Validation Consultants / Engineers Experienced in FDA, EU and PIC/S GMPs
PharmOut frequently executes validation projects on a fixed price basis or offers our experienced Validation Consultants or Validation Engineers at an hourly rate basis that work out of our office or on your site. After many years of consulting and working in validation our experts have gathered a formidable library of key project documents, ranging from Validation Master Plans, User Requirements Specifications (URS), Functional Specifications (FS) and Detailed Design Specifications, so we can comfortably and efficiently gather and document your key requirements. Our documents are designed and laid out to promote the efficient generation of qualification protocols such as IQ, OQ and PQ, or we can grab some from similar past projects. However, its not just the documents but the hands on practical in the trenches experience which is invaluable and access to colleagues with this professional knowledge.
Whether it is an existing facility, or a brand new facility manufacturing pharmaceuticals, medical devices or biologics; our engineers can navigate their way through the regulations and help you set up a compliant and practical validation approach and you can have confidence.
The regulator’s expectations of how validation is performed are continually changing, it’s no longer acceptable to have filing cabinets filled with validation documentation and at the same time have regular in-process and final product testing failures. This is apparent from the changes in EU and PIC/S Annex 15, and the FDA Risk based, Process Validation and Quality Metrics initiatives.
What this means for our Validation Consultants?
Its has been a challenge for our validation consultants to lead the discussion and provide meaningful insights into these new approaches and offer practical advice and outcomes. We regularly present and attend international conferences to remain current and shared this knowledge when we returned to the region. For example, in 2015, PharmOut trained 351 professionals in equipment qualification and process validation and has lead the discussion along side inspectors from some of the worlds most respected regulatory agencies.
PharmOut’s ‘regulatory knowledge, practically applied’ approach to compliance means that we won’t over-engineer your qualification and validation efforts, or more importantly, blow your budget.
Investigational Medicines or Product Development
Good business sense and the regulations for example Annex 13 which covers investigational medicines and product development should be controlled and developed within a GMP / GLP quality framework. This quality framework and written records are crucial to facilitate validation later, i.e. this is now know as the stage 1 of process validation.
The general expectation is that products in clinical trials should be controlled within a GLP environment, many key patient health aspects should be fully validated, i.e. sterility assurance, or computer systems validation holding medical records or analytical results. Analytical test methods must also be fully validated.
If you would like a quote or to ask questions, please contact us.