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Process Validation ImprovementsPharmaSys Process Validation personnel are world-wide experts in Process Validation for the biopharma industry. We've provided Process Validation services to some of the industry's most demanding clients under some of the most extreme conditions. We drive the best industry practices for process validation. Whether you are scaling up a new manufacturing process, expanding your process into additional facilities or making changes to an existing process, our engineers have the technical skills, compliance knowledge, validation experience and leadership to get your process validated with the least amount of hassles and expense to you. PharmaSys has:
FDA issues new Draft Guidance on Process Validation In November 2008, FDA published a draft guidance document on process validation intended to replace the current guidance document published in 1987. PharmaSys has published a whitepaper on the subject to in order to provide analysis of the new guidance document. You can see more at the following links: FDA's Guidance for Industry: Process Validation: General Principles and Practices, Draft Guidance, November 2008 FDA's GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION, May 1987 PharmaSys Whitepaper on Process Validation ExperiencePharmaSys has completed work in various areas of process validation such as:
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