CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 1 of 10
1. OBJECTIVE
1.1 To provide a procedure for the line clearance in dispensing, manufacturing and packaging
area.
2. SCOPE
2.1 This procedure is applicable to the warehouse and production department where line
clearance is required prior to start of any product batch at dispensing, manufacturing and
packaging operation.
3. RESPONSIBILITY
3.1 Follow up : QA Officer/Executive
3.2 Responsibility : Production, warehouse and QA for compliance of this SOP.
3.3 Over all responsibility: IPQA In-charge
4. PROCEDURE
Ensure the following activity before giving and taking the line clearance for respective batch
product/process.
4.1 Warehouse, Dispensing of Raw Material:
After getting intimation from the store personnel for line clearance inspect the area for the
following things:
4.1.1 Inspect general cleanliness of the dispensing area, airlock and wash area. The area
should be clean.
4.1.2 The dispensing area should be free from any previously dispensed materials,
previous product material or any kind of objectionable items / materials like bags,
traces of loose powder of the previous product materials, dust or any other foreign
particle.
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 2 of 10
4.1.3 Ensure that the cleaning & sanitization of the area is recorded in the respective log
book.
4.1.4 The dispensing area should be free from excess tools / equipment/unwanted material.
4.1.5 Inspect the tools / containers / equipment for cleanliness and absence of previous
product material. Check the status label on tools / containers / equipment.
4.1.6 Ensure that the all-electronic weighing balances and other measuring devices used
for the process are cleaned and calibrated.
4.1.7 Ensure that the all equipment and instruments used for the process are within its due
date of Preventive maintenance.
4.1.8 Ensure that the calibration of balances and other measuring devices are recorded in
the respective log books.
4.1.9 Check the temperature & % relative humidity of the dispensing area. It should be
within the limit as mentioned in the respective BMR.
4.1.10 Check the cleanliness and effective functioning of the Reverse Laminar Air Flow
with prefilters & check the differential pressure. The differential pressure should be
within the limit as mentioned in the respective BMR and SOP.
4.1.11 In case of product change over check & ensure that the return air riser filters are
cleaned. Ensure that the cleaning of return air riser filters is recorded.
4.1.12 Ensure availability of all the materials to be used for dispensing e.g. Spoon, Scoops,
poly bags, approved raw materials.
4.1.13 Ensure material name, material code, A R no. , use before date and assay in case of
API on the approved label prior to dispensing of the material.
4.1.14 Check the BOM and calculations for raw materials is correct and ensure that the
batch record should be filled up to the previous stage.
4.2 After compliance of all the check points, certify area clearance by signing in appropriate place
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 3 of 10
provided in BMR.
4.3 In case any deficiency related to any of the activity is found, do not clear the line for next
processing and inform the Stores Officer, executive, designee for remedial action.
4.4 Stores designee should rectify the deficiency and request again to QA Officer for inspection
4.5 Re-inspect for the deficiency noticed originally, if found satisfactory, clear the line for
processing.
4.6 If the deficiency is not yet rectified, do not clear the line and ensure that next processing will
not start without QA line clearance.
4.7 Repeat the same as mentioned in above till deficiency is rectified.
4.8 Warehouse, Dispensing of Packaging Material:
After getting intimation from the store personnel for line clearance inspect the area for the
following things.
4.8.1 Inspect general cleanliness of the dispensing area, The area should be clean.
4.8.2 The dispensing area should be free from any previously dispensed materials,
previous product material.
4.8.3 Ensure that the all-electronic weighing balances and other counting devices used for
the process are cleaned, calibrated and record of the same should be available.
4.8.4 Ensure availability of all the packaging materials as per the BOM.
4.8.5 Ensure material name, material code, A R no. , Artwork no. on the approved label
prior to dispensing of the material.
4.8.6 Check the related documents and ensure BPR should be filled up to the previous
stage.
4.9 After compliance of all the check points, certify area clearance by signing in appropriate place
Name Designation Signature Date Stamp
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 4 of 10
provided in BPR.
4.10 If any discrepancies found follow point no.4.3 to 4.7.
4.11 Production , Manufacturing:
4.11.1 To ensure the area cleanliness and environmental conditions (temperature, % RH,
differential pressure) are satisfactory.
4.11.2 To ensure the line & machine clearance as per defined procedure.
4.11.3 To check proper filling of sequential log of machine.
4.11.4 To sign status label after ensuring line & machine clearance.
4.11.5 To document the line clearance activity in respective BMR.
4.12 After ensuring the cleanliness and absence of foreign matters in area, Production Officer
should request to QA Officer for line clearance.
