1.0
OBJECTIVE:
To lay down
the procedure for line clearance before starting any stage Manufacturing
operations in manufacturing and warehouse area. This is to ensure that the
start up of any production / process is free from previous material
/contaminants.
2.0
SCOPE:
This SOP is applicable for line clearance of Production
(Tablets), Production (Capsules), Production (Ointment), and warehouse areas of
Formulation plant of ---------------------------------------
3.0
RESPONSIBILITY:
3.1
Operator/Supervisor
shall be responsible for proper cleaning of equipment /area.
3.2
Production
Chemist/Officer and originating department shall be responsible for checking
the cleanliness of the area/equipment.
3.3
IPQA Officer
shall be responsible for giving Line Clearance and complies of this SOP.
4.0
ACCOUNTABILITY:
4.1
The
Accountability lies upon all originating department for Complies of this SOP.
4.2
QA Head - accountability
for implementation and complies of this SOP.
5.0
PROCEDURE:
5.1
After area is
checked and found appropriate by production personnel they should intimate the
IPQA personnel for Line Clearance.
5.2
After getting
the intimation form production, IPQA person should ensure following points.
5.3
Ensure the
cleaning of entire area and equipment after every product/batch changeover as
per their respective SOP.
5.4
Ensure that
the area cleaning should be done as mentioned in the SOP for cleaning of the
respective area.
5.5
Ensure that
there are no traces of labels, scrap/material of the previous product.
5.6
Ensure the
removal of all the documents/materials not required for the planned process.
5.7
Ensure the
room temperature and relative humidity is as per specified limit.
5.8
Ensure the
room differential pressure is as per specified limit.
5.9
Ensure that
riser filters are cleaned after every product changeover.
5.10
After
cleaning of the area and equipment ensure visually that the cleaning is
appropriate & verify the balance and check its records.
5.11
Cleaning
shall be checked by the officer of the concern department and IPQA personnel
shall verify.
5.12
In case there
is any previous product traces, re-perform the cleaning procedure unless the
area/equipment is cleaned properly.
5.13
After proper
cleaning of equipments / area, production personnel shall intimate to IPQA
personnel along with intimation slip for collection of swab / rinse sample, if
required.
5.14
After receipt
of the swab / rinse report from QC
department as approved, IPQA personnel
shall verify the report and give the line clearance as per BMR & BPR
and simultaneously sign in the BMR & BPR
5.15
In case swab
report has failed, re-perform the cleaning and analysis till cleaning is
satisfactory.
5.16
After
verification of all required check points, IPQA personnel shall give the
line clearance.
5.17
If there is
breakdown of more than ½ Hr in between any process of production, then the line
clearance should be taken again
5.18
Machine /
Line clearance is required for the following stages and not limited:
·
Dispensing of raw
materials.
·
Dispensing of
packing material
·
Conversion of
bulk into respective dosage form e.g. Granulation, compression, coating,
capsule filling, etc.
·
Blister and strip
packing machine.
·
Packing lines.
5.19
Residual
recovery / Balance material, if any of previous product are removed from the
area and kept under lock and key / destroyed.
5.20
All used hand
gloves, dusters of previous product are removed from line.
5.21
Waste bin for
waste is emptied.
5.22
Ensure that
the equipment is clean, affixed with “Cleaned” status label and is within the
“Use before date”.
5.23
Line clearance at the time of overprinting/over coding
5.23.1
Check that
the defined area is clean.
5.23.2
Check that
the remnants and rubber stereos of the previous product are removed.
5.23.3
Check that
the equipment is clean, it bears status label as ‘Cleaned’.
5.23.4
Check the
coding details of the carton / label against the coding information. Get it
counter checked by QA person. Affix the signed specimen with the BPR.
5.23.5
The technical
supervisor of production and quality assurance signs the specimen.
5.24
Acceptance criteria: Area and equipments should be free from any residue of
previous product.
5.25
Frequency: Whenever required.
6.0
LIST OF ANNEXURE AND FORMATS:
|
Sr. No. |
Title of Format |
Format No. |
|
01 |
Respective Product Batch Manufacturing Record |
As per the
Product |
7.0
REFERENCES:
7.1
SOP-QA-001
7.2
F/QA-001-01
7.3
SOP-QA-014
8.0
REVISION HISTORY:
|
Sr. No. |
Date |
Reason for Revision |
Revision No |
|
1.
|
31/10/2018 |
New SOP |
R0 |
|
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
|
Sr. No |
Abbreviations |
Details |
|
|
SOP |
Standard operating procedure |
|
|
QA |
Quality Assurance |
|
|
QC |
Quality Control |
|
|
BMR |
Batch Manufacturing Record |
|
|
BPR |
Batch Packing Record |
|
|
IPQA |
In-process Quality Assurance |
|
|
LC |
Line Clearance |
END OF DOCUMENT
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Pharmaceutical guideline only