Professional Documents
Culture Documents
AMENNDMENT SHEET
WRITTEN BY QC OFFICER
APPROVED BY QC MANAGER
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
CONTENTS
2.0 PURPOSE…………………………………………………..…03
3.0 OBJECTIVE……………………………………………….…...03
6.0 TERMS………………………………………….……….….....04
7.0 DEFINITIONS………………………………….……….….....04
9.0 DISTRIBUTION………………………………….……….…....12
10.0 ANNEXURES…………………..……………….……….…....12
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
2.0 PURPOSE:
3.0 OBJECTIVE:
The objective of this SOP is to ensure that complete facility is clean & free from all sort of
contamination.
3.0 SCOPE:
5.0 RESPONSIBILITY:
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
5.7 Quality Assurance Manager shall be responsible for:
5.7.1 Approving cleaning/sanitization agents for use in facility.
5.7.2 Approving the cleaning and sanitization Environmental Monitoring (EM)
program
5.7.3 Ensuring the facility areas, rooms and/or equipment are inspected (as required)
for clearance / cleaning effectiveness, post-cleaning and before the start of
production.
5.7.4 Initiating and leading quarterly meetings attended by Director Operation, Ware
House Incharge, Production Manager & QC Manager and other relevant
stakeholders to review EM Program results and trends using this information to
modify the facility and equipment cleaning/sanitization procedures to maintain
and/or improve their effectiveness.
5.7.5 Ensuring periodic verification (minimum monthly) of cleaning/sanitization
documentation prepared by cleaning/sanitization personnel for accuracy and
compliance.
5.7.6 Reviewing and approving investigations involving cleaning/sanitization.
6.0 TERMS:
7.0 DEFINITION:
7.1 Cleaning:
7.1.1 The removal of residual product or extraneous matter including microbial
contamination from the facility surfaces and/or equipment to an acceptable level
and maintaining the condition of the facility or equipment such that it can be used
safely for subsequent use.
7.5 cGxP:
7.5.1 cGxP is a general term that stands for current Good “x” Practice (x =
Clinical,Engineering,Laboratory,Manufacturing,Documentation,Pharmaceutical,
etc.).
7.5.2 The titles of these Good “x” Practice guidelines usually begin with “Good” and
end in “Practice”. cGxP represents the abbreviations of these titles where “x” a
common symbol for a variable, represents the specific descriptor.
7.6 HAZOP :
7.6.1 Hazard and Operability Analysis is a structured and systematic technique used
for system examination and risk management to identify potential hazards in the
system and identify operability issues that could lead to nonconforming product.
7.8 Sanitization:
7.8.1 The act or process, physical or chemical, of reducing viable organisms on a
surface to a defined acceptable level.
7.8.2 Sanitizing is accomplished with either heat, radiation or chemicals.
7.8.3 Unless the item to be sanitized is effectively cleaned,
7.8.4 it is difficult to obtain close contact between the sanitizer and the surface to the
sanitized.
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
Cleaning Schedule :
o For core area:
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
Note : In case of maintenance of area, area shall clean thoroughly as per respective cleaning
procedure.
Cleaning procedure during product changeover in core area :
o Ceiling : Clean the ceiling with the help of clean dry lint free duster.
o Walls : Clean the wall with the help of wet duster soaked in potable water.
o Risers:
Open the risers grills and clean in same area or take out to the washing area
covered with poly bag.
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
Clean the duct of the risers using potable water.
Clean the riser grill using potable water and dry with compressed air.
o Stainless steel Guards, Doors, door closer, SOP stand, Thermo -hygrometer
and Magnehelic gauge :
Clean the Stainless steel Guards, Doors and door closer with wet cloth
soaked with potable water followed by dry with clean dry cloth.
Clean the SOP stand, Thermo hygrometer, Magnehelic gauge with wet cloth
soaked with potable water followed by dry with clean dry cloth.
Other accessories (Tables, Stools, Granite, Accessories stand, Trolley, Sample box
etc.):
o Clean with the help of clean dry lint free cloth followed by wet cloth soaked in non
ionic detergent solution.
o Then clean with the help of wet cloth soaked in potable water followed by with
clean dry lint free cloth.
Waste bin :
o Put all the waste materials or debris in waste bin during activity.
o Remove poly bag from waste bin and send to scrap yard.
o Clean the waste bin with wet cloth or with potable water followed by with dry cloth.
o Place a new poly bag in waste bin.
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
Note: Use 10% Multi Surface Cleaner solution and 2.5% Dettol alternatively every three days for
sanitization of floors.
Cleaning procedure at the end of shift or batch to batch changeover or as and when
required for core area :
o Stainless steel Guards, Doors and door closers, SOP stand, thermo hygrometer,
Magnehelic gauge: Clean the Stainless steel Guards, Doors and door closers with
dry cloth.
o View panels of doors & windows: Clean the view panels with dry cloth.
o Electrical panel, switches, balance and balance cable, PLC of
equipment: Switch off the main supply and remove the plug before cleaning. Clean
the panels, switches, balance and balance cable, PLC of equipment with dry cloth.
o Waste bin: Remove poly bag from waste bin and Clean the waste bin with wet cloth
followed by with dry cloth and then placed a new poly bag in waste bin.
o Other accessories (Tables, Stools, Granite, Accessories stand, Trolley, Sample
box etc.): Clean the panels with dry cloth.
o Floor & Coving :
Collect all the waste materials like papers, threads, gloves lying on the floor
in waste bin.
Then wipe the floor & coving with rubber wiper and collect all waste
materials like tablets / capsules / powder / pellets in waste bin,
In case of core area, where product is inside the cubicle, if any.
In core area without product, disinfectant shall be used as per the schedule.
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
The floor shall be disinfected by mopping and during disinfection mopping
always ensures that strokes are 10-25% overlapping.
Check and ensure the complete cleanness of floor and area.
Ensure that no debris like paper or thread to remain on the floor.
Cleaning procedure for other than core area :
o Stainless steel Guards, Doors, door closers, SOP stand, thermo hygrometer,
and Magnehelic gauge:
Clean the Stainless steel Guards, Doors, door closers, SOP stand, thermo
hygrometer and Magnehelic gauge with dry cloth.
o View panels of doors & windows:
Clean the view panels with dry cloth or with potable water and then wipe
with rubber wiper.
o Waste bin:
Remove poly bag from waste bin and Clean the waste bin with wet cloth
followed by with dry cloth and then placed a new poly bag in waste bin.
o Other accessories (Tables, Stools, Granite, Accessories stand, Trolley, Sample
box etc.) :
Clean the panels with dry cloth.
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
Cleaning of washing room is to be carried out at the end of
each shift.
Mop out the excess water from the area using rubber scrapper.
Use 10% Multi Surface Cleaner solution and 2.5% DETTOL
alternatively every three days for sanitization of floors.
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
9.0 DISTRIBUTION:
o Production
o Maintenance
o Quality Assurance
o Ware House
10.0 ANNEXURE:
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
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SN/QC/SOP/042
Department Quality Control Issue # 0 1
Section Quality Control Issue Date 1 2 - 2 0 1 9
STANDARD OPERATING PROCEDURE
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