within the Gel Manufacturing Department.

3. Responsibilities

• Production Chemist: Responsible for adding preservatives as per the Batch Manufacturing Record (BMR).
• Quality Assurance (QA): Ensures that the preservative addition process complies with GMP guidelines and performs in-process verification.
• Engineering: Maintains equipment used in the addition and mixing of preservatives.

4. Accountability

The Head – Manufacturing is accountable for ensuring compliance with this SOP and that all relevant personnel are trained and follow the procedure.

5. Procedure

5.1 Equipment and Materials

• Measuring beakers or calibrated containers
• Stirring apparatus or mechanical mixer
• Stainless steel transfer vessel (if applicable)
• Personal protective equipment (PPE)
• Batch Manufacturing Record (BMR)

5.2 Pre-Addition Preparation

1. Ensure the gel base is prepared and the process is ready for preservative addition.
2. Obtain line clearance for the area and equipment from QA.
3. Cross-check preservative details (type, concentration, lot number, expiry date) against BMR.
4. Weigh or measure the preservative in a designated weighing area using a calibrated balance.

5.3 Addition of Preservatives

1. Transfer the preservative to the mixing vessel containing the gel base.
2. If the preservative is to be pre-dissolved (e.g., in purified water or propylene glycol), prepare the solution in a separate container and mix until fully dissolved.
3. Start slow stirring at 20–30 RPM and add the preservative slowly under continuous mixing to ensure uniform dispersion.
4. Continue stirring for a minimum of 15–30 minutes or as per BMR to ensure complete incorporation.

5.4 In-Process Verification

1. QA to verify the completion of preservative addition through observation and in-process sampling.
2. Record time of addition, batch number of preservative, and mixing duration in BMR.

5.5 Special Instructions

• Some preservatives may be temperature-sensitive. Follow BMR instructions for temperature control during addition (e.g., not above 40°C).
• Ensure compatibility of preservative with other formulation ingredients and adjust pH if required.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• GMP: Good Manufacturing Practices

7. Documents

1. Batch Manufacturing Record – Annexure-1
2. Preservative Addition Log – Annexure-2
3. In-Process Observation Sheet – Annexure-3

8. References

• ICH Q8 – Pharmaceutical Development
• Schedule M – GMP Requirements for Pharmaceutical Products
• Preservative Efficacy Guidelines – USP/NF

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: Batch Manufacturing Record

Document listing preservative type, quantity, and time of addition.

Annexure-2: Preservative Addition Log

Daily log recording batch number, preservative details, and responsible personnel.

Annexure-3: In-Process Observation Sheet

QA observations and comments regarding preservative incorporation.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial Issue	New SOP Release	QA Head
02/06/2025	2.0	Updated procedures for pre-dissolved preservatives	Process Standardization	QA Head