PharmOut offers a range of equipment validation services, whether it’s in the laboratory or in manufacturing, we have probably seen the equipment before. Our consultants will use their experience from many sites to ensure that critical to quality parameters are considered during the equipment validation process. We’ve seen what works and what definitely doesn’t.
PharmOut 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 have been routinely asked to 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. It’s something our clients ask us to do a lot as it’s a time consuming process that requires specific expertise and knowledge that your company may not have.
It’s not worth investing the time to validate laboratory equipment only to have an auditor raise it as an issue during your next audit because it wasn’t done properly.
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, analyse 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
PharmOut consultants use the ISPE Baseline Guide for Commissioning and Qualification to ensure GMP-compliant documentation.
If you would like a quote or to ask questions, please contact us.