Line clearance is a critical process for pharmaceutical companies to ensure the safety and quality of their products. It involves a thorough inspection of equipment, materials, and the manufacturing area to remove any traces of the previous product or process. This helps prevent cross-contamination and ensures that the next product manufactured on the same line meets the required quality standards. Line clearance is an essential part of Good Manufacturing Practices (GMP) and is a regulatory requirement in the pharmaceutical industry. Proper implementation of line clearance procedures can help companies minimize the risk of product recalls, ensure compliance with regulatory requirements, and safeguard the health and safety of patients.

1. Line Clearance
Line clearance is the activity or process which ensures that the area, line, or equipment
is free from residues, and labels of previous products and is ready for dispensing,
manufacturing, printing or packaging activity.
We Check During Line Clearance
During line clearance, QA officers check that all the area and equipment are properly
cleaned/washed and there is no leftover of the previous product.
The following main points are checked,
• Area/equipment Identification
• Calibration Record
• Temperature
• Humidity
• Differential Pressure
• Log Books Record
Line Clearance In Pharmaceutical Industries
Line clearance is a critical process which is performed in pharmaceutical industries before start-up of
Dispensing process, manufacturing process or Packaging process.
Definition Of Line Clearance
Line clearance is defined as,
The process which assures that all the leftovers of the previous product are properly cleaned before the
start-up of the next process.
Explanation of line clearance
The concept of line clearance in pharmaceutical industries is established to prevent mix-ups and to
enhance product quality. As the name indicates Line Clearance have two components,
Line
Clearance
Line
A line may be any room, area or a place in a pharmaceutical industry where dispensing, manufacturing
or packaging activity is performed.
All the equipment or components which are online or in-line are checked critically during line clearance.

2. Clearance
We use the word “To Take Line Clearance” in pharmaceutical industries. Mean clearance is a sort of
certificate for line, which is provided by the Production officer and then by the QA officer to state that
line is ready for performing activity. Clearance approval allows the operators to start the activity in
respected area. Before taking the clearance certificate of the line, the line is Cleared, cleaned or washed
depending on the requirements.
3 C of Line Clearance
For general understanding, line clearance has 3 C which are given as follow,
Clearing Of Line
Cleaning Of Line
Checking Of Line
Clearing Of Line
The clearing is the first C of the line clearance and it consists of clearing of the line. In this stage, all the
previous product leftovers e.g. labels, polythene bags, unit cartons etc. are removed from the line.
Cleaning of Line
Clearing of the line is 2nd
C of the line clearance. After completion of one operation and before the start
of the next operation, first we clear the line and then the cleaning of the line is performed.
All the equipment or components which are online or inline are cleaned properly.
Cleaning is usually of three types which are given as follow,
Type A Cleaning
Type B Cleaning
Type C Cleaning

3. Type A Cleaning
Type A cleaning is also known as minor cleaning or batch to batch cleaning and it is a short cleaning
activity. In type A cleaning, washing of equipment or area is not required, just the area is cleared and
equipment are cleaned from outside with lint-free cloth. Type A cleaning is performed during the
following cases,
Between Batches of Same product
Same product but strength is changed in Ascending order mean from lower strength to higher strength.
Minor Preventive maintenance in which parts which are in direct contact with the product are not
exposed.
Type B Cleaning
Type B cleaning is also known as major cleaning. It is a long activity and all the equipment and area is
washed during Type B cleaning. All the equipment are washed with food-grade detergent and rinsed
with purified water. Then all the equipment are dry with a lint free cloth and are disinfected with 70%
IPA.
Type B cleaning is performed during following cases,
During product change over.
During Same product but strength is changed in descending order mean from higher potency to lower
potency.
Same product but color is changed.
Same product but the flavor is changed.
Major preventive Maintenance.
When area is used after expiration of cleaning validation time of equipment.
Type C Cleaning
Type C cleaning is the general cleaning which is performed at the end of the shift and where the work is
to be started again on the next day. In this type of cleaning all the materials from line are properly
closed or stored in containers or polythene bags. Any component or material is not left exposed.

4. Checking Of Line
Checking of the line is 3rd
C of line clearance. After clearing and cleaning, checking of the line is done.
The area supervisor checks the line thoroughly for any deficiencies then he calls the Production Officer
and the production officer checks the parameters of the line to be cleared. He checks the area,
equipment and then the product which is to be started or processed.
Importance of Line clearance
Prevents chances of mix up.
Assures the quality of the product.
Assures cleaning of the area and equipment.
Critical Note for Packaging Lines.
It is commonly observed that three, four or more packaging lines are installed in a packaging hall, in
pharmaceutical industries.
In some pharmaceutical industries, these packaging lines are separated by partitions or color markings
on the floor but in some pharmaceutical industries no partition or marking lines are available which
increases the chances of mix up.
If Partitions are installed between lines, these partitions should be at such a height that nobody can
throw any component of packaging material over the partition from one line to the other line.