Equipment Validation

CiPharma offer a range of equipment validation services, whether it is in the laboratory or in manufacturing. Our consultants will use their experience from many sites to ensure that critical to quality parameters are considered during this process. We are experienced in what works and what doesn’t.

Equipment Validation

CiPharma staff have experience in validating reactors, ion exchange columns, evaporators, dryers, crystalisers and many other pieces of equipment. In addition there are a number of critical utility services that we routinely validate, Clean Steam Systems, Water For Injection systems and a number of HVAC and BMS / EMD systems.

Laboratory Equipment Validation

Laboratory equipment and method validation is one of our core services that we undertake for our clients. This is a time consuming process that requires specific expertise and knowledge that your company may not have. Inaccurate validation of laboratory equipment can result it being raised by an auditor as an issue during your next audit because it wasn’t done properly.

Risk Assessment

Risk-based validation is now a requirement of most regulatory agencies. Our Risk Assessment methodology will:

  • Identify the risks associated with the process, equipment and/or materials
  • Assess the impact of failure
  • Determine the likelihood of the failure happening

The risk assessment process results in a matrix document that indicates the level of qualification recommended. This, combined with a Validation Master Plan, defines the systems and equipment to be validated, sets out the number and format of the protocols and establishes the standards for acceptance criteria.

Our Validation Service includes the preparation of : Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) and Validation Summary Reports.

We can then execute the protocols, analyze and interpret the data collected, resolve any deviations noted during the execution, and prepare final validation reports. Qualification and Validation are integral steps in Quality by Design, building quality into any process or facility.

ISPE Baseline Guide for Qualifications and Commissioning

CiPharma consultants use the ISPE Baseline Guide for Commissioning and Qualification to ensure GMP-compliant documentation.