Commissioning and Qualification

Validation of a manufacturing process requires a suitably qualified operating environment. This means good operational procedures, methods, instructions, trained personnel and a good qualification of the equipment, facilities and services involved in the process.

Qualification, carried out according to a methodology of risk management (ICH Q9) in order to focus on the critical aspects of each qualified element and, at the same time, to optimize time and resources, constitutes a key factor to provide the necessary evidence of knowledge and control of the equipment and of the process environment

Likewise, qualification must be considered throughout the entire lifecycle, from the initial design stages to the release of the facility, utilities or process equipment. The following diagram shows the main stages of the typical facility and equipment lifecycle and the required qualification activities:

TDV’s methodology for commissioning and qualification is based on coordinated work with equipment and service suppliers, the engineering in charge and the engineering department of the property.

In this way, we provide the client with the necessary experience and knowledge to meet the GMP compliance objectives in the design, commissioning and qualification stages, integrate quality in the project with validation activities, standardize quality standards and qualification documentation and optimize the resources of the Engineering departments with the participation of TDV.

 

TDV’s experience in the qualification and commissioning of facilities and equipment is backed by years of successful inspections and audits:

  • Design Review: conceptual design & detail
  • Preparation of Validation Master Plans (VMP)
  • User Requirements
  • Risk Analysis of Facilities and Equipment
  • Management of suppliers
  • Preparation and execution of qualification documentation

 

For more information on Qualification and Commissioning, please contact:

Anna Cluet
acluet@tdvct.com

Silvia Cano
scano@tdvct.com

 

Case Studies