SOP Guide for Pharma

Creams: SOP for Yield Calculation in Cream Manufacturing – V 2.0

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Creams: SOP for Yield Calculation in Cream Manufacturing – V 2.0

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

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.

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5. Procedure

5.1 Recording Raw Material Quantities

  1. Ensure all raw materials used in the production process are accurately weighed or measured before production begins.
  2. Record the weight or volume of each ingredient used in the cream production process in the Raw Material Log (Annexure-1).
  3. 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

  1. At the end of the production process, measure and record the total volume or weight of the final cream batch produced.
  2. Ensure that the cream is cooled and homogenized before taking the final measurements to ensure accuracy.
  3. Record the final output in the Batch Production Record (Annexure-2), noting any variations from expected output.

5.3 Yield Calculation

  1. Calculate the yield using the following formula:
    • Yield (%) = (Final Product Weight / Total Raw Material Weight) × 100
  2. Ensure that the calculation is performed for each batch and verified by the QC team.
  3. 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

  1. In case of a yield deviation, investigate the possible causes such as losses during the mixing process, excessive waste, or inefficiencies in equipment.
  2. Adjust the production process or equipment settings if necessary to optimize yield for future batches.
  3. Document all corrective actions taken in the Yield Deviation Report (Annexure-4).
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5.5 Post-Calculation Review

  1. The yield calculation and any deviations should be reviewed by the QA team to ensure that they are accurate and meet production standards.
  2. All records of yield calculations, including raw material quantities, final product output, and deviations, should be maintained for audit purposes.

5.6 Documentation

  1. Document all yield calculation data in the Batch Production Record (Annexure-2) and the Raw Material Log (Annexure-1).
  2. Ensure that all deviations and corrective actions are recorded in the Yield Deviation Log (Annexure-3) and Yield Deviation Report (Annexure-4).
  3. Review and sign off on all yield-related records by the Production Supervisor and QA team.

5.7 Final Approval

  1. 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.
  2. The QA team should ensure that yield is within acceptable limits for product consistency and quality.

6. Abbreviations

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7. Documents

  1. Annexure-1: Raw Material Log
  2. Annexure-2: Batch Production Record
  3. Annexure-3: Yield Deviation Log
  4. Annexure-4: Yield Deviation Report

8. References

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
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