Standard Operating Procedure for Handling of Intermediate Product During Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/085/2025 |
| Supersedes | SOP/ELX/085/2022 |
| 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 standardized procedure for handling intermediate product during various stages of elixir manufacturing to prevent contamination, maintain product integrity, and ensure traceability.
2. Scope
This SOP is applicable to all intermediate bulk products generated during the manufacturing process of elixirs in the Elixir Department before the final product stage.
3. Responsibilities
- Production Operator:
- Label, cover, transfer, and store intermediate products appropriately.
- Production Supervisor:
- Ensure intermediate products are handled according to predefined holding conditions.
- Verify documentation and time tracking.
- QA Officer:
- Review holding records, verify product status, and authorize further processing.
4. Accountability
The Head of Production is accountable for ensuring that all intermediate products are handled as per this SOP and that no mix-up, contamination, or deterioration occurs.
5. Procedure
5.1 Identification and Labeling
- Immediately after completion of a processing
step (e.g., mixing, pH adjustment), label the intermediate product with a “INTERMEDIATE PRODUCT” tag (Annexure-1).
The label must include:
- Product Name
- Batch Number
- Stage (e.g., Post-Mixing)
- Date and Time
- Operator Initials
5.2 Handling and Storage
- Transfer the intermediate product to designated storage or holding tanks using sanitized transfer lines.
- Cover tanks securely and maintain nitrogen blanketing if required for volatile products.
- Maintain holding conditions such as:
- Temperature: as per product specification
- Duration: not to exceed approved hold time (typically ≤48 hours)
5.3 Documentation and Time Tracking
- Record start and end time of holding in the Intermediate Holding Log (Annexure-2).
- Any deviation in holding time must be reported immediately and evaluated for product impact.
5.4 Release for Next Step
- QA shall perform visual inspection and review holding time and conditions.
- Once verified, QA will sign off the Intermediate Holding Log for batch release to the next manufacturing stage (e.g., filtration, flavor addition).
5.5 Precautions
- Do not mix intermediate batches unless approved by QA.
- Protect intermediate product from direct light, dust, and personnel traffic.
- Never use unclean or unvalidated equipment for holding or transfer.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- Intermediate Product Tag (Annexure-1)
- Intermediate Holding Log (Annexure-2)
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.111 – Time Limitations on Production
- WHO TRS 1010 – GMP for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Intermediate Product Tag
| Product Name | Batch No. | Stage | Date | Time | Operator | Status |
|---|---|---|---|---|---|---|
| Paracetamol Elixir | ELX-1024 | Post-Mixing | 11/04/2025 | 02:00 PM | Rajesh Kumar | INTERMEDIATE |
Annexure-2: Intermediate Holding Log
| Date | Batch No. | Tank ID | Start Time | End Time | Holding Duration | QA Release |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1024 | ST-03 | 02:00 PM | 04:30 PM | 2.5 Hours | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Enhanced traceability and holding log | GMP Audit Recommendation | QA Head |