Equipment Validation Support For Container Closure Integrity Testers
PSC provided support by performing validation on the Container Closure Integrity tester, the tester was checked for leaks on stoppered vials.
Engineering And CQV Services For Pharmaceutical Client
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.
Equipment Validation Support For MGCL Humidity Chamber
PSC provided validation and support for the qualification of a MgCl Humidity Chamber. As part of the qualification, PSC helped with developing User Requirements Specifications (URS) and Commissioning documents, developing execution/exception reports, and developing or updating relevant SOPs and other documents as needed. PSC Account managers also helped the client with project management throughout the project.
Engineering, Commissioning, Qualification And Validation Services For The Life Science Industry
The goal of this project was to provide Engineering, Commissioning, Qualification and Validation Services for equipment on the client manufacturing site.
Stability Chamber Qualification
PSC Biotech supported with the qualification, commissioning, validation and other Engineering for two stability chambers. PSC also supported in developing and maintaining all the documents related to this project. Apart from Quality assurance and technical writing support, PSC helped in smooth planning and execution of the project through its project management expertise.
International Veterinary Vaccine Registration
PSC Biotech® guided our client, a leader in the animal health industry, through the regulatory strategy for their vaccine’s international expansion by developing formats for submission of critical quality, safety, and efficacy data and authoring CTD Modules 1-5 for submission to the respective regulatory agencies.
