13.

BATCH RECONCILLATION SHEET

S. No. Details Quantity

A. Standard Batch Size 200,000

B. Recoverable Rejection Added from Batch No.:

C. Total Batch size for Reconciliation (A+B)

D. Total Quantity Transferred to FINISHED GOODS STORE

E. Physician’s Sample

F. Control Sample/Stability Study Sample

G. Samples drawn for In-process and F/P Analysis

H. Recoverable Rejection

I. Total Yield (D+E+F+G+H)

J. % of Yield (I X100/C)

 Lower Limit 97 % of the Theoretical Yield.

 If the actual yield is beyond the above limit, a “Failure Investigation” is to be carried out
and explanation must be given below.

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Manufacturing Pharmacist Production Manager QA Manager