Pharma-Bio Serv - Commissioning Qualification and Validation

By: Pharma-bio Serv  05/12/2011
Keywords: Risk Management, cleaning validation, software validation


  • Manufacturing Process Validation (PV): Bio, Vaccines, Pharma, Med Devices, Consumer Products
  • Packaging Process Validation (Pkg V)
  • Cleaning Validation (CV)
    • Cleanability Studies
    • Detergents Evaluation
    • Sanitizing Agents Studies
    • Recovery Studies
    • Microbial Load
    • Active Drug Solubilities and Sampling
    • Surfaces Areas and Sampling Points
    • Holding Times (Prior and Post Cleaning Process)
    • Worst Case Studies
    • Bracketing
    • New Approaches to Cleaning Validation
  • Analytical Methods Validation (MV)
  • Analytical Methods Transfer
  • Software Validation and CSV
  • 21 CFR Part 11
  • Network / IT Infrastructure Validation
  • Risk Based C&Q, Cleaning and Process Validation
  • Validation Master Plans
  • Process Support / Monitoring
  • Maintenance of Validated Status: Verification vs. Validation?  We apply QRM most recent approaches 
  • Revalidation

  Commissioning (C) and Qualification (Q)

  • Green Building Commissioning
  • Manufacturing and Packaging Equipment Qualification (IQ,OQ,PQ)
  • Design Qualification (DQ)
  • Maintenance System Qualification
  • Utilities Qualification
  • Facilities Qualification
  • FAT / SAT
  • Risk Assessment
  • Risk Management: Direct vs. Non-Direct Impact; Critical Vs. Non-Critical
  • Commissioning and Enhanced Commissioning
  • Decommissioning
  • Integrated Validation Approach
  • Suppliers / Materials
  • Personnel
  • Instrumentation

Risk-Based Approach for Qualification

  • Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)
  • Leverage testing from Commissioning (Enhanced Commissioning)
  • Eliminate redundant paperwork during qualification
  • Reduce test cases based on risk assessments
  • Interpretation and Application of new standards based on Risk Based Approach
  • Streamline practices and procedures
  • Develop risk management exercises (e.g., FMEA)

Keywords: cleaning validation, Quality Risk Management, Risk Management, Sanitizing Agents, software validation,

Other products and services from Pharma-bio Serv


Pharma-Bio Serv - Services

Once product has been transferred to manufacturing, we also support the manufacturing processes to maintain its state of control by implementing the latest practices, such as Process Excellence and Risk Management tools. Pharma-Bio Serv offers solutions to the Pharmaceutical, Biotechnology, Medical Devices, Food, and Chemical Industries by providing comprehensive range of services to ensure regulatory compliance to our clients.


Pharma-Bio Serv - Chemical and Microbiology Laboratory Support

Chemical Qualitative/Quantitative Analysis of Raw Materials, Finished Goods and Stability. SOPs development and training in Compliance with USP, EP, JP and FDA Guidelines.


Pharma-Bio Serv - Computer Systems Validation

Company Policies must be in place to establish the systems methodology to computer validation, combined with a systems based and risk management approach. Computer Systems and Software Validation is a requirement of the FDA 21 CFR and EMEA. 21 CFR Part 11 Corrective Action Plans. Development Test Plans & Report. Source Code Review and Testing.