LINE CLEARENCE  

Relevance & Its effective,

implementation

By

Ravi Srivastava
MR
WHAT IS LINE CLEARANCE ?

 LineClearance is a procedure to prevent mix

up of product/material, containers, labels and
mistakes during on going activities to ensure
intended safe product
WHY LINE CLEARANCE?

•Itensures suitability of area for the

work/activity.
• It prevents inadvertent lapses.

• Keeps area regularly clean and organized.

• Creates confidence among workers and

organization
WHO IS RESPONSIBLE?

• Supervisor /section in charge is responsible

for maintaining line clearance of the area

• QA inspector is responsible for verifying and

approving the area for work/activity
IS IT REGULATORY OR STATUTORY?

• Prevention of cross contamination/mix up is

defined in schedule T GMP as regulatory
requirement.

• It is basic requirement of all the applicable

guidelines specially w.r.t food safety.
DRUG AND COSMETIC ACT 1940 SCH T GMP

 The manufacturing area shall provide adequate

space(Manufacture & Quality control) for orderly
placement of equipment and material used in any
of the operations for which these are employed so
as to facilitate easy and safe working and to
minimize or to eliminate any risk of mix-up
between different lines, raw material and to
prevent the possibility of cross contamination of
one drug by another drug that is manufactured,
stored or handled in the same premises.
LINE CLEARANCE AS PER US FDA
 Line Clearance:- Segregation and cleaning of
different processing and work areas to avoid
cross contamination.

(21 CFR Part 212 – Chap

823)
HOW IT CAN BE ACHIEVED?

 It can be achieved by strict implementation of

three actions before start of work i.e.

• Clearing
• Cleaning
• Checking
CLEARING:-  
 Remove the previous product related items
from the area/line i.e. pre printed materials,
left over solution/material , product , labels ,
printed cartons , batch coding , packed
products , documents.
CLEANING:
 Cleaning to be carried out only after clearing
of previous products.
 Clean area as per current SOP.

 Clean the equipment as per current SOP and

send the rinse water / swap to Q.C for
analysis where required i.e. product change
over. .
CHECKING:
 Checking to be carried out only after clearing
and cleaning of previous products.
 Area/line in-charge ensure the clearing and
cleaning. Then Q.A has to cross check the
area/line. The same should be recorded in the
BMR.
 Area/line clearance failure should be recorded
in deviation format and Investigation to be
carried out.
CHECKING:
 LINE CLEARANCE PROCEDURE IS
APPLICABLE FOR THE FOLLOWING
STAGES:
1) Dispensing

2) De-cartoning

3) Washing and sterilization

4) Manufacturing and filtration

5) Filling /Packaging

6) Leak test

7) Batch coding
AREA/LINE CLEARANCE FAILURE:-
 Area/lineclearance failure:- Any item , which could
compromise quality , found during checking / in a
subsequent batch is classified as a line clearance
failure. The same to be informed to Q.A manager
and stop the line until reasons are found and
necessary action taken to avoid any mix-ups.

