Pharmaceutical Status Labeling – A Brief information


What is Status Labeling?

Status labeling is a “labeling procedure, informed the status, when pasted on anything, it can be a product, equipment, area etc. whatever is lying under premises”.

It is practice as per GMP to aware all personnel with the current status of the same on which it has been displayed.

Why status Labeling required?

As per GMP guidelines everything which is lying in pharmaceutical premises should have their status as precautionary to prevent mix ups, incidents and to keep awareness.

Issuance, Control & Inventory of status Labeling

Pharmaceutical premises should have all stages status label pre-printed or can be computer printing. But as per usage of huge preprinted can be ease the work.

To keep the proper management of status labeling, an SOP should be available in quality Assurance department and it should be distributed to all.

All status labels should be the part of this SOP as annexure, and each status label should have format no.

When a label has format no. it should be controlled by QA. Issuance of labels should be done by counting to the related departments, after getting requisition from them; status label controlling should be done by its reconciliation.

Reconciliation is possible when a perfect inventory implemented, inventory should controlled by QA.

All issued status label will be the part of batch records.

Status label have only important and relevant information about the status, lengthy information is not required.


A pharmaceutical product should be its original form and its quality should be maintained until it reaches the end users.

As per GMP, A Product, Area and Equipment should tell their status itself if having a well designed and informative status label.

E.G. has to be seen on other article of status labeling like:

SOP on Status Labelling & its Control 

Status Label and Labelling Requirments in Pharmaceuticals 


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