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Validation and Qualification Services

P.V.S. provides consulting oversight and execution services in the following validation fields covering all pharmaceutical and biopharmaceutical activities: Manufacturing, Quality Control Laboratories, Quality Assurance, Equipment and Utilities. Services also include staff training on qualification procedures and GMP requirements.

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Validation support during commissioning phase

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  • P.V.S. experts provide consultancy and support in the review and approval of engineering drawings and layouts:

    • Preliminary engineering design 

    • Material flow diagram

    • Personnel flow diagram

    • Utilities engineering design

    • Systems boundary drawings

    • Piping and instrumentation diagrams/drawings  (P&ID)

    • Isometric drawings

    • Pipe welding inspection

  • Activities related to the equipment and systems installation on site:

    • Factory Acceptance Tests (FAT)

    • Site Acceptance Tests (SAT)

    • Supervision

Equipment Validation

  • Manufacturing Equipment

    • Pharmaceutical manufacturing

    • Biopharmaceutical manufacturing

  • Laboratory Equipment
     

Performance of Thermo-mapping, Validation and Qualification

Using our certified calibration equipment and data loggers, P.V.S. experts and technicians provide execution, certification and validation documentation (IQ, OQ and PQ) for both manufacturing suites and laboratories: autoclave, incubator, refrigerator and freezer, sterilization tunnel, biosafety cabinet, chemical fume hood, High Efficiency Particulate Air (HEPA) filter, warehouse climatic mapping.

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Environmental Monitoring and Clean Rooms Control

P.V.S. offers the execution and documentation of all facility environmental control activities: particle counting, zone classification, clean rooms monitoring, microbiological monitoring, Replicate Organism Detection And Counting (RODAC) plates, contact plates, air flow/schematic diagram, HEPA filter performance and integrity.

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Cleaning Validation

  • Worst case study

  • Residual contamination limits determination for active ingredients

  • Residual contamination limits determination for cleaning agents

  • Establishing and development of cleaning analytical methods

  • Establishing of contamination limits matrices

  • Cleaning In Place – Sterilization In Place systems (CIP-SIP)

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Utilities Validation

Our experts provide consultancy for all individual utilities requiring qualification. The most important of these are Heating, Ventilation and Air Conditioning (HVAC), Air Handling Units (AHU), Water For Injection (WFI), demineralized water, Clean Steam (CS), and compressed gases.

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Shipping Validation

  • Preparation of shipping validation protocols and reports

  • Execution of shipping validation plan

  • Temperature excursions documentation

  • Evaluation of design and configuration of packaging and shippers

 

Documentation

P.V.S. prepares all GMP Validation in the early stages of a project:

  • Commissioning Master Plan (CMP)

  • Validation Master Plan (VMP)

  • Facility Design Qualification (FDQ)

  • User Requirements Specification (URS).

  • GMP-Criticality Assessment Design Qualification (DQ).

  • Installation Qualification (IQ).

  • Operational Qualification (OQ).

  • Performance Qualification (PQ).

  • Cleaning Validation Protocol and Plan (CV)

  • Process Validation (for both manufacturing process and utilities)

  • Automated and Computerized Systems Validation (CS)

  • Laboratory Information Management System (LIMS)

  • Delta V validation activities

  • Analytical Method Validation

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