Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

 Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

Validation (IQ, OQ, and PQ) of the HVAC system Reconnection    

Requalification of the HVAC system 

  • Area: Zhubei, Hsinchu County, Taiwan
  • Project Type: Qualification

About this Project

OBJECTIVE

Qualification protocol and summary generation, and qualification execution. 

SERVICES

PSC Biotech® delivered a detailed service quotation including personnel, transportation, and accommodation to our client, a global biopharmaceuticals development and manufacturing company located in Taiwan. With a complete understanding the client’s needs from the start, this quotation led to a useful for the verification of actual project cost.  

PSC Biotech provided exceptional professionalism in project planning and time management, qualification document designing, and the executive power of completing qualification tests and solving qualification deviations. 

The project progressed smoothly, and although operating on a tight 3-month project schedule, PSC Biotech completed this project on budget and ahead of schedule.  

Project Success

The project successfully completed ahead of schedule.

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cGMP Program Compliance and Gap Analysis

cGMP Program Compliance and Gap Analysis

A cGMP Program Compliance and Gap Analysis

Perform cGMP compliance and Gap analysis

  • Area: Saskatchewan – Saskatoon, Regina
  • Project Type: Auditing

About this Project

OBJECTIVE

Assess that client’s quality systems are in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices.

 

SERVICES

This 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 “. The PSC Biotech® Services Project Manager worked with the clients Quality team to assure that the clients specific quality concerns were incorporated into the gap analysis process. PSC® performed cGMP Program Compliance and Gap Analysis and recommended improvements and upgrades to quality systems.  PSC® prepared and advised on cGMP compliance programs including Non-conformance investigation and Corrective Action and Preventive Action procedures and the regulatory requirements.

PROJECT SUCCESS:

The project was successful, and the company is still a client of PSC®.

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 Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

Temperature Controlled Chamber Qualification

Temperature Controlled Chamber Qualification 

PSC consultants performed qualification protocol and summary generation, and qualification execution.

 

  • Area: Orange County, CA
  • Project Type: CQV and Metrology

About this Project

OBJECTIVE

To qualify multiple refrigerated trailers for controlled-temperature storage.

SERVICES

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. PSC consultants performed the calibration, ran engineering studies, wrote and executed qualification protocols, resolved deviations, and closed out reports. 

  

Equipment Used

Project Success

PSC consultants engaged quickly with client needs, adapted to shifting priorities, and delivered trailers to meet client-controlled temperature storage requirements. 

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Auditing – Quality Systems and Records

Auditing – Quality Systems and Records

Auditing – Quality Systems and Records

Perform Supplier Audits to assess the quality systems and records

  • Area: British Colombia – Vancouver and Victoria
  • Project Type: Auditing

About this Project

OBJECTIVE

Perform Supplier Audits in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices. 

 

SERVICES

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”. The PSC Biotech® Services Project Manager and Senior Supplier Auditor worked with the client’s Quality team to ensure that the client’s specific quality concerns were incorporated into the supplier audit items and process. 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 “. The PSC Biotech® Services Project Manager and Senior Supplier Auditor worked with the clients Quality team to assure that the clients specific quality concerns were incorporated into the supplier audit items and process.

PSC® appointed a Project Manager and a Senior Supplier Quality Auditor who successfully developed and maintained a supplier audit schedule in consultation with the client quality team. Audits were scheduled with vendors and executed as planned. Audit reports were issues, audit responses and corrective action and preventive action follow-up status and closeout reports were provided to the client.

PROJECT SUCCESS:

The project was a success, and the company is still a client of PSC®.

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Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment Project

PSC® Biotech’s professional services group to perform comprehensive Gap Assessment on Cleaning Validation.
  • Area: Toronto, Ontario
  • Project Type: CQV

About this Project

OBJECTIVE

Perform Cleaning Validation Risk Assessment   

SERVICES

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. Remediation tasks were associated with each of the findings and combined into a comprehensive quality risk assessment document.

PROJECT SUCCESS

The project was successful, and PSC Biotech maintains an ongoing partnership with this client.  

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