Standard Operating Procedure for Weighing and Dispensing of Viscosity Modifiers for Creams
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/014/2025 |
| Supersedes | SOP/CRM/014/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 05/05/2025 |
| Effective Date | 10/05/2025 |
| Review Date | 05/05/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide the guidelines for the accurate weighing and dispensing of viscosity modifiers used in the formulation of creams. This ensures that the correct amount of modifiers is dispensed, maintaining the desired viscosity and product consistency while complying with GMP standards.
2. Scope
This SOP applies to the weighing and dispensing of all viscosity modifiers used in cream formulations within the Creams Department. It covers the procedures to be followed for accurate weighing, material handling, and documentation to ensure consistency and compliance with quality standards.
3. Responsibilities
- Production Personnel: Responsible for following the procedures outlined in this SOP to ensure accurate weighing and dispensing of viscosity modifiers.
- Quality Control (QC): Verifies the accuracy of the weighing process and ensures that the viscosity modifiers are dispensed according to the formulation requirements.
- Quality Assurance (QA): Ensures that all personnel are trained and that the SOP is followed during the dispensing process. QA also reviews documentation for completeness and accuracy.
- Warehouse Personnel: Ensures that viscosity modifiers are available for dispensing and that they are correctly labeled and stored prior to use.
4. Accountability
The Head of Creams Manufacturing is responsible for ensuring that the weighing and dispensing process is carried out correctly. The QA Manager is responsible for overseeing the compliance of the process and ensuring that all necessary documentation is completed accurately.
5. Procedure
5.1 Pre-Dispensing Preparation
- Verify that the formulation recipe includes the correct viscosity modifiers and that they are available in the dispensing area.
- Ensure that the material containers are properly labeled with the correct material name, batch number, and expiry date.
- Verify that all equipment to be used for weighing (scales, containers, utensils) is calibrated, clean, and free of any contaminants.
- Review the production schedule to ensure that the correct viscosity modifiers are used for the current batch.
5.2 Weighing of Viscosity Modifiers
- Weigh each viscosity modifier using an appropriately calibrated scale. Ensure that the scale is zeroed before use to ensure accuracy.
- Ensure that the correct quantity is weighed according to the formulation recipe. Avoid over-weighing or under-weighing, as it could affect the final product’s consistency and quality.
- If the modifier is in powder form, ensure that the material is evenly distributed in the container, and avoid clumping or contamination.
- Once the material is weighed, record the quantity in the Material Dispensing Log, including the material name, batch number, weight, time, and personnel involved in the process.
- If the required quantity of viscosity modifier is not available, report it immediately to QA and ensure that no substitutions are made without approval.
5.3 Dispensing of Viscosity Modifiers
- After weighing, transfer the viscosity modifier into the appropriate container or mixer. Ensure that the material is not exposed to open air for extended periods, especially if it is sensitive to moisture or air.
- Use clean and dedicated dispensing equipment to avoid cross-contamination with other materials.
- Seal the material container securely and label it with the appropriate information, including the batch number, material name, and dispensing date.
- Any excess material should be returned to its designated storage area, provided that it has not been exposed to contaminants. Document the returned material in the Material Return Log.
5.4 Documentation of Weighing and Dispensing
- All weighing and dispensing activities should be documented in the Material Dispensing Log. This includes the material name, batch number, quantity dispensed, date and time, and personnel involved in the weighing and dispensing process.
- Any discrepancies or issues during the weighing or dispensing process must be immediately documented in the Material Discrepancy Report and reported to the QA team.
- Ensure that all documentation is signed off by the personnel involved and reviewed by the QC team to ensure completeness and accuracy.
5.5 Post-Dispensing Activities
- Once the viscosity modifier is dispensed, ensure that it is immediately transferred to the appropriate area for further processing in the cream formulation.
- If any unused viscosity modifiers are to be returned to storage, ensure that they are sealed properly and labeled correctly before being placed back in their designated storage area.
- Update the inventory system to reflect the quantity used and any remaining quantities for future use.
5.6 Handling of Discrepancies
- If any discrepancies arise during the weighing or dispensing process (e.g., incorrect quantity, mislabeled material), document the issue in the Material Discrepancy Report. The QA team should investigate the issue and take appropriate corrective actions.
- Any materials found to be incorrectly dispensed must be segregated and reviewed for impact on the batch. Corrective actions should be taken if necessary, and affected materials should not be used in production until approved by QA.
5.7 Review and Approval
- The QA team will review all dispensing records to ensure that all materials were dispensed correctly and that all documentation is complete and accurate.
- Any discrepancies in the dispensing process must be reviewed, and corrective actions should be implemented to prevent future issues.
- Once all records are verified, the batch can proceed with further processing in the production area.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
7. Documents
- Material Dispensing Log (Annexure-1)
- Material Discrepancy Report (Annexure-2)
- Corrective Action Report (Annexure-3)
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- Internal SOP for Material Handling and Dispensing
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
| Material Name | Batch Number | Quantity Dispensed | Dispensed By | Time/Date |
|---|---|---|---|---|
| Viscosity Modifier A | 12345 | 500g | John Doe | 05/05/2025 |
Annexure-2: Material Discrepancy Report
| Material Name | Batch Number | Discrepancy Description | Corrective Action Taken | Reported By | Resolution Date |
|---|---|---|---|---|---|
| Viscosity Modifier A | 12345 | Incorrect Weight Dispensed | Re-weighed, retrained personnel | John Doe | 06/05/2025 |
Annexure-3: Corrective Action Report
| Deviation | Corrective Action Taken | Responsible Person | Completion Date |
|---|---|---|---|
| Incorrect Weighing | Reviewed equipment calibration, retrained staff | John Doe | 07/05/2025 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |