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Commissioning and Qualification Services
Since the release of the Commissioning and Qualification Baseline®
Guide in March 2001 by the International Society for Pharmaceutical
Engineering (ISPE), the pharmaceutical industry has been embracing the
guideline as a standard for pharmaceutical engineers to follow as part
of good engineering practices and as a strategy to meet current FDA
expectations.
Compliance Team’s validation engineers are experienced in executing
commissioning and qualification activities for clients
that are starting up new facilities and expansion of existing
production capacity as required to bring their products to market. Our
teams’ are currently supporting 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).
We use the Guide as a tool for enhancing communications between the
many different stakeholders in starting up new facilities and
processes. The Guide offers these diverse individuals a comprehensive
value-added tool for consistent interpretation and cost-effective
project execution.
We are ready to share our commissioning and qualification experience
and understanding of the Guides’ 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.
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