Calibration Documents: GC System (CAL-0122)

Asset ID	CAL-0122
Equipment	GC System
Equipment Type	GC
Department	QC
Area/Location	Instrument Room
Process Use	Chromatography
Parameter	Temperature
Units	°C
Range Min	40
Range Max	400
Acceptance Criteria	±1°C
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the GC System is performed to ensure accurate temperature measurements during chromatography processes. This calibration controls risks related to data integrity, patient safety, and batch quality by ensuring that the equipment operates within specified limits.

2. Scope

• Asset ID: CAL-0122
• Equipment Name/Type: GC System / GC
• Department/Area: QC / Instrument Room
• Process Use: Chromatography
• Parameter: Temperature
• Range: 40°C to 400°C
• Units: °C
• 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 the calibration of an instrument is still valid.
• Adjustment: The process of modifying 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 output 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 expected to lie.
• Intermediate Check: A periodic 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 document results.
• QC/QA Reviewer: Review calibration documentation and results.
• Owner Department: Ensure equipment is available and in good condition for calibration.
• External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment to warm up and stabilize before calibration.
• Maintain cleanliness of the instrument and surrounding area.
• Check that the instrument is level and properly positioned.
• Verify power supply is stable and within specifications.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability statement: ISO17025
• Certificate validity check: [TBD]
• Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints. It is recommended to take three replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and standards.
2. Stabilization: Allow the GC System to reach operational temperature.
3. As Found checks and data capture: Measure temperature at defined points and record results contemporaneously.
4. Adjustment rules: If OOT is detected, escalate for adjustment as per SOP.
5. As Left verification: Confirm that the instrument is within tolerance after adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the equipment.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1°C. The error calculation formula is: Error = Observed Value – True Value. Pass/Fail logic: If the absolute value of the error is within the acceptance criteria, the calibration passes; otherwise, it fails. Rounding rule: [TBD].

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use.
• Notification & deviation initiation: Notify relevant personnel.
• 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 as per company policy.
• 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 warmed up
• Cleanliness checked
• Leveling confirmed
• Power supply stable

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-0122	GC System	GC	QC	Instrument Room	Chromatography	Temperature	°C	40 – 400	±1°C	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 40 °C
• 25% of Range: 135 °C
• 50% of Range: 220 °C
• 75% of Range: 305 °C
• Maximum: 400 °C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
40 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
135 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
220 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
305 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
400 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the GC System is clean and properly set up in the Instrument Room.
2. Stabilization: Allow the system to stabilize for at least [TBD] minutes before taking measurements.
3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
4. Calculating Error: Calculate the error for each test point using the formula: Error = Observed – Ref Value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±1°C.
6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

In the event of an Out of Tolerance (OOT) condition:

• Stop use of the GC System immediately.
• Notify the Quality Assurance (QA) department.
• 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-0122	GC System	QC	Instrument Room	Temperature	40 – 400 °C	±1°C	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow GC System to warm up for the recommended duration
• [ ] Clean the equipment as per SOP
• [ ] Level the GC System if required
• [ ] Check validity of reference standards
• [ ] Ensure logbook is ready for documentation

As Found Execution

• [ ] Record initial setpoints
• [ ] Perform repeat measurements
• [ ] Record raw data accurately
• [ ] Perform necessary calculations

OOT Immediate Actions

• [ ] Tag out the equipment
• [ ] Stop use of the GC System
• [ ] Notify the supervisor
• [ ] Document deviation
• [ ] Trigger impact review

As Left Verification

• [ ] Conduct post-adjustment checks
• [ ] Confirm all parameters are within acceptance 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, and accurate. Maintain records in compliance with GMP standards.

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Deviation Impact Assessment

Event Summary
Asset: GC System Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

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

Define Impact Window

Last Known In-Tolerance Date	Discovery Date
[TBD]	[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-0122	GC System	GC	QC	Instrument Room	[TBD]	[TBD]	[TBD]	Temperature: 40 – 400 °C	±1°C

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point	Measured Value (°C)	Pass/Fail
1	[TBD]	[TBD]
2	[TBD]	[TBD]
3	[TBD]	[TBD]
4	[TBD]	[TBD]
5	[TBD]	[TBD]

As Left Results

Test Point	Measured Value (°C)	Pass/Fail
1	[TBD]	[TBD]
2	[TBD]	[TBD]
3	[TBD]	[TBD]
4	[TBD]	[TBD]
5	[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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