Commissioning & Qualification

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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 that 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
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Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.

1.877.787.0177

22320 Foothill Blvd. Suite 330, Hayward CA 94541