PHARMACEUTICAL & RESEARCH SECTOR
CML have successfully undertaken all commissioning, management, consulting, validation, and record documentation services on a wide variety of complex pharmaceutical / healthcare production and research facilities.The critical nature of the engineering and control systems on such facilities, and the proving processes that are therefore a prerequisite, lead to a clearly defined need for a structured commissioning and validation plan.On such appointments our role is concentrated on the specific challenges associated with this sector including :-
 
  • Commissioning to GMP validation – Where FDA GMP validation procedures are to be undertaken we ensure the entire commissioning process of the systems to be validated are undertaken and certified in a structured format to mirror the requirements of Design Qualification, Installation Qualification and Operational Qualification. These processes are agreed prior to commissioning start with the validating authority, thus ideally reducing the overall validation duration and cost.
  • Stability trials & proving – Where stability trials are required for validation purposes – for example to satisfy Home Office requirements – we undertake the complete management and testing procedures to achieve certification and licensing; working directly with the validating authority from design through to completion to ensure all requirements are met. This includes production of the required stability trial protocol documentation – a complete commissioning and validation plan – full testing and final demonstration.
  • Services & building fabric interface – Important in any facility but essential in this sector where pressure regimes are critical to systems performance. Our commissioning plan focuses on ensuring the building fabric completion milestones are clearly defined and monitored to allow commissioning and validation to progress unhindered.
CASE
STUDIES
Wellcome Trust Genome Campus
 
 
 

NEWS

December 2011
Rolls Building Officially Opened by HM The Queen

June 2011
A New Name for UKCMRI - The Francis Crick Institute

September
2010 CML Sustain Appointed on Birmingham New Street Redevelopment

OUR PROJECTS
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