SOP applies to all preservative dispensing activities carried out in the raw material dispensing area of the Gel Manufacturing Department at a pharmaceutical API and/or formulation plant.

3. Responsibilities

• Store Personnel: Responsible for issuing preservatives as per material requisition and ensuring label compliance.
• Production Chemist: Responsible for dispensing and recording preservative quantities as per batch manufacturing record (BMR).
• QA Officer: Responsible for cross-verifying and line-clearing the dispensing activity.

4. Accountability

The Head of Manufacturing and Head of Quality Assurance shall be accountable for the compliance and implementation of this SOP.

5. Procedure

5.1 Preparation Before Dispensing

1. Verify environmental parameters of the dispensing area (temperature and humidity) and ensure the area is under classified condition.
2. Ensure cleaning status labels are present on dispensing equipment and area.
3. Check that all weighing balances are calibrated and within their due dates.

5.2 Identification of Preservatives

1. Verify the preservative name, code, quantity, manufacturer, batch number, and expiry date from the raw material request form.
2. Common preservatives include Methylparaben, Propylparaben, Benzyl Alcohol, and Phenoxyethanol.

5.3 Dispensing Process

1. Use only designated Class 100/ISO 5 laminar airflow hoods for dispensing preservative powders or liquids.
2. Dispense each preservative using cleaned and dedicated scoops or pipettes.
3. Record gross and net weight in the material dispensing log.
4. Apply affixed dispensing label with details including preservative name, batch number, dispensed quantity, dispensed date, and operator initials.

5.4 Cross-Verification

1. QA officer shall verify preservative type, quantity, and identity against batch record and RM issue slip.
2. Use double-checked barcode scanning if integrated system is available.
3. Affix “Under Quarantine” label on dispensed container until approved.

5.5 Special Considerations

1. Handle hygroscopic preservatives in controlled humidity environment (below 30% RH).
2. Use nitrogen blanket for volatile or oxidation-sensitive preservatives during dispensing if applicable.

5.6 Documentation

1. Complete entries in Preservative Dispensing Record Sheet (Annexure-1).
2. Document any deviations using the Deviation Form (Annexure-2).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• RH: Relative Humidity

7. Documents

1. Preservative Dispensing Record Sheet – Annexure-1
2. Deviation Reporting Form – Annexure-2

8. References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• WHO TRS 986 – Annex 2: GMP for Pharmaceutical Products
• Schedule M – Drugs and Cosmetics Act (India)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Preservative Dispensing Record Sheet

Preservative	Batch No.	Required Qty (g/ml)	Dispensed Qty (g/ml)	Weighed By	Verified By	Date
Methylparaben	MP0125	1.50 g	1.50 g	Operator 01	QA 03	02/06/2025

Annexure-2: Deviation Reporting Form

Deviation No.	Date	Description of Deviation	Corrective Action	Reviewed By
DEV/GM/004	02/06/2025	Excess quantity weighed by 0.02 g	Re-weighed. Previous sample discarded	QA Head

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial issue	Baseline SOP for dispensing preservatives	QA Head
02/06/2025	2.0	Updated with nitrogen handling and deviation form	Regulatory updates	QA Head