Standard Operating Procedure for Dispensing Raw Materials for Cream Formulations
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/002/2025 |
| Supersedes | SOP/CRM/002/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 05/03/2025 |
| Effective Date | 10/03/2025 |
| Review Date | 05/03/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the accurate dispensing of raw materials in the formulation of creams. This SOP ensures that raw materials are measured precisely, following quality and regulatory standards, to prevent formulation errors and ensure product consistency and safety.
2. Scope
This SOP applies to all raw materials involved in the formulation of creams within the Creams Department. It includes procedures for selecting, weighing, measuring, and transferring raw materials during the dispensing process.
3. Responsibilities
- Warehouse Personnel: Ensures the correct raw materials are provided for the formulation process and are accurately labeled.
- Production Team: Responsible for the precise measurement and handling of raw materials during the dispensing process according to the formulation recipe.
- Quality Control (QC): Verifies the quantities of raw materials dispensed and ensures adherence to the formulation specifications and quality standards.
- Quality Assurance (QA): Oversees the implementation of this SOP and ensures compliance with good manufacturing practices (GMP) during the dispensing process.
4. Accountability
The Head of Creams Manufacturing is accountable for ensuring the correct implementation of this SOP across all dispensing activities. Compliance with the dispensing procedures is ultimately the responsibility of the Quality Assurance (QA) Manager.
5. Procedure
5.1 Preparation for Dispensing
- Before dispensing, verify that all raw materials required for the cream formulation are available and meet the necessary specifications. Check the Material Identification Log to ensure that the correct batch and lot numbers are listed.
- Review the formulation recipe to confirm the required quantities of each material. Ensure that the materials match the specifications listed in the recipe, and confirm the correct batch numbers and expiration dates.
- Prepare the dispensing area to ensure it is clean, organized, and free from contaminants. Ensure that all equipment used for dispensing (e.g., scales, measuring containers) is calibrated and in good working condition.
5.2 Dispensing of Raw Materials
- Begin by selecting the appropriate dispensing equipment, such as a balance, scale, or volumetric equipment, depending on the nature of the raw material. Ensure that all equipment is clean and calibrated before use.
- Using the formulation recipe, weigh or measure the required amount of each material. Ensure that the correct raw material is used, following the exact specifications and quantities outlined in the recipe. If liquid materials are involved, use volumetric measures to ensure accuracy.
- If there is any discrepancy in the quantity being dispensed, stop the process immediately and notify the QA team for further instructions. Any deviation from the prescribed amounts must be documented and investigated.
- Once the material has been dispensed, transfer it to the designated container for the formulation. Ensure that no material is spilled during the transfer process, and if any spillage occurs, it should be cleaned immediately following the proper procedures for handling the waste.
5.3 Handling of Dispensed Materials
- Once dispensed, materials should be labeled with the relevant batch number, formulation identification, and any special handling instructions (e.g., “store in a cool, dry place”). The labels should be clear, legible, and permanently affixed to the containers.
- If any raw material is not immediately used in the formulation process, it should be securely stored in the designated storage area. Ensure that the material is not exposed to any conditions that may affect its quality, such as temperature fluctuations, humidity, or contamination.
- Any excess material that is not used should be returned to its appropriate storage location, ensuring that it is properly labeled and stored to prevent mix-ups with other materials.
5.4 Quality Control Checks
- The QC team will periodically verify the quantities of dispensed raw materials to ensure that they match the amounts specified in the formulation recipe. This check will be done at the time of dispensing and after the formulation has been completed.
- If any discrepancies are found in the quantities dispensed, QC will investigate the cause of the deviation. Any corrective actions, such as adjusting the dispensing process or re-weighing the materials, will be documented and addressed immediately.
- In addition to verifying the quantities, QC will check the quality of the raw materials to ensure they meet the required specifications. This may include visual inspections, tests for purity, and checks for contamination.
5.5 Documentation and Record-Keeping
- All dispensing activities must be documented in the Dispensing Log, including the names of the materials, quantities dispensed, lot numbers, and any observations during the dispensing process. This log should also include the names and signatures of the personnel involved in the dispensing process.
- All raw material labels must be retained as part of the batch record for the cream formulation. This ensures traceability and provides a record of the materials used in each batch.
- The QA team will review all dispensing documentation to ensure that the process is followed correctly and that any deviations are addressed. These records will be archived for future reference and audits.
5.6 Final Review and Approval
- Once all raw materials are dispensed and documented, the batch must be reviewed by the QA team for compliance with the formulation recipe and dispensing procedure. QA will ensure that the correct materials and quantities were used and that the process was followed according to SOP guidelines.
- After the final review, the QA team will approve the batch for the next step in the manufacturing process. If any issues are identified during the review, the batch will be put on hold until corrective actions are taken.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- PO: Purchase Order
- GMP: Good Manufacturing Practices
7. Documents
- Dispensing Log (Annexure-1)
- Material Transfer Log (Annexure-2)
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 Dispensing and Weighing of Raw Materials
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Dispensing Log
| Material Name | Batch Number | Quantity Dispensed | Dispensed By | Time/Date |
|---|---|---|---|---|
| Active Ingredient X | 12345 | 500g | John Doe | 05/03/2025 |
| Excipient Y | 67890 | 300g | Jane Smith | 05/03/2025 |
Annexure-2: Material Transfer Log
| Material Name | Batch Number | Quantity Transferred | Transferred By | Transfer Time |
|---|---|---|---|---|
| Active Ingredient X | 12345 | 500g | John Doe | 05/03/2025 |
| Excipient Y | 67890 | 300g | Jane Smith | 05/03/2025 |
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 |