Commissioning and Qualification of Equipment
PharmOut offers a range of equipment commissioning and qualification services. Whether it’s in the laboratory or in manufacturing, it is highly likely that we have seen the equipment before or at least something similar! Our consultants will use their experience from many sites and projects to ensure that critical quality attributes CQAs and Critical Process Parameters CPPs are identified and considered during the equipment validation. We’ve seen what works and what doesn’t and can help stop you from making any unnecessary and costly mistakes.
Process Equipment Validation
The PharmOut team has led the discussions in Australia, Hong Kong and New Zealand to innovate Process and Equipment Validation, through a number of validation forums since 2011, soon after the draft Process Validation guidance was issued by the FDA.
PharmOut has also led the discussion on cleaning validation and offers a cleaning validation service.
Laboratory Equipment Validation
The most frustrating thing companies can find is when they siphon time and money into performing a slap-dash equipment validation – only to have an auditor raise it as an issue during the next audit because it wasn’t done properly!
PharmOut has a number of consultants who are specialists in laboratory equipment validation 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 sometimes companies do not have.
Risk-based validation has long been a regulatory requirement, however we feel that to accurately assess risk, the Quality Target Product Profile and associated Critical Quality Attributes must be understood.
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 : Project and Validation Master Plans, User Requirement Specifications (now and explicit regulatory requirements), Design Review/Qualification, 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 Commissioning and Qualification
PharmOut consultants use, amongst other documents, the ISPE Baseline Guide for Commissioning and Qualification to ensure GMP compliance and the manufacture of safe and effective medicines and devices.
If you would like a quote or to ask questions, please contact us.