4.13 Upon intimation from Production Officer for line clearance, check / verify each and every
activity related to particular operation and record in the respective BMR.
4.14 Common Check Points for all areas:
4.14.1 Inspect general cleanliness of the area. The area should be clean.
4.14.2 The area should be free from any previous batch material or any kind of objectionable
items / materials like scrap poly bags, traces of loose powder of the previous batch,
dust or any other foreign particle.
4.14.3 Ensure that the BMR and other records of the previous batch are removed from the
area.
4.14.4 Check & ensure that all the entries made in the BMR are correct & the BMR is
completed up to the previous stage of processing.
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 5 of 10
4.14.5 Ensure that the area is free from the status labels of the previous batch.
4.14.6 Ensure that the cleaning & sanitization of the area is recorded in the respective log
books.
4.14.7 The area should be free from excess tools / equipment which affect smooth
functioning
4.14.8 Inspect the tools / containers / equipment for cleanliness and absence of previous
batch material. Check the status label on tools / containers / equipment.
4.14.9 Ensure that all the balances and other measuring devices used for the process are
cleaned and calibrated.
4.14.10 Ensure that the calibration of electronic weighing balances and other measuring
devices are recorded in the respective log books.
4.14.11 Ensure that the cleaning of the equipment(s) is recorded in the respective sequential
log books.
4.14.12 Check the temperature & relative humidity of the area. It should be within the limit as
mentioned in the respective BMR.
4.14.13 Check the differential pressure of the area. It should be within the limit as mentioned
in the respective BMR.
4.14.14 Ensure that every persons present in the area wears clean gown, mask and hand
gloves.
4.14.15 In case of product change over check & ensure that the return air riser filters are
cleaned. Ensure that the cleaning of return air riser filters is recorded.
4.1 Granulation area:
5
4.15.1 Inspect general cleanliness of the adjacent areas like air lock, wash room, sifting and
milling area. All the areas should be clean.
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 6 of 10
4.15.2 Cross check the label on the containers of dispensed raw materials for details like
Product name, Product code, Batch No., Item name, Item code, AR No., Container
No., & Quantity against that of mentioned in the Material issue order or Dispensing
sheet.
4.15.3 Ensure that the recovery to be added is released by Q.C.
4.15.4 Cross check the label on the Containers of recovery for details like Product name,
Product code, Batch No., Container No., & Quantity against that of mentioned in the
Test Request for Recoverable recovery.
4.15.5 Check the ID. No. /size of sieve(s) to be used. It should be same as that of mentioned
in BMR. Also check its integrity and cleanliness.
4.15.6 Check the screen of FBD trolley for integrity and cleanliness.
4.15.7 Check the integrity and cleanliness of FBD bags.
4.15.8 In case of product change over, check & ensure that the pre-filters of the FBD are
cleaned. Ensure that the cleaning is recorded.
4.15.9 In case of product change over check & ensure that the pipe, assembly and pre-filters
of the dust collector are cleaned. Ensure that the cleaning is recorded.
4.1 Compression area:
6
4.16.1 Ensure that the lubricated granules are released by Q.C.
4.16.2 Cross check the label on the IPC/Cage blender bin of the granules for details like
Product name, Stage, Batch No., Container No. & Quantity against that of mentioned
in BMR & TEST REQUEST for lubricated granules.
4.16.3 Check the ID. No. of Punch tool to be used. Check that the appropriate set of upper
and lower punches are fitted in the compression machine as per the respective BMR.
4.16.4 In case of product change over check & ensure that the pipe, assembly and pre-filters
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 7 of 10
of the dust collector are cleaned. Ensure that the cleaning is recorded.
4.1 Coating area:
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4.17.1 Ensure that the compressed tablets are released by Q.C.
4.17.2 Cross check the label on the containers of compressed tablets for details like Product
name, Stage, Batch No. Container No. & Quantity against that of mentioned in BMR
& TEST REQUEST for Compressed tablets.
4.17.3 Cross check the label on the containers of dispensed raw materials (coating materials)
for details like Product name, Product code, Batch No., Item name, Item code, AR
No., Container No., & Quantity against that of mentioned in the Material issue order
or Dispensing sheet
4.17.4 In case of product change over check & ensure that the pre-filters of the Coating
machine are cleaned. Ensure that the cleaning is recorded.
