sop of Deviation in batch size


sop of Deviation in batch size


1. OBJECTIVE : To issue a procedure for deviation of batch size from master formula required to match demand and  supply.

QA Manager
Production Manager


a. Divide the order quantity in standard batch size and produce as many full batch possible out of that.

b. The remaining quantities should should not be less than 50% of the standard batch size.

c. Incase the remaining quantity is less than 50%, readjust the previous batches to render

them in stipulated limits (i.e. more than 50% of the batch size.)

d. If smaller batches (less than 50%) are to be taken ;equipment & container sizes are altered accordingly.

4. Ref. Doc :
a. SOP for manufacturing of the respective dosage form.

b. Master formula of that product.

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