Validation

Equipment IQ OQ PQ Qualification and Process Validation Services

Metcal has offered IQ OQ PQ Validation Services to the biopharmaceutical and medical industry since 1996. We specialize in executing large-scale qualification projects including autoclaves, chambers, freezers, retorts, stabilities and warehouses. Our goal is to build long-term relationship with customers to support them throughout. Validation Software used by Metcal that are 100% compliant with FDA 21 CFR Part 11 and GAMP5 regulations.

Services Provided

  • Project Planning Management
  • Risk and GAP Analysis
  • IQ OQ PQ Protocol Development, Site Execution and Final Summary Report
  • Regulatory Compliance Assessments
  • Deviation Reporting and Follow Up Actions, Improvement and Preventive
  • IQ OQ PQ Validation Awareness Training

Ensuring Performance and Meeting Regulatory Requirements

  • Installation Qualification (IQ) is to verify that all the key aspects of the design, procurement, and installation are reported
  • Operational Qualification (OQ) is to verify that the system performs as intended at all anticipated operating ranges
  • Performance Qualification (PQ) is to verify that the process does what it is intended to do, in the correct anticipated manner
  • Continuous Qualification (CQ) / Re-Qualification (RQ) is to verify that the process is still performing to the standards necessary

Quality Assurance

Our team will review your validation reports, ensuring your validation reports received in utmost confidence with no errors.

  • Executed Protocols or SOPs
  • Hard and Soft Copies of Raw Data
  • Validation Personnel Training and Experience Records
  • Pre/Post Calibration Report of Validators and Data Loggers Used

Kaye Validator V.S MadgeTech Wireless Data Logger

Metcal can provide the right validator, wireless data logger to ensure your IQ OQ PQ activity in compliance throughout the entire validation process. Identifying cold and hot spots to real-time reporting and alarm notifications you will have control of your process and quality of goods 24/7. Logging all levels of temperature, relative humidity, dew point, pressure and carbon dioxide (CO2).

Retort Validation Services

Metcal is proud to provide Retort Validation Services for thermal processing of low-acid foods packaged in hermetically sealed containers. High accuracy, food-grade, wireless data loggers and general method or ball formula modelling calculations are used. Our services included retort overall performance, temperature distribution, penetration, f0 etc. Deviation discovered during sterile process will be discussed with customers for further action and improvement. Our services personnel and reports are compliant to FDA 21 CFR Part 113 requirement.

Thermal Process Assessment and Retort IQ OQ PQ Validation

Metcal can provide an on-site assessment of your compliance with FDA/USDA canning regulations. Our assessment includes product process source documentation, retort validation documentation, process delivery and process deviations. A complete report of our findings is provided upon completion, along with suggestions on how to address any issues out of compliance.

Regulatory Specialty Services

Metcal partner with a Thermal Process Authority – with vast experience and ability to handle any food safety regulatory issue. We can assist with product recalls, FDA or USDA inspections, FDA 483 reports and/or warning letters, FDA automatic detentions, FDA emergency permits, or import detentions.

Warehouse, Cold Room Mapping Services

Metcal provides Temperature and Humidity Mapping, IQ OQ PQ Validation for Warehouse, Cold Room, Heat Tunnel from 400°C to -196°C. Temperature sensitive materials can degrade at higher or lower temperature therefore it is crucial to carry out validation in those storage or processing area. 

Temperature Mapping is also crucial to determine suitable location of control sensor or data logger to be installed, representing the true value or performance. Other common temperature mapping services include refrigerators, incubators, stability chambers, controlled sample rooms, raw material storage areas, heating tunnel, conveyor oven etc.

METCAL is a Member of ISPE and PDA

The International Society for Pharmacoepidemiology (ISPE) is a non-profit international professional membership organization dedicated to promoting pharmacoepidemiology, the science which applies epidemiologic approaches to studying the use, effectiveness, value and safety of pharmaceuticals.

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information. PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high-quality, relevant education to the industry.