4.17.5 Check the integrity and cleanliness of the nylon cloth or SS sieve to be used for
filtration of coating solution
4.17.6 In case of product change over check & ensure that the pipe, assembly and pre-filters
of the dust collector are cleaned. Ensure that the cleaning is recorded.
4.1 Tablet Inspection area:
8
4.18.1 Ensure that the compressed / coated tablets are released by Q.C.
4.18.2 Cross check the label on the containers of compressed / coated tablets for details like
Product name, Stage, Batch No. Container No. & Quantity against that of mentioned
in BMR & TEST REQUEST for Compressed / coated tablets.
4.1 Liquid Manufacturing:
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 8 of 10
9
4.19.1 Inspect general cleanliness of the area, area should be clean.
4.19.2 Check the temperature, % relative humidity and differential pressure of the adjacent
areas like air lock & wash room. It should be within the limit as mentioned in the
respective BMR.
4.19.3 Cross check the label on the containers of dispensed raw materials for details like
Product name, Product code, Batch No., Item name, Item code, AR No., Container
No., & Quantity against that of mentioned in the Material issue order or Dispensing
sheet.
4.19.4 Ensure that the purified water is released by Q.C.
4.19.5 Note: Prior to filtration, ensure that the Bulk is released by Q.C and check filter
integrity before filtration as per the SOP
4.20 De-cartooning Area:
4.20.1 Inspect general cleanliness of the area, area should be clean.
4.20.2 Ensure that the area is free from the primary packing materials of the previous
product.
4.2 Bottle / Vial Washing Area
1
4.21.1 Inspect general cleanliness of the area, area should be clean.
4.21.2 Cross check the label on the containers of dispensed primary packing materials for
details like Product name, Product code, Batch No., Item name, Item code, AR No.,
Container No., & Quantity against that of mentioned in the Material issue order or
Dispensing sheet.
4.21.3 Ensure the parameters for washing and utility should be available as per requirement.
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 9 of 10
4.21.4 Ensure the alignment of nozzles of vial/bottle washing machine and the jet is properly
flushed inside and outside of container.
4.24 Bottle /Container/ Vial Filling& Sealing area:
4.24.1 Cross check the label on the Containers of Filtrate for details like Product name,
Product code, Stage, Batch No., Container No., & Quantity against that of mentioned
in the BMR.
4.24.2 Ensure that the silicon tubes, filling tank, filling assembly and gas needles are cleaned
and kept properly. Ensure that the all cleaned silicon tubes, filling tank, filling
assembly and gas needles are used within 48 hours of the cleaning.
4.24.3 Check the differential pressure of the LAF. It should be within the limit as mentioned
in the respective BMR/SOP.
4.25 After compliance of all the check points, certify area clearance by signing in appropriate place
provided in BMR.
4.26 In case any deviation related to environmental condition is observed, Quality Assurance
designee shall stop the activity and shall inform the Production Officer and Quality Assurance
Head for remedial action. The deviation shall be recorded as per SOP ‘Deviation
Management’ SOP No.: SOP/QA/004/00.
4.27 Any noncompliance related to line clearance is observed, Quality Assurance designee shall
not give the line clearance and shall intimate to Production officer/executive. Production
officer shall rectify the deficiency/noncompliance and request again to QA Officer for
inspection.
4.28 Quality Assurance designee shall re-inspect for the deficiency/noncompliance noticed
originally and shall clear the line for processing after satisfactory compliance.
4.29 If the deficiency/noncompliance not rectified, Quality Assurance designee shall not give the
line clearance and shall intimate to Production Head and Quality Assurance Head for further
action. Quality Assurance designee shall ensure that next processing will not start without QA
line clearance.
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CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00 Reference SOP No.: SOP/QA/001/00
STANDARD OPERATING PROCEDURE
Location Quality Assurance SOP Number SOP/QA/031/00
Version 00
Superseded SOP No. Nil
Title Line clearance for dispensing Effective Date
manufacturing and packaging area Review Date
Page Number 10 of 10
5. RELATED DOCUMENTS
5.1 SOP No.: SOP/QA/004/00 : Deviation Management
6. REFERENCES
6.1 Nil
7. RECORDS
7.1 Nil
8. ABBREVIATIONS
8.1 QA : Quality Assurance
8.2 QC : Quality Control
8.3 BMR : Match Manufacturing Record
8.4 BPR : Batch packaging Record
8.5 BOM : Beloved Material
8.6 AR. No. : Analytical Report Number
8.7 LAF : Laminar Air Flow
9. REVISION RECORD
Version Reason for Revision Effective Date
00 New SOP --------
END OF DOCUMENT
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