Stability Chamber Controller Display RH (CAL-0183) – Calibration Documents

Calibration Documents: Stability Chamber Controller Display RH (CAL-0183)

Asset ID CAL-0183
Equipment Stability Chamber Controller Display RH
Equipment Type RH Controller
Department Stability
Area/Location Stability Room
Process Use ICH stability
Parameter Humidity
Units %RH
Range Min 10
Range Max 90
Acceptance Criteria ±3%RH
Calibration Frequency (days) 365
Calibration Type External
Traceability ISO17025

Table of Contents

  1. Calibration SOP
  2. Calibration Protocol
  3. Calibration Checklist
  4. Deviation Impact Assessment
  5. Calibration Certificate

Calibration SOP

1. Purpose

The calibration of the Stability Chamber Controller Display RH is performed to ensure the accuracy of humidity measurements within the stability room. This is critical for maintaining compliance with ICH stability guidelines, ensuring patient safety, batch quality, and data integrity. Accurate humidity control is essential to prevent product degradation and ensure reliable stability testing results.

2. Scope

  • Asset ID: CAL-0183
  • Equipment Name/Type: Stability Chamber Controller Display RH / RH Controller
  • Department/Area: Stability / Stability Room
  • Process Use: ICH stability
  • Parameter: Humidity
  • Range: 10%RH to 90%RH
  • Units: %RH
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement instrument to bring it into compliance with specified standards.
  • As Found: The condition of the instrument prior to any adjustments being made.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the defined acceptance criteria.
  • Drift: The gradual change in the output of a measurement instrument over time.
  • Traceability: The ability to verify the history, location, or application of an item by means of documented recorded identification.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is asserted to lie.
  • Intermediate Check: A quick assessment of the instrument’s performance between full calibrations.

4. References

  • Company Metrology SOP [TBD]
  • ISO/IEC 17025 traceability via calibration certificates
  • ALCOA+ principles

5. Responsibilities

  • Technician/Metrology: Responsible for performing the calibration and documenting results.
  • QC/QA Reviewer: Responsible for reviewing calibration documentation and ensuring compliance.
  • Owner Department: Responsible for maintaining the equipment and ensuring timely calibration.
  • External Service Provider: Responsible for conducting external calibrations as per the calibration type.
See also  TOC Analyzer Online (CAL-0097) - Calibration Documents

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize as per manufacturer recommendations.
  • Maintain cleanliness of the calibration area and equipment.
  • Ensure equipment is level and stable.
  • Check power supply for stability and reliability.

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (10%RH, 90%RH) and midpoints (50%RH).
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the equipment to stabilize in the calibration environment.
  3. As Found checks and data capture: Record initial readings at defined points.
  4. Adjustment rules: If OOT is found, follow escalation procedures for adjustment.
  5. As Left verification: Confirm readings post-adjustment.
  6. Labeling + documentation completion: Ensure all records are filled out accurately.

Record raw observations contemporaneously to ensure ALCOA+ compliance.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±3%RH

Error calculation formula: Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within acceptance criteria, the test point passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records for audit purposes.
  • e-Records if applicable: [TBD]
  • Label content requirements: Calibrated date, due date, by whom, status.

13. Annexures

Annexure A: Calibration Data Sheet

Test Points Reference Observed Error Acceptance Pass/Fail As Found As Left
[TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Annexure B: Quick Checklist

  • Environmental controls verified
  • Equipment stabilized
  • Calibration tools checked
  • Documentation prepared

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

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Calibration Protocol

Calibration Protocol

Protocol ID Asset ID Equipment Name Equipment Type Dept Area Process Use Parameter Units Range Acceptance Criteria Frequency Calibration Type Traceability
[TBD] CAL-0183 Stability Chamber Controller Display RH RH Controller Stability Stability Room ICH stability Humidity %RH 10 – 90 ±3%RH 365 days External ISO17025
See also  Anemometer (HVAC) (CAL-0250) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 10% RH
  • 25%: 27.5% RH
  • 50%: 50% RH
  • 75%: 72.5% RH
  • Maximum: 90% RH

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
10% RH 10% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]
27.5% RH 27.5% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]
50% RH 50% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]
72.5% RH 72.5% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]
90% RH 90% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the stability chamber is clean and operational.
  2. Stabilization: Allow the chamber to stabilize at the target humidity level for at least 2 hours.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the errors to the acceptance criteria.
  6. Documentation: Record all observations in the results table.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • Open a deviation report.
  • Quarantine impacted results window: [TBD]
  • Await QA decision on further actions.

Approvals

Prepared Reviewed Approved
[Signature/Date] [Signature/Date] [Signature/Date]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0183 Stability Chamber Controller Display RH Stability Stability Room Humidity 10%RH – 90%RH ±3%RH 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the equipment as per cleaning procedure
  • [ ] Ensure equipment is level
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Record initial setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review
See also  Graduated Cylinder 100 mL (CAL-0043) - Calibration Documents

As Left Verification

  • [ ] Perform post-adjustment checks
  • [ ] Confirm all parameters are within specified limits

Documentation & Closure

  • [ ] Update equipment label
  • [ ] Attach calibration certificate
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in logbook

Data Integrity (ALCOA+): Ensure all data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

Out of Tolerance (OOT) Handling: Follow established procedures for OOT situations to ensure compliance and integrity of the calibration process.

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Deviation Impact Assessment

Event Summary
Asset: Stability Chamber Controller Display RH
Date: [TBD]
Discovered By: [TBD]
Document References: [TBD]
As Found Results Summary: [TBD]

Immediate Containment Checklist

  • Stop use of the affected equipment
  • Label/tag the equipment as out of tolerance
  • Segregate impacted work

Define Impact Window

Last known in-tolerance date: [TBD] to discovery date: [TBD]

Product/Batch/Test Impact Review

Batch/Study/Report ID Results Potentially Impacted Re-test/Re-weigh Decision
[TBD] [TBD] [TBD]

Data Integrity Review Prompts (ALCOA+)

  • Attributable: [TBD]
  • Legible: [TBD]
  • Contemporaneous: [TBD]
  • Original: [TBD]
  • Accurate: [TBD]
  • Complete: [TBD]
  • Consistent: [TBD]
  • Enduring: [TBD]
  • Available: [TBD]

Risk Assessment

Severity Probability Detectability Rationale Overall Risk
[TBD] [TBD] [TBD] [TBD] [TBD]

Investigation Summary

Root Cause: [TBD]

CAPA Plan

Action Owner Due Date Effectiveness Check
[TBD] [TBD] [TBD] [TBD]

QA Disposition

Release/Hold/Retest/Recall Triggers: [TBD]

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Calibration Certificate

Certificate No: [TBD]

Date: [TBD]

Next Due Date: [TBD]

Asset Details

Asset ID Equipment Name Equipment Type Dept Area Make/Model Serial No Location Parameter/Range/Units Acceptance Criteria
CAL-0183 Stability Chamber Controller Display RH RH Controller Stability Stability Room [TBD] [TBD] [TBD] Humidity: 10 – 90 %RH ±3%RH

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] Traceability to ISO17025

Results

As Found Results

Test Point Measured Value (%RH) Pass/Fail
10%RH [TBD] [TBD]
30%RH [TBD] [TBD]
50%RH [TBD] [TBD]
70%RH [TBD] [TBD]
90%RH [TBD] [TBD]

As Left Results

Test Point Measured Value (%RH) Pass/Fail
10%RH [TBD] [TBD]
30%RH [TBD] [TBD]
50%RH [TBD] [TBD]
70%RH [TBD] [TBD]
90%RH [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

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