Procedure for Incorporating Temperature-Sensitive Ingredients
| Department | Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/194 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for incorporating temperature-sensitive ingredients into ointment formulations. These ingredients require strict temperature control to prevent degradation, maintain potency, and ensure product stability.
2. Scope
This SOP applies to all personnel involved in the handling, storage, preparation, and incorporation of temperature-sensitive ingredients in the Manufacturing, Production, Quality Assurance (QA), Quality Control (QC), and Research and Development (R&D) departments.
3. Responsibilities
- Production Supervisor: Ensures compliance with temperature-sensitive ingredient handling protocols.
- Process Operator: Monitors and controls the temperature conditions during incorporation.
- QA Officer: Verifies adherence to temperature control parameters.
- QC Analyst: Conducts stability and potency testing of the ingredients post-incorporation.
- Warehouse Staff: Ensures proper storage of temperature-sensitive ingredients before usage.
4. Accountability
The Production Manager is accountable for ensuring that all temperature-sensitive ingredient incorporation procedures comply with GMP, FDA, ICH, WHO, and company policies.
5. Procedure
5.1 Selection and Storage of Temperature-Sensitive Ingredients
- Ensure that temperature-sensitive ingredients are stored at the required temperature conditions:
- Refrigerated storage: **2-8°C**
- Frozen storage: **-20°C or below**
- Controlled room temperature: **15-25°C**
- Monitor and record storage conditions in the
**Ingredient Storage Log (Annexure-1).**
5.2 Pre-Incorporation Checks
- Before incorporating, remove ingredients from storage and allow **equilibration to the required processing temperature.**
- Verify ingredient integrity, potency, and appearance before use.
- Ensure that mixing equipment is pre-calibrated to avoid thermal fluctuations.
- Document pre-incorporation checks in the **Pre-Incorporation Checklist (Annexure-2).**
5.3 Incorporation Process
- Transfer the ingredient **gradually** into the mixing vessel while maintaining the specified temperature.
- Use a controlled heating/cooling system to prevent temperature spikes.
- Maintain **gentle agitation** to ensure uniform dispersion without thermal degradation.
- Document the incorporation details in the **Ingredient Addition Log (Annexure-3).**
5.4 Post-Incorporation Quality Control
- Perform **temperature monitoring** to ensure ingredient stability.
- Conduct **potency and stability tests** to confirm that the ingredient has not degraded.
- Record all test results in the **Quality Control Testing Log (Annexure-4).**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- FDA – Food and Drug Administration
7. Documents
- Ingredient Storage Log (Annexure-1)
- Pre-Incorporation Checklist (Annexure-2)
- Ingredient Addition Log (Annexure-3)
- Quality Control Testing Log (Annexure-4)
8. References
- ICH Q8 – Pharmaceutical Development Guidelines
- FDA Guidance on Handling Temperature-Sensitive Ingredients
- WHO Guidelines on Manufacturing Quality Control
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Ingredient Storage Log
| Date | Batch No. | Storage Temperature (°C) | Condition | QA Approval |
|---|---|---|---|---|
| 01/02/2025 | OINT-3001 | 2-8°C | Acceptable | Approved |
Annexure-2: Pre-Incorporation Checklist
| Date | Batch No. | Temperature Checked | Ingredient Verified | QA Approval |
|---|---|---|---|---|
| 01/02/2025 | OINT-3001 | 5°C | Verified | Approved |
Annexure-3: Ingredient Addition Log
| Date | Batch No. | Ingredient Added | Processing Temperature (°C) | QA Approval |
|---|---|---|---|---|
| 01/02/2025 | OINT-3001 | Vitamin E | 25°C | Approved |
Annexure-4: Quality Control Testing Log
| Date | Batch No. | Stability Test Result | Potency Test Result | QA Approval |
|---|---|---|---|---|
| 01/02/2025 | OINT-3001 | Pass | 98% | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Temperature-Sensitive Ingredient Incorporation Guidelines | Regulatory Compliance | QA Head |