equipment qualification

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A general overview of qualifying storage equipment in a GMP environment


  • 1. Equipment Qualification Considerations When Purchasing, Designing, or Qualifying Storage Units Robert Craig Miller Senior Validation Specialist VaLogic, LLC

2. Purpose of Todays Meeting

  • Discuss the regulatory requirements driving our processes and the relationship to test scripts.
  • Discoveries encountered in Validations.
  • Q & A

3. Cradle To Grave Equipment Qualification Document Control Change Control Document Control Equipment Certification Equipment Qualification Document Control Preventive Maintenance Equipment Certification Shipper Qualification Temperature Monitoring Shipper Qualification Distribution Storage Receipt 4. Definitions

  • Acceptance Criteria The standards a product or process must meet to successfully complete a test phase or to meet delivery requirements.
  • As-Found-Data Data comparing the response of an instrument to known standards, as determined without adjustment, after the instrument is made operational.
  • Calibration:The process of adjusting an instrument or compiling a deviation chart so that its reading can be correlated to the actual value being measured.
  • Certification A documented statement, by authorized and qualified individuals, that an equipment/system validation, revalidation, qualification, re-qualification, or calibration has been performed appropriately with acceptable results.
  • Change Control A formal monitoring system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status.

5. Definitions (Continued)

  • Corrective Action An action, specified in Standard Operating Procedures, that is taken in response to information gathered from environmental monitoring data.This may be implemented whenAlertorAction Limitsare exceeded or whenTrend Analysisindicates a developing problem.
  • Critical Of or pertaining to a condition causing an abrupt change in the quality or property of an environment, process or product.
  • Critical Component Any component of a critical device thats failure to perform can be reasonably expected to cause the failure of a critical device, or to affect the devices safety or effectiveness.
  • Critical Instrumentation Those instruments which are pertinent to the proper operation, control, and recording of critical process parameters.
  • Critical Process Parameter A control parameter that has a direct relationship to the quality, safety, effectiveness, or performance of the intermediate or final product.

6. Definitions (Continued)

  • Final Report A document summarizing the results derived from the execution of a protocol.The final report shall include a conclusion, which indicates validation success or failure and designates proven acceptable ranges for all critical process parameters as determined by the execution of the validation protocol.
  • Installation Qualification The performance of documented verification that an equipment/system installation adheres to approved contract specification and achieves design criteria.
  • Operational Qualification The documented verification that the equipment/system performs per design criteria over all defined operating ranges.
  • Performance Qualification Documented verification that equipment, systems, or processes operate the way they are purported to do.This operation must be reliable and reproducible within a specified, predetermined set of parameters under normal production conditions and must be in a state of control.

7. Definitions (Continued)

  • Protocol The written and approved document of an experimental sequence of tests that, when executed as prescribed, are intended to produce documented evidence that the equipment or system does what it is designed or claims to do reproducibly.
  • Qualification Operation aimed at proving, with regard to materials, equipment, or personnel, that the required conditions are met and that they actually provide the expected results.
  • Trend Analysis Periodic review and analysis of environmental monitoring program results that can be related to time, shift, facility, etc. for patterns that may suggest underlying or developing problems.
  • Validation The overall term for establishing documented evidence through defined tests and challenges, that a system, manufacturing process, analytical method, and/or piece of equipment meets design criteria and that adequate provisions have been established to keep it in a state of control so it will produce a product that meets predetermined specifications and quality attributes.Validation can be performed prospectively, concurrently, or retrospectively.
  • Validation Master Plan The establishment of a dynamic written plan that defines the overall approach to a validation project.

8. So . . . what is Validation?

  • Legal responsibility?
  • Ethical responsibility?
  • Sound Business Practice?

9. Regulatory RequirementsValidation and Documentation

  • The FDAs 1987 guideline defines validation as:
  • Establishingdocumentedevidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting itspre-determined specificationsand quality characteristics.

10. Key ValidationDocuments

  • Validation Master Plan (VMP)
  • User Requirements
  • Functional Specifications
  • Validation Protocols
  • Standard Operating Procedures (SOPs)
  • Validation Final Reports
  • Change Control System

11. User Requirements

  • Can you identify your needs
    • In writing?
  • Musts vs. Wants
  • Simple, yet has a large impact on the design and validation processes
  • Provides basis for PQ acceptance criteria

12. Functional Specifications

  • The How Tos of meeting the User Requirements
  • Other Terms
    • User Requirement Specification
    • Purchasing Specification
    • Technical Specification
  • Provides basis for OQ and PQ acceptance criteria

13. Detailed Design

  • The hard specifics of the design
  • Detailed specifications and drawings
    • Cut sheets
    • Technical specs
    • P&IDs
    • Manufacturers documentation
  • Provides the basis for IQ

14. Design / Validation Relationship

  • User Requirements PQ
  • Functional Spec OQ
  • Detailed Design IQ
  • Build

15. Typical Things Done Summary Reports

  • Completed following protocol execution
    • Following completion of each protocol
    • May lump IQ / OQ together
  • Content
    • Defined by Validation Master Plan / SOPs
    • Clearly states whether equipment met acceptance criteria as stated in the approved protocols
    • Clearly states user limitations on the equipment, if any
    • Provides raw data obtained during the studies, along with information regarding performance of the unit during the studies, for example:
      • How long the unit maintained acceptable temperatures following power loss?
      • Hot and Cold spots in the unit

16. GMP Relevance & Risk Assessment Low High 211.68, 211.100,and 211.142 Alarms and Controls Testing Low High 211.68, 211.100,and 211.142 Alarms and Controls Testing N/A Moderate 211.68 and 211.100 Thermocouple Calibration Verification N/A Moderate Same as above Power Failure Analysis Thermal Mapping N/A High 211.63, 211.68, 211.100,and 211.142 Operating Temperature Thermal Mapping N/A Moderate Same as above Open Door Analysis Thermal Mapping N/A Moderate 211.68 and 211.100 Equipment Set-up and Thermocouple Calibration N/A High 211.63, 211.68, 211.100,and 211.142 Temperature Distribution Thermal Mapping N/A Moderate 211.68 Validation Test Equipment Verification N/A Moderate Same as above Equipment Set-up and Thermocouple Calibration High N/A 211.63 Electrical Utilities Verification Low High 211.68 and 211.100 Critical Instrumentation Calibration/Certification Verification Low High 211.68 and 211.100 Critical Instrumentation Calibration/Certification Verification Moderate Low 211.68 Validation Test Equipment Verification High Low 211.67,211.68, and 211.100 Preventive Maintenance Verification Moderate Low 211.22, 211.63, and 211.100 Installation Qualification Verification Re-qualification Operational Qualification Moderate Low 211.68 Validation Test Equipment Verification Moderate N/A 211.67, 211.68, 211.100,and 211.142 Standard Operating Procedure Verification N/A Low 211.68 and 211.100 Thermocouple Calibration Verification High N/A Same as above Electrical Utilities Verification N/A High 211.63, 211.68, 211.100,and 211.142 Operating Temperature Thermal Mapping High N/A 211.63 Environmental Conformance Ver


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