Standard Operating Procedure for Dispensing of Preservatives in Elixir Formulations
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/038/2025 |
| Supersedes | SOP/ELX/038/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standard procedure for the safe, accurate, and contamination-free dispensing of preservatives used in the manufacturing of oral elixirs. This SOP ensures the correct quantity and handling of preservatives to maintain product stability and microbial control.
2. Scope
This SOP is applicable to all activities related to the dispensing of preservatives such as methylparaben, propylparaben, sodium benzoate, potassium sorbate, and similar agents used in the Elixir Department.
3. Responsibilities
- Dispensing Operator:
- Carry out dispensing of preservatives as per batch requirement and record the activity.
- Supervisor:
- Verify material identity, batch number, and quantity before and after dispensing.
- QA Officer:
- Ensure documentation is complete and approve materials for release to manufacturing.
4. Accountability
The Production Head is accountable for implementation and adherence to this SOP and ensuring that preservatives are dispensed accurately and documented properly.
5. Procedure
5.1 Material Verification
- Check the Material Requisition Form (MRF) and Batch Manufacturing Record (BMR) for the exact name, quantity, and batch number of the required preservative.
- Ensure the container has a green “Approved” status label and is within expiry.
- Confirm container integrity and label details:
- Material Name
- Batch Number
- Manufacturing and Expiry Dates
5.2 Dispensing Procedure
- Transfer the container to the dispensing booth or laminar airflow (LAF) area.
- Clean the container exterior with 70% IPA and dry it before opening.
- Use pre-cleaned stainless steel scoops or dispensers for solid preservatives; use calibrated pipettes or measuring cylinders for liquid preservatives.
- Weigh the required quantity using a calibrated balance and record the reading.
- Seal the original container tightly and label it as “Partially Used – To be Returned”.
5.3 Labeling and Recording
- Label the dispensed container with:
- Material Name
- Batch Number
- Quantity Dispensed
- Date
- Dispensed By and Verified By
- Make entries in the Material Dispensing Log (Annexure-1) and initial the BMR.
5.4 Quality Check and Release
- The QA officer shall:
- Review documentation and physical container.
- Approve the use of the dispensed preservative by signing the Approval Form.
- Release the dispensed material to production upon approval.
5.5 Storage and Return of Excess
- Return the unused preservative to the warehouse with a filled Material Return Form.
- Store the returned material in designated “Approved – Partially Used” storage with controlled conditions.
6. Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- IPA: Isopropyl Alcohol
7. Documents
- Material Dispensing Log (Annexure-1)
- Certificate of Analysis (Annexure-2)
- Approval and Release Form (Annexure-3)
8. References
- 21 CFR Part 211 – Good Manufacturing Practice
- WHO TRS 986 Annex 2 – GMP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Material Dispensing Log
| Date | Preservative | Batch No. | Quantity | Dispensed By | Verified By |
|---|---|---|---|---|---|
| 11/04/2025 | Sodium Benzoate | SB7788 | 0.500 kg | Rajesh Kumar | Sunita Reddy |
Annexure-2: Certificate of Analysis (CoA)
| Preservative | Batch No. | Test | Result | Status |
|---|---|---|---|---|
| Sodium Benzoate | SB7788 | Assay | 99.5% | Complies |
Annexure-3: Approval and Release Form
| Date | Preservative | Batch No. | Released By | Approved By | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | Sodium Benzoate | SB7788 | Ajay Mehta | Manoj Verma | Approved for Batch ELX-205 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Issuance | New SOP | QA Head |
| 11/04/2025 | 2.0 | Updated Procedure and Annexures | Standardization and Audit Compliance | QA Head |