Assigning Mfg, Exp Dates to batches SOP

In this post we come to know how Assigning Mfg, Exp Dates to batches SOP in a pharmaceuticals company.

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Objective:

To lay down the procedure for assigning manufacturing/expiry dates to bathes.

Scope:

The scope of this SOP applies to the procedure for assigning manufacturing/expiry dates to batches.

Responsibility:

It is the responsibility of all Production Pharmacists to ensure that this SOP is followed as it is written.

It is the responsibility of Production Manager to ensure that this SOP is followed in its entirety, reviewed and update as necessary.

DEFINITIONS & ABBREVIATIONS

SOP: Standard Operating Procedure

Procedure:

The 1st processing date of batch is considered as manufacturing date of the particular batch.

In case the process carried out on last days of the month, the date of next month is assigned as manufacturing date to the batch.

Expiry dates are assigned in accordance with the currently prescribed price list.

Expiry dates is considered as same as provided by supplier for ready to use manufacturing products.


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