 Criticalline clearance failures must be subjected to

deviation report and to be investigated to identify
the root cause.
CONTROL OF REJECTION:-
 Rejected item should be kept in separate
container with lid.
 Rejected status label (red color) should be
described with details.
 Online rejected items should be kept in closed
container with status label.
LINE CLEARANCE - IMPLEMENTATION
 Line clearance to be carried out prior to
commencement of same product different batch
or different product.
 Check the effectiveness of line clearance after
the restart of the operation after the break.
 Checking of any area line must not commence
until all clearing and cleaning activities are
complete and signed off.
 If the line is not used immediately after
cleaning and clearing it must be rechecked
immediately before start..
LINE CLEARANCE –IMPLEMENTATION
CONTD…
 Trails , maintenance work and other activity
which could hamper the clear and clear status of
an line / area.
 The person responsible for line clearance must be
informed of all such occurrences and before the
area / line is cleared as suitable for production.
 After obtaining line clearance a status board of
the activity in progress to be displayed or
recorded and signed off.
LINE CLEARANCE – IMPLEMENTATION
CONTD..
 The design of equipment and process areas
shall be considered with respect to impact upon
line clearance efficiency.
 Equipment design shall be assessed for
potential rouge traps and these shall be
designed out or minimized.
 Equipment shall be designed such that it is easy
to dissemble and reassemble. Clear guards
shall be used where possible to aid visibility.
LINE CLEARANCE –IMPLEMENTATION
CONTD..
 The use of torches or flash lights , mirror can
be useful to make all areas of the area /
equipment as visible as possible.
 The process area shall have no excess
furniture.
Ex:- Benches , storage
Proposed Checks or as defined By QA Person after
intimation from area/section in-charge/supervisor for
approval
The area must be clean.
There must not be any traces of previous stage material.
There must not be any spillages of cleaning washes.
There must not be any observed dust.
There must not be excess tools / equipment as they can affect smooth
functioning.
 Inspect the equipment for cleanliness & absence of previous product .
 Check the status label of equipment.
 Check the cleaning procedure and cleaning record.
 Check the Environmental parameters like pressure differential, relative
humidity, temperature etc are in limit and recorded .
 Inform to Engineering /concerned dept. if any discrepancy is observed.
 Check the equipment logbook.
 Based on above observations QA will sign on document and approved
for work/activity status label for
GENERAL CHECKS BY Q.A. INSPECTOR
After receiving intimation for line clearance from
Production, Q.A inspector visit the concerned
department.
Check that work station is clean of previous product
and spillage on the line area is suitably mopped and
cleaned & if required sanitized adequately.
Check name of product ,batch no, batch size,
manufacturing and expiry date.
Check that all relevant documents are complete in file.
Check status of product approved or not approved.
Issue line clearance after confirmation that all the
requirements of check list of the relative process have
been fulfilled.
SPECIFIC CHECKS - PACKING
Specific checks are design and defined w.r.t specific work area/activity.
 Check temperature & RH if applicable.
 Check all the packaging material identities of the product according to
product specification.
 Check that all the relevant record is complete.
 Check that all the materials are released for packaging are approved.
 Check the batch no, manufacturing and expiry date of product to be
packaged and that printed on packaging material.
 Confirm the price in case of commercial packaging if mentioned.
Issue line clearance certificate and check list for packaging after
confirmation that all the requirements of packaging check list have been
fulfilled.
 Check the compliance of line clearance at regular intervals of time.
 Check the material and received from store and verify against packing
in order.
OPTIMIZATION OF LINE CLEARANCE
 Defining line and layout.
 Defining and managing the process

 Equipment Modification

 People element

 Training for writing/recording deviation or

process etc.
 Hotspots

 Classification of Line clearance deviation.

LIVE LINE CLEARANCE:-
 “Live line clearance” has been successfully used
as a useful training tool for new operators or for
the introduction of new equipment. It involves the
placing of “dummy” articles with in the area /
line after the checking is completed.
 Operators are then asked to find the dummies. If
all of the dummies are not found then this may
indicate the need for further operator training or
modification to the procedures or checklist.
LIVE LINE CLEARANCE:-
 The dummies should be placed in areas where
clearing or checking are known to be a
problem.
 If “Live line clearance” is to be used then it is
essential that strict , proceduralised control is
in place.
 The dummies used should not be capable of
being confused for the genuine article. Defaced
genuine articles should not be used as
dummies.
LIVE LINE CLEARANCE:-
 Dummies used should not be capable of being
packaged or further processed. An example of
an acceptable dummy is a colored plastic ,
magnet, etc.
 Strict , proceduralised reconciliation should be
done of the dummies and all dummies should
be accounted for before production may
resume.
LIVE LINE CLEARANCE:-
 Q.A personnel shall be given training for line
clearance activity and evaluated for the
effectiveness.
 Also frequently or at least twice in a year all
Q.A personnel in process department will be
evaluated for line clearance activity
effectiveness.
POTENTIAL CAUSE OF IMPROPER LINE
CLEARANCE
 Inadequate space
 Inadequate infrastructure

 Inadequate procedure

 Inadequate awareness among workers

 Inadequate awareness among QA inspector

 Non availability of QA inspector

 INTERACTIVE SESSION
 Status of line clearance in your Department
/section /area.
 Identify gaps w.r.t to line clearance in your
area.
 Suggest how to eliminate these gaps.
 THANKS
FOR YOUR ACTIVE
PARTICIPATION

JAI GURU DEV