SOP for Handling of Yield Non-conformance
Objective : To lay down a procedure for handling of yield non-conformances.
Scope : This standard operating procedure is applicable for formulation plant. This SOP is applicable for those batches in which the yield obtained is less/more than the expected yield.
Responsibility : Supervisor / Manager-Production shall be responsible for reporting & investigation of such discrepancies.
Head production shall be responsible for implementation of this SOP.
Head QA/ Designee shall be responsible for the compliance of this SOP.
Abbreviations and Definitions
Yield : The quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product. (Generally, expressed as percentage).
Yield Non-conformance: Yield obtained is less/more than the expected yield (Theoretical yield) as mentioned in BMR.
Expected Yield: Theoretical yield means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production as mentioned in BMR (Theoretical yield). The limit of expected yield shall be based on the outcomes/findings of technology transfer/optimization/validation batches.
Percentage of Theoretical yield: The ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage
Yield obtained: Actual yield obtained after a manufacturing step/stage/process.
Procedure :
If the product yield obtained, does not comply the standard limits mentioned as Expected Yield in the BMR, then the following steps shall be followed:
Production shall fill “Yield Non-conformance Evaluation Form”.
Discrepancy in yield shall be investigated and the need for CAPA shall be assessed as per SOP. During the investigation batches preceding the batch in question shall be checked for the same parameter.
Production personnel filling the “Yield Non-conformance Evaluation Form” shall investigate for low/high yield and fill investigation details in the form. The same aspect shall also be taken care for batch (es) to be manufactured.
This form shall be duly signed by Production Personnel.
The investigation shall be verified by Officer IPQA.
The form shall then be approved by Head Production.
After approval of form from Head production, it shall be submitted to QA.
QA shall assign number to Yeld Non-conformance. It shall be nine digit numbers:
First three shall be “YNC” denoting Yield Non-conformance.
Fourth, fifth and sixth shall be serial number.
Seventh shall be “/”.
Eighth and ninth shall be financial year.
Example: First Yield Non-conformance in the financial year 2025-20026 shall be YNC001/25.
QA shall then give disposition, duly authorized by Head QA.
After approval, the original form shall be retained by QA for records and a copy of this shall be attached in BMR.
The original form shall be retained by QA till the destruction of BMR of the batch in question.
For investigation of Yield Non-Conformance refer YNCR checklist.