Basic Learning for the beginner

1. 1
LINE
CLEARANCE
Presented By:
Md. Mosaruf Hossan
Deputy Production Manager

2. DEFINITION :
2
Line clearance is a structured procedure for ensuring that the equipment
and work area are free of products, documents and materials from the
previous process that are not required for the next scheduled process, and
that the equipment is clean and ready for the next scheduled process.
Type A:
Applicable for Product to Product change over.
Type B:
Applicable for Batch to Batch change over of
the same product/if no activity is present..
Type C:
Shift end cleaning./
Applicable for the processing rooms which are
not used during the day otherwise the same
batch is going on for the next day.

3. 3
To avoid mix up & Cross contamination from one
product to other or from one batch to other batch.
Purpose :

4. CONTAMINATION,
CROSS-CONTAMINATION,
MIX-UP
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5. MAIN SOURCE :
5

6. MITIGATION :
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7. MIX-UP
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A Mix–Up may be defined as:
-An unplanned combination of various compounds.
-A mistake brought about wrongly identifying one
material for another.
A mix-up can be caused by bad judgment or lack
of attention to detail, i.e., human error.
It can also occur through poor communication
between personnel.

8. CAUSES OF MIX-UP :
8
-The close proximity or location of similar items
( e.g. Atasin 40 Tablet & Atasin 80 Tablet Foil,S-1 )
- Items having the same colour or combination of
colours ( e.g. White & Off-White )
- Multiple products handled at the same
time/packaging
- Use of the same apparatus or equipment for
multiple products
- Improper storage of sterile and non-sterile
products
- Care not being taken during packaging and/or
repackaging of products
- Mistakes made when dispensing
- No proper line clearance procedure
- Unused labels or earlier production left in the
production area
- Improper documentation and labeling

9. 9
- No ID code on materials or
products
- Inadequate training of personnel
- Failure of the processing equipment
- Manual packaging and repacking
- Inadequate control or procedures
- Rejection of handling
- Improper affixing of labels
- Reprocessing
CAUSES OF MIX-UP : -Vendor’s Location, for example the
printer may be located some distance
from the PC or device that sends the
output to the printer. The wrong
person may mistakenly use the wrong
printout e.g., for labels.
- Improper or lack of proper
communication
- Same personnel handling two
machines or equipment at the same
time
- Lack of proper validation

10. 10
Learning Points:
Importance of Line
clearance
Separation of different line
Before Manufacturing
Preparation of
Manufacturing
Before Packaging
Preparation of Packaging

11. 11
Importance of Line Clearance
 All manufacturing machines, containers and areas should be properly
cleaned and checked to prevent cross contamination or particulate
contamination of products.
All packaging and labeling components must be removed from
machines as soon as a run has been completed to prevent components
just used from mixing in with the components for the next run.

12. LINE CLEARANCE
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Line clearance is the permission taken from the authorized QA person before starting
actual production (Manufacturing, Filling and Packaging).
The term line clearance is used for the documented act of conducting any
necessary removal of products and materials from a manufacturing line to prepare
the line for the next production(packaging).
A line clearance procedure is having three stages:
1.Clearing:-Remove the previous product related items from the area/line i.e. pre
printed ampoules , plugs , left over solution/material , product , labels , printed
cartons.
2.Cleaning:-Cleaning to be carried out only after clearing of previous products.
Clean the as per current SOP.
3.Checking:-Checking to be carried out only after clearing and cleaning of
previous products.

13. 13
Separation of different line
cGMP regulation requires that Packaging line and Manufacturing line
and each packaging line and each manufacturing line must be kept
separate from each other by appropriate space and partitions
Manufacturing
Lines
Packaging
Lines
Each Packaging
Lines
Each Packaging
Lines

14. 14
Before Starting Manufacturing
Prior to start the production operation, determine the
suitability of the gowning, environmental controls,
processing line, equipment, and materials.
Line clearance approval should be taken from both
Production & QA Department.

15. 15
Before Starting Manufacturing
Prepare the production area by completing the following tasks:
Clearing :
remove all documentation, materials, and equipment
from the previous production operation.
Cleaning :
clean the line and associated equipment according to
established procedures :
Checking :
Complete all appropriate entries into logs for equipment
maintenance and calibration
Place only documentation, materials, and equipment
designated for the scheduled production operation in the
area.
Verify environmental controls are operational and within
established limits

16. 16
Before Starting Manufacturing
 Notify Quality Assurance and request a line clearance check
for the area.
 Obtain a Line Clearance Checklist. and complete the top
section for operation name, date, part number, and lot
number.
 At the completion of the inspection, sign and date the form.
Attach the form to the history record for the production lot.

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Preparation of equipment before any
manufacturing begins
All equipment and utensils must be properly maintained,
cleaned and record must be kept.
All major manufacturing equipment, storage containers
and processing lines must be marked with the product
name and lot number.
All major equipment must have their identification
number recorded in the Batch Production Record

18. 18
cGMP Regulation
 The product must be manufactured as stated in the Batch
Production Record and according to SOP’s.
 At the completion of each manufacturing step, the Batch
Production Record must be signed in the appropriate space by
the person performing the job immediately after it is done.
 During manufacturing In-process testing is done by Production and
Quality Assurance.
 At any point, adjustments to bring the batch up to specifications may be
made according to the SOP’s
 Adjustment must be properly recorded in the batch production record.

19. 19
We comply with cGMP regulations by
Carefully following the SOP’s
Properly completing all production forms
Making proper entries in each equipment log
book

20. 20
Preparation of Packaging
STEP 1
• Packaging lines and machines must be cleaned
and inspected.
STEP 2
• Packaging lines must be identified with proper
identifying lot number.
STEP 3
• Quality Assurance and Packaging Departments
give approval

21. 21
Preparation of Packaging
The packaging department follows the packaging directions for each
individual lot.
This includes affixing the lot number and expiration date
All lebeling and packaging materials go to a receiving area for inspection,
sampling and testing or examination by Quality Control to ensure that they
meet company standards.
Labels are in different sizes depending on their
– packages
– dosage forms and
– Strengths
All the labels for one product must be stored together with each type and size
label in its own compartment.
All label must be stored under lock and key. (in a limited access area.)
The use of on-line label printing equipment must be carefully controlled.

22. 22
cGMP Regulation
 Every label must be accounted for with entries made in the
appropriate records.
 All packaging and labeling components must be removed from
machines as soon as a run has been completed to prevent
components just used from mixing in with the components for the
next run.
 Labeled and Packaged product must be examined during the packaging
operations to make sure that containers and cartons in each lot are correctly
labeled and packaged.
 Unused coded labels must be destroyed.
 Destroyed labels must be accounted with sign & date.

23. QUOTES :
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THANK YOU