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Protocol · VAL-P07

Performance Qualification Protocol Template

PQ template covering loaded performance over extended duration under routine use.

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Purpose

To provide a template performance qualification (PQ) protocol establishing documented evidence that equipment, operated according to its SOPs under routine conditions with representative product loads, consistently performs within its specification over an extended period, and that the associated monitoring, alarm response and operational procedures are effective.

What is inside

13 sections, about 2 pages when printed.

  1. 1. Purpose
  2. 2. Scope
  3. 3. Responsibilities
  4. 4. References
  5. 5. Definitions
  6. 6. Prerequisites
  7. 7. PQ design
  8. 8. Acceptance criteria
  9. 9. Execution and reporting
  10. Deviations
  11. Data integrity
  12. Report
  13. Approval

How to complete it

  1. 1.Verify and place loggers (VAL-F08, VAL-F01); load per the SOP; record start conditions.
  2. 2.Operate per SOPs; log all events; perform challenges as planned.
  3. 3.Retrieve and post-verify loggers; download raw data; perform CHK-05 checks; analyse per VAL-P03 section 10.
  4. 4.Record results on VAL-F05; document deviations (VAL-F09).
  5. 5.Conclude on performance qualification, define conditions of use, monitoring locations, alarm limits and requalification interval (VAL-P10); QA approves and releases the equipment for use under change control.

Before you use it

  • Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
  • Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
  • Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
  • Record the document in your own document register and set its review date.

Related documents

This is an original template published by ValiTrac. It does not reproduce the text of ISO/IEC 17025 or of any accreditation body publication, and it does not by itself confer or guarantee accreditation. Customise, review and approve it before use.