Validation, Audit, and Technical Management services

Oct 7, 2022

Validation, Audit, and Technical Management

services

PSC Biotech® provided validation services for Reflex UDI project for the client.

Area: Texas
Project Type: Quality Assurance

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About this Project

OBJECTIVE

This project aimed to provide validation and Engineering support for the Reflex UDI Machine Qualification project.

SERVICES

PSC shall complete the following tasks as part of the validation and engineering support for the client, the key deliverables of this project included:

Risk Assessment
Functional Requirement Specification (FRS/FDS)
Installation and Operational Qualification (IOQ)
Development of Execution/ exceptions/ Reports
Configuration Specification
Trace Matrix (TM)
Development of SOPs and relevant forms or documents.

PSC also supported the client with project management in the execution of this project.

Project Success

This project was completed successfully as per client specifications and in the expected time for completion.

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Engineering and CQV Services for Pharmaceutical Client

Oct 6, 2022

Engineering and CQV Services for Pharmaceutical Client

PSC Biotech® provided Engineering, Commissioning, Qualification and Validation services for the client reactor at pilot facility.

Area: Texas
Project Type: Engineering, Commissioning, Qualification, Validation

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About this Project

OBJECTIVE

The goal of this project was to provide Engineering, Commissioning, Qualification and Validation Services for upgrading and qualification for 50 L Reactor at the clients Pilot Manufacturing site.

SERVICES

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. PSC also supported in developing or updating of relevant SOPs for this project. Apart from Quality Assurance and technical writing support, PSC helped in the smooth planning and execution of the project through its project management expertise.

Project Success

The client was very happy with the smooth execution of all the deliverables as well as PSC’s support with documentation as well as project management aspects within the specified timeframe.

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Equipment Validation Support for Container Closure Integrity Testers

Oct 6, 2022

Equipment Validation Support for Container Closure Integrity Testers

PSC Biotech® provided equipment validation support and Engineering support for the Container Closure Integrity Tester.

Area: Texas
Project Type: Equipment Validation and Engineering

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About this Project

OBJECTIVE

The goal of this project was to provide equipment validation support and Engineering support for one line of the container closure integrity testers for the client.

SERVICES

PSC provided support by performing validation on the Container Closure Integrity tester, the tester was checked for leaks on stoppered vials.

PSC supported with protocol development, execution and developing final reports and all relevant documentation for the Validation of the tester.

Additionally, PSC supported in planning and execution of the project through its project management expertise.

Project Success

This project has been completed meeting the client’s timeline. In Process Leak Testers (CCIT) are in production.

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Stability Chamber Qualification

Sep 29, 2022

Stability Chamber Validation and Qualification

PSC Biotech® provided Engineering, Commissioning, Qualification, and Validation Services for upgrading and qualification of stability chambers for the client.

Area: Texas
Project Type: Equipment Validation

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About this Project

OBJECTIVE

This project aimed to provide Engineering, Commissioning, Qualification and Validation Services for upgrading and qualification for two stability chambers for the client.

SERVICES

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 Success

This project was completed successfully. PSC Biotech met client and regulatory requirements, delivered results
on schedule and within budget.

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Engineering, Commissioning, Qualification and Validation Services for the Life Science Industry

Sep 29, 2022

Engineering, Commissioning, Qualification and Validation Services

PSC Biotech® provided Engineering, Commissioning, Qualification and Validation Services for upgrading and qualification for Bag Fillers for client.

Area: Texas
Project Type: Engineering, Commissioning, Qualification, Validation

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About this Project

OBJECTIVE

The goal of this project was to provide Engineering, Commissioning, Qualification and Validation Services for equipment on the client manufacturing site.

SERVICES

PSC Biotech supported the qualification, commissioning, validation, and other Engineering for Bag Filler Equipment as well as performing Installation and Operational Qualification as well as completing the Traceability Matrix for the equipment. 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 the smooth planning and execution of the project through its project management expertise.

Project Success

This project has been completed successfully as per client specifications.

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