Standard Operating Procedure for Dispensing Humidity Sensitive Materials in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/039/2025
Supersedes	SOP/ELX/039/2022
Page No.	Page 1 of 8
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

This SOP outlines the procedure for the safe and controlled dispensing of humidity-sensitive raw materials in the Elixir Department, ensuring product stability, integrity, and GMP compliance.

2. Scope

This SOP applies to all activities involving the dispensing of hygroscopic or moisture-sensitive raw materials and excipients, including but not limited to citric acid, sorbitol, sodium citrate, and ascorbic acid.

3. Responsibilities

• Dispensing Operator:
  • Ensure dispensing is done in humidity-controlled areas and record environmental data.
  • Use proper tools and containers for handling sensitive materials.
• Warehouse Supervisor:
  • Ensure materials are stored in sealed containers and monitored for humidity exposure.
• QA Officer:
  • Verify environmental conditions and documentation before releasing materials.

4. Accountability

The Production Head and Warehouse In-Charge are jointly accountable for ensuring that all humidity-sensitive materials are dispensed as per this SOP and maintained under appropriate environmental conditions.

5. Procedure

5.1 Identification and Preparation

1. Identify materials labeled as “Humidity Sensitive” or “Hygroscopic” as per the approved material list.
2. Ensure containers are intact, sealed, and labeled with storage condition details.
3. Transfer materials to the dispensing booth with relative humidity (RH) below 35%.

5.2 Environmental Control Verification

1. Verify RH using a calibrated hygrometer before starting dispensing.
2. Record RH value in the Dispensing Log (Annexure-1) and ensure it is within specified limits.
3. Proceed only if RH is ≤ 35%; otherwise, delay dispensing until conditions are met.

5.3 Dispensing Activity

1. Open the container quickly and carefully. Avoid exposure to open air for more than 2 minutes at a time.
2. Weigh the material using pre-cleaned tools and place in airtight containers immediately after dispensing.
3. Seal and label both the dispensed and original containers promptly.

5.4 Labeling and Documentation

1. Label the dispensed material with:
   • Material Name
   • Batch Number
   • Quantity Dispensed
   • RH During Dispensing
   • Date
   • Dispensed By / Verified By
2. Record RH, dispensing time, and exposure duration in the logbook.

5.5 Storage and Return

1. Return unused material to desiccator-equipped storage or a low RH zone within 30 minutes.
2. Record returned quantity and time in the Material Return Register.

6. Abbreviations

• RH: Relative Humidity
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Humidity-Sensitive Material Dispensing Log (Annexure-1)
2. Certificate of Analysis (Annexure-2)
3. Approval and Release Form (Annexure-3)

8. References

• WHO TRS 986 Annex 2 – GMP Guidelines
• 21 CFR Part 211 – GMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Humidity-Sensitive Material Dispensing Log

Date	Material	Batch No.	Qty Dispensed	RH (%)	Dispensed By	Verified By
11/04/2025	Citric Acid	CA1159	1.0 kg	32%	Rajesh Kumar	Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Material	Batch No.	Test	Result	Status
Citric Acid	CA1159	Moisture Content	0.8%	Complies

Annexure-3: Approval and Release Form

Date	Material	Batch No.	Released By	Approved By	Remarks
11/04/2025	Citric Acid	CA1159	Ajay Mehta	Manoj Verma	RH Verified & Approved

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Release	New SOP Creation	QA Head
11/04/2025	2.0	RH Monitoring Integrated	Audit Compliance	QA Head