Validation/Qualification Services Print

v Commissioning/Qualification/Validation Services:

Ø  Provide Quality & Validation project Management Services

Ø  Provide Strategic Review & Planning for Departmental Infrastructure and Personnel : - Calibration & Maintenance, Engineering, QA, QC,  and Validation
Ø  Write & execute Protocols & SOPs: - MVP, VPP, IQ, OQ, PQ, PV, CLV, CV, SOPs, etc.
Ø  Advise  and Perform Equipment & Systems Validation
Ø  Advise and Perform Process Validation
Ø  Advise and Perform Cleaning Validation
Ø  Advise and Perform Utilities Validation – Purified Water Systems, Clean Air System, Nitrogen Systems, Clean Steam System, etc.
Ø  Advise and Perform Facilities Validation – HVAC Systems and Clean Rooms
Ø  Advise and Perform Computer Validation –DCS, PLC, HMI, SCADA, ERP System, TOC Analyzer, BMS System
v  Pharmaceuticals Audits Services – Advise and perform Internal and external Audits, Vendor Audits and US FDA Inspection Preparation.
v  Quality Assurance Services – Advise and perform CAPA, Deviations, Change Control, Audits, SOPs, USFDA Inspection Guidance

Validation Services Included the Following but not limited to: 

  • Develop Validation Department
  • Develop Quality Assessment and implement ISPE and ICH baseline guidelines
  • Develop and implement Master Validation Plan (MVP)
  • Write and execute protocols, write summary report, SOPs
  • Develop protocol templates (IQ, OQ, PQ, PV, CV, etc)
  • Develop risk based approach for C & Q.
  • Perform Equipment, Cleaning, Process, computer, utilities, facilities, and laboratories validation
  • Perform Gap Analysis on existing validation documents and develop remediation plan to meet  export countries regulations
  • Develop Equipment and process lifecycle strategy
  • Develop Change Control System and or remediate existing change control system based on the risked based approach
  • Develop instruments calibration procedures and provide strategy to meet export countries regulations
  • Provide hands-on Validation Training
  • Support C & Q activities to bring the plants in operations (for new and or modification of the API and Pharmaceutical plants).
  • Provide guidance on product scale-up and technology transfers.
  • Provide cGMP training to plant operators
  • Develop and implement required SOPs and other documentation.
  • Review and provide strategic planning on Validation Department Structure
  • Review and provide strategic planning on Validation personnel.
  • Perform 21 CFR Part 11 compliance on Quality Systems