UPLC System (CAL-0121) – Calibration Documents

Calibration Documents: UPLC System (CAL-0121)

Asset ID CAL-0121
Equipment UPLC System
Equipment Type UPLC
Department QC
Area/Location Instrument Room
Process Use Chromatography
Parameter Flow rate
Units mL/min
Range Min 0.01
Range Max 2
Acceptance Criteria ±2%
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 UPLC System is performed to ensure the accuracy of the flow rate parameter, which is critical for maintaining patient safety and ensuring batch quality in chromatographic processes. Accurate measurements are essential for data integrity, as any deviations could lead to erroneous results affecting product quality.

2. Scope

  • Asset ID: CAL-0121
  • Equipment Name/Type: UPLC System / UPLC
  • Department/Area: QC / Instrument Room
  • Process Use: Chromatography
  • Parameter: Flow rate
  • Range: 0.01 to 2 mL/min
  • Units: mL/min
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of configuring an instrument to provide a result for a sample within an acceptable range.
  • Verification: The process of confirming that an instrument is operating within specified limits.
  • Adjustment: The act of altering an instrument to bring it into compliance with specified standards.
  • As Found: The condition of the instrument prior to any adjustments.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement exceeds the acceptance criteria.
  • Drift: The gradual change in an instrument’s performance 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 check performed between calibrations to ensure continued accuracy.

4. References

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

5. Responsibilities

  • Technician/Metrology: Perform calibration and maintain records.
  • QC/QA Reviewer: Review calibration results and documentation.
  • Owner Department: Ensure compliance with calibration schedules.
  • External Service Provider: Conduct external calibration as per requirements.

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 instrument and surrounding area.
  • Check leveling of the instrument.
  • Verify power supply stability and functionality.
See also  Balance Calibration Weight 500 g (CAL-0338) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all reference standards are within valid calibration dates.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

The calibration will follow an As Found then As Left logic:

  • Minimum number of points: At least 5 points including endpoints and midpoints within the range of 0.01 to 2 mL/min.
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the UPLC System to stabilize for [TBD] minutes.
  3. As Found checks and data capture: Record initial flow rate readings at defined points.
  4. Adjustment rules: If OOT is detected, follow adjustment protocols; otherwise, escalate to QA.
  5. As Left verification: Confirm that the instrument is within acceptance criteria after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the instrument accordingly.

Record raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for flow rate is ±2% of the set point.

Error calculation formula: Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail Logic: If the error is within ±2%, the calibration passes; otherwise, it fails.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration as necessary.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records in accordance with company policy.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, technician name, and 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 checked
  • Equipment warm-up completed
  • Cleanliness verified
  • Leveling confirmed
  • Power supply checked

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-0121 UPLC System UPLC QC Instrument Room Chromatography Flow rate mL/min 0.01 – 2 ±2% 365 days External ISO17025
See also  Manometer (U-tube/Digital) (CAL-0078) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0.01 mL/min
  • 25% of Range: 0.5075 mL/min
  • 50% of Range: 1.005 mL/min
  • 75% of Range: 1.5025 mL/min
  • Maximum: 2 mL/min

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0.01 mL/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
0.5075 mL/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
1.005 mL/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
1.5025 mL/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2 mL/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the UPLC system is clean and calibrated according to the manufacturer’s specifications.
  2. Stabilization: Allow the system to stabilize for at least [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate measurements at each test point for accuracy.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±2%.
  6. Documentation: Record all findings in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

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

Approvals

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

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0121 UPLC System QC Instrument Room Flow rate 0.01 – 2 mL/min ±2% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure UPLC system has been warmed up for the required time
  • [ ] Clean the equipment as per SOP
  • [ ] Level the instrument appropriately
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Record initial setpoints for flow rate
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for analysis
See also  Turbidity Meter (CAL-0232) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance
  • [ ] Stop use of the UPLC system immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review process

As Left Verification

  • [ ] Conduct post-adjustment checks to confirm settings
  • [ ] Ensure all parameters are within acceptance limits

Documentation & Closure

  • [ ] Update equipment label with new calibration date
  • [ ] Attach calibration certificate to documentation
  • [ ] Obtain reviewer sign-off on calibration report
  • [ ] Update next due date for calibration

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, and Accurate. Maintain complete traceability throughout the calibration process.

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Deviation Impact Assessment

Field Details
Asset UPLC System
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

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

Define Impact Window

Field Details
Last Known In-Tolerance Date [TBD]
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

Summary of investigation findings: [TBD]

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-0121 UPLC System UPLC QC Instrument Room [TBD] [TBD] [TBD] Flow rate: 0.01 – 2 mL/min ±2%

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measured Value (mL/min) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (mL/min) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ___________

Checked by: ____________________ Date: ___________

Approved by: ____________________ Date: ___________

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