The pharmaceutical industry has embraced the ISPE guideline, Commissioning and Qualification Baseline® Guide, as the standard for pharmaceutical engineers to follow as part of good engineering practices and as a strategy to meet current FDA expectations. CTI uses the Guide as a tool for enhancing communications between the many different stakeholders in startup of new facilities and processes. The Guide offers these diverse individuals a comprehensive value-added tool for consistent interpretation and cost-effective project execution
Compliance Team’s commissioning and validation specialists are experienced in executing commissioning and qualification activities for clients that are starting up new facilities and expanding existing production capacity as required to bring their products to market. Our teams are currently support facility, utility, and process equipment and control systems commissioning and qualification activities for a variety of pharmaceutical products (i.e., aseptic solutions, API, solid dosage forms, etc.) and technologies (i.e., CIP, SIP, WFI Systems).
CTI is also a preferred provider for government commissioning projects, having experience with defense projects providing both LEED Fundamental and Enhanced Commissioning of both renovation and design builds of barracks, hangars, headquarters, and training centers. CTI’s certified commissioning authorities have verified that commissioned systems achieve the owner’s project requirements (OPR) in compliance with the ACG Commissioning Guideline, ASHRAE Guideline 0-2005, and ASHRAE Guideline 1.1-2007 as needed to satisfy LEED requirements.
We are ready to share our commissioning and qualification experience and to facilitate understanding of the Guide’s cost-effective and practical approach. We will support your commissioning and qualification requirements and the on-time delivery of your critical projects to help meet your business objectives.