Standard Operating Procedure for Yield Calculation in Cream Manufacturing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/080/2025 |
| Supersedes | SOP/CRM/080/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
This SOP describes the procedure for calculating the yield of cream batches produced in the manufacturing process. The objective is to ensure that the yield is consistent, accurate, and in line with expected production outputs.
2. Scope
This SOP applies to all cream batches produced in the Creams Department. It covers the process of calculating yield, from the raw material inputs to the final cream product output.
3. Responsibilities
- Production Team: Responsible for recording the raw material quantities and final output during the production process for yield calculation.
- Quality Control (QC): Ensures the accuracy of the yield calculations by verifying the raw material amounts and the final product volume or weight.
- Quality Assurance (QA): Ensures compliance with GMP and verifies the accuracy of yield calculations against production standards.
4. Accountability
The Head of Production is accountable for ensuring that yield calculations are performed and documented accurately. The QA Manager is responsible for reviewing and approving yield calculations to ensure they meet quality and regulatory standards.
5. Procedure
5.1 Recording Raw Material Quantities
- Ensure all raw materials used in the production process are accurately weighed or measured before production begins.
- Record the weight or volume of each ingredient used in the cream production process in the Raw Material Log (Annexure-1).
- Ensure that all material quantities are verified by the Production Supervisor to prevent any discrepancies in the raw material inputs.
5.2 Recording Final Product Output
- At the end of the production process, measure and record the total volume or weight of the final cream batch produced.
- Ensure that the cream is cooled and homogenized before taking the final measurements to ensure accuracy.
- Record the final output in the Batch Production Record (Annexure-2), noting any variations from expected output.
5.3 Yield Calculation
- Calculate the yield using the following formula:
- Yield (%) = (Final Product Weight / Total Raw Material Weight) × 100
- Ensure that the calculation is performed for each batch and verified by the QC team.
- If the yield deviates from the expected range, document the reason for the deviation in the Yield Deviation Log (Annexure-3).
5.4 Analyzing Yield Deviation
- In case of a yield deviation, investigate the possible causes such as losses during the mixing process, excessive waste, or inefficiencies in equipment.
- Adjust the production process or equipment settings if necessary to optimize yield for future batches.
- Document all corrective actions taken in the Yield Deviation Report (Annexure-4).
5.5 Post-Calculation Review
- The yield calculation and any deviations should be reviewed by the QA team to ensure that they are accurate and meet production standards.
- All records of yield calculations, including raw material quantities, final product output, and deviations, should be maintained for audit purposes.
5.6 Documentation
- Document all yield calculation data in the Batch Production Record (Annexure-2) and the Raw Material Log (Annexure-1).
- Ensure that all deviations and corrective actions are recorded in the Yield Deviation Log (Annexure-3) and Yield Deviation Report (Annexure-4).
- Review and sign off on all yield-related records by the Production Supervisor and QA team.
5.7 Final Approval
- The QA team must review all yield records and approve them before the batch is considered final. This includes verifying that yield calculations are correct and that any deviations are adequately addressed.
- The QA team should ensure that yield is within acceptable limits for product consistency and quality.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Raw Material Log
- Annexure-2: Batch Production Record
- Annexure-3: Yield Deviation Log
- Annexure-4: Yield Deviation Report
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- FDA Guidelines for Cosmetics Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Raw Material Log
| Batch Number | Raw Material | Quantity Used | Weight/Volume | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | Water | 500 L | 500 kg | John Doe | No issues |
Annexure-2: Batch Production Record
| Batch Number | Production Date | Quantity Produced | Operator | Comments |
|---|---|---|---|---|
| 98765 | 21/01/2026 | 200 L | Jane Smith | No issues |
Annexure-3: Yield Deviation Log
| Batch Number | Deviation Percentage | Cause of Deviation | Corrective Action | Operator |
|---|---|---|---|---|
| 98765 | 5% | Excessive waste | Revised mixing time | Jane Smith |
Annexure-4: Yield Deviation Report
| Batch Number | Deviation Type | Analysis Result | Corrective Measures | Approval |
|---|---|---|---|---|
| 98765 | Under Yield | Due to over mixing | Adjusted mixing speed | QA Head |
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 |