Scope

This procedure applies to all analytical instruments and equipment used within the AMD department, including but not limited to HPLC systems, balances, pH meters, UV-Vis spectrophotometers, and dissolution apparatus.

3. Responsibilities

• AMD Analyst: Ensures compliance with calibration schedules and reports overdue calibrations to the supervisor.
• QA Representative: Verifies calibration schedule updates and audit trail integrity.
• Instrumentation Coordinator: Maintains master calibration schedule, coordinates with vendors, and documents calibration certificates.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that the calibration schedules are accurate, up to date, and that no equipment is operated beyond its calibration due date.

5. Procedure

5.1 Identification of Calibrated Instruments

1. Prepare a comprehensive list of all analytical instruments used within the AMD department.
2. Assign each instrument a unique ID number, location code, and calibration frequency (monthly, quarterly, semi-annually, or annually).
3. Update the Instrument Master List (Annexure-1) after any addition or decommissioning of instruments.

5.2 Master Calibration Schedule

1. Create a centralized Master Calibration Schedule in both hardcopy and electronic format.
2. Include instrument ID, location, calibration frequency, last calibration date, due date, and responsible person.
3. Use color-coded markers or Gantt charts for visual management of due calibrations.

5.3 Execution of Calibration

1. Verify calibration standard validity before execution.
2. Use SOP-specific calibration procedures as outlined in instrument-specific SOPs (refer SOP/AMD/301–310 series).
3. Document calibration data in calibration logbooks and obtain QA review.

5.4 Handling Overdue Calibrations

1. Do not use any instrument past its calibration due date.
2. Label such instruments as “Calibration Overdue – Do Not Use.”
3. Initiate deviation if instrument was inadvertently used while overdue.
4. Perform impact assessment and record in Deviation Log (Annexure-2).

5.5 Document Control and Certificate Management

1. All calibration certificates must be signed, dated, and filed as per QA archival procedures.
2. Electronic certificates should be saved in PDF format in a restricted-access QA folder.
3. QA should verify digital signatures and lock certificate files to prevent unauthorized changes.

5.6 Review and Compliance Monitoring

1. QA shall review the Master Calibration Schedule monthly and flag any upcoming or missed calibrations.
2. Internal audits should assess compliance with this SOP during routine GMP audits.

6. Abbreviations

• AMD: Analytical Method Development
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• ID: Identification

7. Documents

1. Master Calibration Schedule – Annexure-1
2. Deviation Log Format – Annexure-2
3. Calibration Certificate Filing Checklist – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211.68 – Automatic, Mechanical, and Electronic Equipment
• USP Chapter <1058> – Analytical Instrument Qualification
• WHO Technical Report Series 957 – Quality Assurance of Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Deepa Saxena	Ravi Sethi	Dr. Harshita Goyal
Designation	Calibration Officer	QA Reviewer	Head – Analytical Method Development
Department	AMD	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Master Calibration Schedule (Excerpt)

Instrument ID	Name	Location	Last Calibration	Due Date	Status
HPLC-102	Waters Alliance HPLC	Lab-1	05/05/2025	05/11/2025	Active

Annexure-2: Deviation Log Format

Deviation ID	Description	Date	Impact	Action Taken
DEV-320-01	Calibration overdue by 5 days	10/04/2025	Low	Calibrated and impact assessed

Annexure-3: Calibration Certificate Filing Checklist

• Certificate signed and dated by calibration engineer
• Review sign-off by QA
• Unique certificate ID and instrument tag matched
• Electronic certificate saved in secure folder

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added electronic documentation process and audit trail handling	Annual SOP Review	Dr. Harshita Goyal
15/09/2022	1.0	Initial SOP Release	New SOP	QA Head