OUR PROJECTS
Our Service Related Projects
PAST PROJECTS
PAST PROJECTS
Project Summary, Technical Writing
Oct 7, 2022
Technical Writing For San Francisco Biotech Company
PSC Biotech helps the client by generating and completing new SOPs as well as reviewing, updating and completing pre-existing SOPs for their facilities and laboratories. Examples of the SOPs that need to be developed include:
Application Management, Project Summary, Technical Support and Training Services
Oct 7, 2022
Full-Service Application Management And Technical Support
PSC Biotech support the client by providing high quality, high value application services that ensure client’s application platform evolves to support their changing business priorities. Some of the deliverables of the project include:
Audit Services, Project Summary
Oct 7, 2022
Facility GMP Audit Services
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.
Equipment Validation and Engineering, Project Summary
Oct 6, 2022
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.
Commissioning, Engineering, Project Summary, Qualification, Validation
Oct 6, 2022
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, Project Summary
Oct 6, 2022
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.
Commissioning, Engineering, Project Summary, Qualification, Validation
Sep 29, 2022
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.
Equipment Validation, Project Summary
Sep 29, 2022
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.
Project Summary, Technical Writing
Aug 11, 2022
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.
Equipment Validation, Project Summary
Apr 29, 2022
Packaging And Equipment Validation
PSC Biotech provided Validation services for various packaging components such as Cartoner, Wrapper, Case Packing, Conveyor systems with some of the key deliverables as stated below:
CSV, Project Summary
Dec 8, 2021
Validation (IQ, OQ, And PQ) Of The HVAC System Reconnection
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. The PSC® Service Lead manages account (budgets, resources) and provides CSV Subject Matter Expert input.
Auditing, Project Summary
Dec 6, 2021
CGMP Program Compliance And Gap Analysis
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 “.
Auditing, Project Summary
Dec 2, 2021
Auditing – Quality Systems And Records
This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”.
CQV and Metrology, Project Summary
Dec 2, 2021
Temperature Controlled Chamber Qualification
PSC Biotech provided CQV and Metrology services for this project. Client required rapid use of refrigerated storage trailers to handle warehouse overload. Each trailer required sensor calibration, engineering study for temperature profile, installation qualification, and operational qualification with temperature mapping.
CQV, Project Summary
Dec 1, 2021
Cleaning Validation Risk Assessment
This client utilizes PSC® Biotech’s professional services group to perform Gap Assessment on Cleaning Validation on their manufacturing equipment to maintain regulatory compliance and expectations. PSC® validation engineers evaluated the appropriate records, performed a gap analysis, and identified areas for continuous improvement.
HOW CAN WE HELP YOU
HOW CAN WE HELP YOU
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