Compliance and Validation Services Stuff

 

Process Validation Improvements

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PharmaSys 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:

  • Comprehensive Process Knowledge

  • Extensive Regulatory Experience

  • Thorough Process Validation Skills

  • Exceptional Leadership Ability

 

FDA issues new Draft Guidance on Process Validation

In November 2008, FDA published a draft guidance document on process validation intended to replace the current guidance document published in 1987.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FDA's Guidance for Industry: Process Validation: General Principles and Practices, Draft Guidance, November 2008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

 

Experience

PharmaSys has completed work in various areas of process validation such as:

  • Bulk Chemical Process Validation

  • Solid Dosage Packaging Process Validation

  • Solid Dosage Manufacturing Process Validation

  • Sterilization Process Validation

  • Biotech Process Validation

  • Autoclave Validation

  • Bioreactors & Fermenters

  • Sterilize-in-place Process Validation

  • Annual Product Reviews

  • Ointments, Creams, Liquid Process Validation

  • Aseptic Filling Process Validation


For more information, about our Process Validation services, complete and submit the form provided below:

 

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