applies to all glassware used in the AMD department including pipettes, burettes, volumetric flasks, beakers, and measuring cylinders involved in analytical testing, method validation, and stability studies.

3. Responsibilities

• AMD Analyst: Performs glassware qualification and records data in the qualification logbook.
• QA Personnel: Reviews qualification data and approves glassware for use.
• AMD Section Head: Ensures adherence to qualification schedules and regulatory compliance.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that all glassware used in the laboratory is qualified, documented, and meets accuracy standards as per pharmacopeial and GMP requirements.

5. Procedure

5.1 Types of Glassware Covered

• Volumetric flasks (Class A or B)
• Measuring cylinders
• Beakers and conical flasks
• Burettes and pipettes
• Glass rods and funnels

5.2 Qualification Frequency

1. Initial qualification must be done before first use.
2. Requalification should be performed annually or after physical damage/repair.

5.3 Qualification of Volumetric Glassware

1. Use purified water with known density at 25°C for calibration.
2. Weigh empty glassware using a calibrated balance.
3. Fill to calibration mark and weigh again.
4. Calculate volume using water density and weight difference.
5. Compare with nominal volume; acceptance limit: ±0.2% of stated volume for Class A.

5.4 Qualification of Pipettes and Burettes

1. Use gravimetric method with calibrated balance.
2. Deliver water from pipette or burette and weigh the delivered quantity.
3. Repeat process three times and calculate average volume delivered.
4. Determine error and precision; permissible deviation should not exceed ±0.5%.

5.5 Recording and Documentation

1. Record qualification data in the Glassware Qualification Log (Annexure-1).
2. Label each qualified item with unique ID and date of qualification.
3. Maintain requalification due dates and track with master calibration schedule.

5.6 Handling of Non-Conforming Glassware

1. Glassware failing qualification shall be marked as “Rejected” and removed from service.
2. Root Cause Analysis (RCA) shall be conducted if repeated failure occurs.
3. Prepare and submit Non-Conformance Report (Annexure-2) for QA review.

6. Abbreviations

• AMD: Analytical Method Development
• QA: Quality Assurance
• RCA: Root Cause Analysis
• SOP: Standard Operating Procedure

7. Documents

1. Glassware Qualification Log – Annexure-1
2. Non-Conformance Report – Annexure-2
3. Glassware Label Template – Annexure-3

8. References

• USP General Chapter <659> – Packaging and Storage Requirements
• ICH Q6A – Specifications
• 21 CFR Part 211.63 – Equipment Design, Size, and Location
• WHO Good Practices for Quality Control Laboratories

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ankita Rawat	Deepak Shukla	Dr. Harshita Goyal
Designation	QA Chemist	QA Officer	Head – Analytical Method Development
Department	Quality Assurance	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Glassware Qualification Log

Glassware ID	Type	Volume	Qualification Date	Status
GF-319-01	Volumetric Flask	100 mL	30/05/2025	Qualified

Annexure-2: Non-Conformance Report

Describes glassware ID, observed deviation, probable cause, and corrective actions taken.

Annexure-3: Glassware Label Template

Label should include: Glassware ID, qualification date, next due date, qualified by initials.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added detailed RCA and calibration error limits	Annual SOP Review	Dr. Harshita Goyal
10/08/2022	1.0	Initial SOP Release	New SOP	QA Head