Chemistry,  Manufacturing, and Controls 

An essential requirement for product approval is the ability to manufacture commercial product. GXPQS consultants have a proven track record ensuring CMC requirements are in place for production operations that meet approval inspection expectations. From the Quality System SOPs necessary for internal production operations, to oversight of CMO and contract laboratory manufacturing and testing, GXPQS consultants have you covered.

Services:

  • GMP and QSR implementation and oversight. 

  • Preparation of Engineering / Production Facility Plans. 

  • QC specifications and test method development and validation. 

  • Preparation and/or review of manufacturing documentation including master production records (MPRs), QC testing records, stability and qualification/validation protocols and reports, forms and SOPs. 

  • Author written procedures for the manufacturing process, including instructions for equipment use, environmental monitoring, calibration and maintenance of equipment, etc. 

  • cGMP compliance audits of systems, facilities, and process/operations of suppliers, vendors, and contractors, CMOs including, GMP testing facilities, API and finished product manufacturing facilities, labeling and packaging facilities, holding and distribution facilities/clinical supplies. 

  • Review and approval of executed production records (EPRs), QC data and certificate of analysis, product disposition, development and stability reports. 

  • QA Material / Product Disposition 

  • QA monitoring and controls development and implementation in order to reduce the number of defects and improve levels of quality and optimize efficiency. 

  • Preparation/review of CMC sections of regulatory submissions (i.e. INDs, NDAs, BLA’s, DMFs, etc.). 

  • Stability Protocol evaluation and review of results and reports. 

  • Production staff training on quality procedures, protocols, and documentation. 

  • Investigation when measurements are found to deviate from standards.

  • Leadership and oversight of validation activities

Contact Us

(713)-882-1987

info@gxpqsllc.com

8000 Research Forest Drive Ste.115-32 

The Woodlands, Texas 77382