Our industry experts provide practical advice and solutions tailored specifically to your organizational requirements, internal resources and capabilities. We understand the complexities of becoming a trusted partner and have developed proven C&Q models which intelligently apply risk-based tools to reduce typical C&Q program time and cost without adding compliance risk. These proven approaches are based upon decades of experience working effectively with General Contractors, Operations, Facilities, Engineering, and Quality functions. Pharmatech’s approach to C&Q is based upon User and Functional Requirement Specifications, Vendor Documentation, Basis of Design (BOD) and Supplier provided documentation to develop your commissioning and qualification documents. This approach, coupled with risk-based analyses, leverages commissioning activities to reduce project execution time and required Installation and Operational Qualification testing moving into Performance Qualification testing as quickly as possible. Pharmatech has designed and implemented C&Q systems which embrace the principles outlined ASTM 2500E-07 as well as the classical C&Q model defined by the 1987 FDA guidance. Services include but are not limited to the following:
  • Commissioning and Validation Master Plans
  • Basis of Design
  • User Requirement Specifications
  • Functional Requirements Specifications
  • Design Qualification
  • Construction Qualification
  • Turn-Over-Package Preparation
  • Equipment/Utility/System Commissioning
  • Equipment and Utility FAT and SAT
  • Equipment and Utility Qualification (IQ, OQ and PQ)
  • Facility Qualification

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.