product batches manufactured at the facility, including vials, ampoules, and prefilled syringes, from solution preparation to final yield reconciliation.

3. Responsibilities

• Production Executive: Records real-time yield data and identifies deviations.
• Quality Assurance (QA): Reviews and approves yield records and investigates deviations.
• Manufacturing Supervisor: Oversees yield performance and signs off final batch reconciliation.

4. Accountability

The Head of Manufacturing is accountable for ensuring implementation and compliance with yield monitoring procedures.

5. Procedure

5.1 Yield Types and Definitions

• Theoretical Yield: The expected quantity of product based on input raw materials.
• Actual Yield: The measured output after manufacturing.
• Percentage Yield: (Actual Yield / Theoretical Yield) × 100

5.2 Monitoring at Each Manufacturing Stage

1. Solution Preparation:
   • Record volume of prepared solution.
   • Note all losses due to sampling, testing, or equipment retention.
2. Filtration:
   • Record volume before and after filtration.
   • Account for losses due to filter hold-up volume.
3. Filling:
   • Record quantity of filled units.
   • Note volume per unit, overfills, and underfills.
   • Calculate yield after filling.

5.3 Yield Calculation Steps

1. Calculate theoretical yield based on the batch size (e.g., 100 L = 100,000 mL = 100,000 ampoules @ 1 mL).
2. Record actual quantity obtained after filling and sealing.
3. Calculate % yield:

   % Yield = (Actual Units / Theoretical Units) × 100

5.4 Documentation and Review

1. Enter details in the Batch Yield Logbook (Annexure-1).
2. Attach filled yield calculation sheet to the Batch Manufacturing Record (BMR).
3. QA to review yield and approve or initiate deviation if outside limits.

5.5 Yield Deviation Investigation

1. If yield is <95% or >105%, treat it as a deviation.
2. Production must fill a Deviation Report (Annexure-2).
3. QA to conduct a root cause investigation and implement CAPA if necessary.

5.6 Corrective and Preventive Actions

• Corrective action may involve process modification or retraining.
• Preventive action may include additional checks at filtration or filling.

5.7 Yield Trending

1. QA to maintain monthly yield trend charts by product type.
2. Report consistent losses for further process optimization.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• BMR: Batch Manufacturing Record

7. Documents

1. Batch Yield Logbook – Annexure-1
2. Deviation Report – Annexure-2
3. Yield Calculation Sheet – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO GMP Guidelines – Manufacturing Controls
• 21 CFR Part 211 – Subpart F – Production and Process Controls

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Batch Yield Logbook

Date	Batch No.	Theoretical Yield	Actual Yield	% Yield	Remarks
21/06/2025	INJ/2025/045	100,000	98,500	98.5%	Within Limit

Annexure-2: Deviation Report

Report No.	DEV/135/2025/01
Date	22/06/2025
Batch No.	INJ/2025/048
Observed Yield	92.8%
Investigation Summary	Spillage observed during filling
Corrective Action	Operator retraining
Preventive Action	Additional filling line supervision

Annexure-3: Yield Calculation Sheet

Batch No.	INJ/2025/045
Total Volume Prepared	100 L
Volume per Unit	1 mL
Theoretical Units	100,000
Actual Units	98,500
% Yield	98.5%

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial release	New SOP	QA Head
24/06/2025	2.0	Expanded to include trends and deviation reporting	Annual Review	QA Head