Non-GMP & cGMP API Synthesis

///Non-GMP & cGMP API Synthesis
Non-GMP & cGMP API Synthesis 2013-02-04T10:52:14+00:00

VxP Pharma offers both the expertise and the qualified facilities to synthesize API quantities from the milligram to kilogram scale, and under current Good Manufacturing Practice (cGMP) guidelines.  All production lots are closely monitored by QA/QC to ensure product consistency and regulatory compliance.

  • Synthesis procedures range from standardized to fully customized
  • We accommodate a wide range of synthesis routes
  • Qualified production equipment allows us to manage milligram to kilogram scale production under cGMP compliance

As a cGMP facility, we are committed to providing the highest quality standards in the industry.  We also understand how important it is that special care must be taken to ensure all equipment and processes are performing to specifications for every production lot.  Deviations during this particular stage can have unpredictable and sometimes devastating results.  Therefore, we pay special attention to equipment qualification and process validation to provide complete regulatory compliance for each API manufacturing project.  We have the capabilities to develop and execute tech transfer packages and validation protocols required for your projects in accordance with cGMP guidelines.

Validation Services

  • IQ/OQ/PQ/PV and utility qualification packages
  • Environmental controls and monitoring
  • Terminal sterilization procedures
  • Aseptic processing
  • Cleaning validation
  • Process validation

We are strictly “Fee for Service,” and retain no intellectual property (IP). As a result, any and all improvements to our client’s IP belong solely to that client. You can also be assured that all work is performed under strict confidentiality guidelines.

Contact us today for a free consultation with the scientific team and discover how VxP can be a valuable resource and partner for your organization.