaging equipment, utility systems, and HVAC systems / environmental conditions servicing production suites, packaging suites and warehouses.
Specifics
- cGMP Compliance Audits
- Gap Analysis
- Risk & Impact Assessment
- Validation Master Plans (VMP)
- Design Qualifications (DQ)
- GAMP Specifications (URS/FS/DS)
- Qualification Protocols (IQ/OQ/PQ/CV)
- Commissioning Plans (CP)
- TOP Requirements
- Factory & Site Acceptance Tests
- cGMP Construction Segregation Plans (CSP)
