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.

2. RESPONSIBILITY
QA Manager
Production Manager

3. PROCEDURE :

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.