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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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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20 Years & Counting of CQV Services

Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.

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PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

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Nutritional Supplement Manufacturing Facilities

Nutritional Supplement Manufacturing Facilities

Food and Nutritional Supplement Manufacturing Facilities

Supplier Quality Audits
  • Area: Santa Monica, CA
  • Project Type: Auditing

About this Project

OBJECTIVE

Provided Audits to meet government regulation standards.

SERVICES

PSC® Provided Supplier Quality Audit services for food and nutritional supplement manufacturing facilities auditing to 21 CFR 110, 21 CFR 111 and customer quality standards.

PROJECT SUCCESS

PSC® identified and reccommended to the client our opinion concerning the compliance level at each supplier. The project was successful and left the client satisfied. Today, we still have have this organization as a client.

 

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cGMP Program Compliance and Gap Analysis

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cGMP Compliance and Gap Analysis

cGMP Compliance and Gap Analysis

cGMP Program Compliance and Gap Analysis

US FDA and European Current Good Manufacturing Practices.

Area: Santa Monica, CA
Project Type: Auditing

About this Project

OBJECTIVE

cGMP Program Compliance and Gap Analysis, as well as training clients staff on current good manufacturing practices.

SERVICES

PSC® performed cGMP Program Compliance and Gap Analysis and trained their staff on current good manufacturing practices. The audit also covered US FDA and European Current Good Manufacturing Practices. PSC® recommended improvements and upgrades to quality systems and quality systems operations. In addition, PSC® prepared and advised on Process Validation protocols, quality risk assessment procedures and cGMP compliance programs. Finally, PSC® developed European Pharmacopoeia CEP certification plan.

PROJECT SUCCESS

The project was successful and the client acheived European Union Marketing Authorization. The company is also still a client of PSC®.

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field & lab calibrations

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Audit Inspection of cGMP Facility

Audit Inspection of cGMP Facility

Audit Inspection of cGMP Manufacturing Facility

Mock Audit for Manufacturing Facility
  • Area: Massachusetts; New Hampshire
  • Project Type: Auditing

About this Project

OBJECTIVE

Preparation for FDA prior-approval.

SERVICES

PSC® performed mock FDA prior approval audit. Performed inspection of cGMP Manufacturing facility and the associated cGMP Quality Systems. PSC® developed audit response plans, corrective action and regulatory compliance plan, and trained staff. PSC®, developed cGMP training content for facilities.

PROJECT SUCCESS

The mock audit led to a successful FDA prior approval audit. The company is also still a client of ours to this day.

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annual calibration

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Provided Audits to meet government regulation standards.

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