The goal of this project was to provide audit services as per GMP guidelines for the client manufacturing facility.
PSC Biotech executed a 2-day GMP audit in compliance with 21 CFR 211 and 21 CFR 212. A PSC Senior Auditor performed the audit, prepped, and generated a comprehensive report of the project.
This project was completed successfully as per client specifications and in the expected time for completion.
PSC® performed calibration services for Kaye Validator 2000, SIMs, TC and Drywell, are performed in our Metrology Lab. Using the required calibration software, module, and DC voltage source along with the required temperature standards. As well as providing preventive maintenance support for their validation equipment.
PSC Biotech supported with the qualification, commissioning, validation, and other Engineering for 50L Reactor. As part of this project, PSC supported the Validation Protocol development, developing Qualification Plan, developing initial qualification documentation, execution, and final reports for different equipment and processes.
The client engaged PSC™ to initiate the validation and qualification of a AQUATHERM SWS sterilizer (Syntegon) with a chamber of approximately 2500 ft3. Laboratory and Pharmaceutical Manufacturing equipment validations play a vital role to ensure the quality and effectiveness of the equipment being used for the development of manufactured products.
PSC® executes approximately 40 CSV projects per annum across the full spectrum of systems (bench-top instruments through enterprise applications such as ERP, DCMS, and QMS.
his client uses PSC® Biotech’s professional services group to perform cGMP Compliance and Gap Analysis on their operations. The main focus was to assess the quality systems are in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices and to determine if the operation is in a “state of control “.
PSC® provided the client with non-medical technical writing support including Data Science and Regulatory Affairs focused, a Pharmacovigilance process improvement initiative, and other Clinical Science process improvement efforts.
