maintain compliance with GMP and WHO guidelines.

2. Scope

This SOP is applicable to all personnel handling hygroscopic raw materials—such as sorbitol, propylene glycol, and magnesium chloride—used in the preparation of gel formulations in the Gel Manufacturing department.

3. Responsibilities

• Dispensing Operator: Handles hygroscopic materials following precautions outlined in this SOP.
• Supervisor: Ensures materials are processed promptly and verifies handling protocol is followed.
• QA Officer: Performs environmental monitoring and ensures records are complete and accurate.

4. Accountability

The Head of Manufacturing is accountable for ensuring the implementation of this SOP and adherence to material-specific handling requirements.

5. Procedure

5.1 Identification of Hygroscopic Materials

1. Refer to the Material Safety Data Sheet (MSDS) and material specifications to identify hygroscopic behavior.
2. Label materials with “Hygroscopic – Handle with care” stickers immediately upon receipt and inspection.

5.2 Environmental Controls

1. Maintain temperature at 20–25°C and relative humidity (RH) below 40% in storage and weighing areas.
2. Weighing of hygroscopic materials should only be conducted inside a designated dry room or under a laminar airflow equipped with dehumidifiers.
3. Monitor and record environmental parameters every hour using the Environmental Log Sheet (Annexure-1).

5.3 Handling Procedure

1. Plan material weighing in advance to minimize exposure time.
2. Use only clean, dry, and tightly-sealable containers for weighing and transfer.
3. Immediately reseal material containers after taking the required quantity.
4. Avoid exposing materials to air for more than 3 minutes per weighing operation.

5.4 Use of Desiccants

1. Maintain opened primary containers in a desiccator or sealed with silica gel pouches until complete consumption.
2. Use moisture barrier bags for intermediate storage if material is to be used in multiple shifts.

5.5 Labeling and Documentation

1. Apply labels clearly indicating “Hygroscopic” along with date and time of weighing.
2. Document the material name, batch number, quantity, balance ID, weighing time, and exposure duration in the Hygroscopic Material Log (Annexure-2).

5.6 Material Transfer

1. Immediately transfer weighed material to the manufacturing area using sealed transfer bins.
2. Do not store partially used materials unless specifically authorized by QA with documented justification.

5.7 Disposal of Damaged or Moisture-Affected Materials

1. Any material exhibiting signs of caking, lumping, or moisture absorption must be quarantined.
2. QA shall inspect the sample and decide on reprocessing or destruction, as per site SOP.
3. Complete the Non-Conformance Form (Annexure-3) and update inventory accordingly.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• MSDS: Material Safety Data Sheet
• RH: Relative Humidity

7. Documents

1. Environmental Log Sheet – Annexure-1
2. Hygroscopic Material Log – Annexure-2
3. Non-Conformance Form – Annexure-3

8. References

• WHO Technical Report Series No. 986 – GMP Guidelines
• ICH Q7 – Good Manufacturing Practice for APIs
• Schedule M – Indian GMP Regulations

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: Environmental Log Sheet

Date	Time	Temperature (°C)	RH (%)	Checked By
02/06/2025	10:00 AM	23	36	Vinay Pawar

Annexure-2: Hygroscopic Material Log

Material Name	Batch No.	Quantity (kg)	Exposure Time (min)	Weighed By	Date
Sorbitol	SRB0525	15	2.5	Rajesh Kumar	02/06/2025

Annexure-3: Non-Conformance Form

Date	Material	Issue Noted	Disposition	QA Decision
02/06/2025	Propylene Glycol	Lumping	To be discarded	Approved

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
02/06/2025	2.0	Revised procedures, added annexures for compliance tracking	Annual Review	QA Head