What is Line Clearance in Pharmaceutical Industries?


Line clearance is a crucial process in the pharmaceutical industry that ensures the safety and quality of products being manufactured. It involves a thorough inspection and verification of equipment, facilities, and materials before starting a new batch production or after completing a batch.

The line clearance procedure typically consists of three parts
Clearing
The physical removal of any materials from the previous process that are not necessary for the next process

Cleaning
The disinfection and drying of all surfaces and equipment

Checking
A supervisor or quality manager inspects the line thoroughly before the next scheduled process can begin.

The main goal of line clearance is to prevent cross-contamination and ensure that all previous product residues, debris, and documentation have been removed before a new production batch begins.

This process safeguards product integrity and aligns with Good Manufacturing Practices (GMP).

The line clearance procedure should ensure that all materials, products, labels, and records from previous operations have been removed.

The person responsible should initial the batch record to show that a clearance check has been carried out. The line should also be clearly labeled to show the product and its strength to be packaged.

Importance of Line clearance
▪️Prevents chances of mix up.
▪️Assures the quality of the product.
▪️Assures cleaning of the area and equipment.

Quality assurance officer checks following
▪️Cleaning of doors, walls and ceiling.
▪️Cleaning of windows and HVAC ducts etc
▪️Checking of equipment.
▪️Surface below the equipment should be checked for the previous product leftovers.
▪️Calibration status of weighing balance.
▪️Temperature and humidity of the area.
▪️Differential pressure of the area.
After ensuring all the requirements of the area and equipment the product to be processed is checked.

Following general parameters are checked
▪️Batch number of the product.
▪️Lot number of the product.
▪️Quantity or weight of the ingredients or components.

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