Calibration Documents: Balance Calibration Weight 200 g (CAL-0337)

Asset ID	CAL-0337
Equipment	Balance Calibration Weight 200 g
Equipment Type	Standard Weight
Department	Calibration Lab
Area/Location	Metrology
Process Use	Mass standard
Parameter	Weight
Units	g
Range Min	200
Range Max	200
Acceptance Criteria	Class F1/E2
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Balance Calibration Weight 200 g is performed to ensure accuracy in mass measurements, which is critical for maintaining patient safety, batch quality, and data integrity in pharmaceutical processes. Accurate weight measurements directly impact the formulation of products, ensuring compliance with regulatory standards and minimizing risks associated with incorrect dosing.

2. Scope

• Asset ID: CAL-0337
• Equipment Name/Type: Balance Calibration Weight 200 g / Standard Weight
• Department/Area: Calibration Lab / Metrology
• Process Use: Mass standard
• Parameter: Weight
• Range: 200 g
• Units: g
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of an instrument against a known standard.
• Verification: The process of confirming that an instrument meets specified requirements.
• Adjustment: The act of modifying an 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 specified acceptance criteria.
• Drift: The gradual change in an instrument’s performance over time.
• Traceability: The ability to trace the history, application, or location of an item through 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 verification of an instrument’s performance between scheduled calibrations.

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 for compliance.
• Owner Department: Ensure equipment is available and maintained.
• External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment to warm-up/stabilize as per manufacturer recommendations.
• Maintain cleanliness of the calibration area and equipment.
• Check leveling of the balance before calibration.
• Verify power supply stability and functionality.

7. Standards & Tools

• Reference Standards Required: Calibration weights certified to Class F1/E2.
• Traceability Statement: Calibration is traceable to ISO17025.
• Certificate Validity Check: Ensure calibration certificates are current and valid.
• Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be 5, including endpoints and midpoints. It is recommended to take 3 replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary calibration weights and documentation.
2. Stabilization: Allow the balance to stabilize in the calibration environment.
3. As Found checks and data capture: Record initial weight measurements using the calibration weights.
4. Adjustment rules: If OOT is found, escalate for adjustment as per SOP; do not adjust without approval.
5. As Left verification: After adjustments, re-check the weights and record results.
6. Labeling + documentation completion: Label the equipment with calibration status and complete all documentation contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the calibration of the Balance Calibration Weight 200 g is Class F1/E2. The error calculation formula is:

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

Pass/Fail logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use until resolved.
• Notification & deviation initiation: Notify QA and initiate a deviation report.
• Impact assessment trigger: Assess impact on results/batches within the defined impact window.
• Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
• QA disposition: [TBD]

12. Records & Retention

• Logbook entries: Document all calibration activities in the logbook.
• Calibration report/certificate filing: Maintain records of calibration certificates.
• 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 verified
• Equipment cleaned and leveled
• Calibration weights checked for validity
• 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-0337	Balance Calibration Weight 200 g	Standard Weight	Calibration Lab	Metrology	Mass standard	Weight	g	200 – 200	Class F1/E2	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Min: 200 g
• 25%: 200 g
• 50%: 200 g
• 75%: 200 g
• Max: 200 g

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
200 g	200 g	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the calibration weight is clean and free from contaminants.
2. Stabilization: Allow the calibration weight to acclimate to the environmental conditions for at least [TBD] minutes.
3. Performing Readings: Take three replicate readings at each test point and record the values.
4. Calculating Error: Calculate the error for each observed value against the reference value.
5. Evaluation: Compare the calculated errors against the acceptance criteria.
6. Documentation: Complete the results table and ensure all data is recorded accurately.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

• Stop use of the equipment.
• 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
____________________ / Date: ___________	____________________ / Date: ___________	____________________ / Date: ___________

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Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0337	Balance Calibration Weight 200 g	Calibration Lab	Metrology	Weight	200 g	Class F1/E2	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up for the required duration
• [ ] Clean the calibration weight and surrounding area
• [ ] Level the balance as per manufacturer instructions
• [ ] Check validity of reference standards
• [ ] Ensure calibration logbook is ready for documentation

As Found Execution

• [ ] Set the calibration weight to specified setpoints
• [ ] Perform repeat measurements for consistency
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment if out of tolerance (OOT)
• [ ] Stop use of the equipment immediately
• [ ] Notify the QA department of the OOT condition
• [ ] Document the deviation in the logbook
• [ ] Trigger an impact review as per SOP

As Left Verification

• [ ] Conduct post-adjustment checks to confirm accuracy
• [ ] Ensure all measurements are within specified limits

Documentation & Closure

• [ ] Update equipment label with calibration details
• [ ] Attach calibration certificate to the logbook
• [ ] Obtain reviewer sign-off on calibration results
• [ ] Update next due date for calibration

Data Integrity (ALCOA+): Ensure all data recorded is attributable, legible, contemporaneous, original, and accurate.

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Deviation Impact Assessment

Event Summary
Asset: Balance Calibration Weight 200 g 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

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-0337	Balance Calibration Weight 200 g	Standard Weight	Calibration Lab	Metrology	[TBD]	[TBD]	[TBD]	Weight / 200 g / g	Class F1/E2

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point	Measurement (g)
1	[TBD]
2	[TBD]
3	[TBD]
4	[TBD]
5	[TBD]

As Left Results

Test Point	Measurement (g)
1	[TBD]
2	[TBD]
3	[TBD]
4	[TBD]
5	[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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