Line clearance is the permission taken from the authorized QA person before starting actual production (Manufacturing, Filling and Packaging). 

The line clearance includes:

Manufacturing Area

Filling Area

Dispensing or packaging Area

Purpose and Importance

In line clearance the procedures have been established to prevent mix – up of containers, products, labels and mistakes in documents. MIx up and mistakes occurs when GMP are not followed.

Particular take should be taken:

When starting a new operation

At change of shift

When additional components are needed

After maintenance part way through the process.

Manufacturing Area

During Line clearance all equipments and area should be clean. 

Checking of all raw meterials are properly weighed or not.

The Batch manufacturing record entries are done properly or not is checked

Mixing time, granulation time , compression time etc., are checked in BMR record.

The cleaned labels of equipment should be attached in BMR

The cleaned label is attached for all the equipments which are used in production.

Filling Area

In line clearance empty bottle inspection is carried out. Wash water sample is checked. 

Clarity and pH

Filled volume

Status label

To verify whether the previous product packaging material are removed or not.

“Under use” label should be there on each equipment.