1. Write a standard operating procedure for sanitization in Pharmaceuticals.

2. Write a standard operating procedure for equipment cleaning and maintenance.

3. Write a standard operating procedure for sampling of raw materials in pharmaceuticals.

4. Write standard operating Procedures describing in sufficient detail the control procedures

Employed for the issuance of labeling.

5. Write a standard operating procedure for deviation management in Pharmaceuticals.

6. Write a standard operating procedure for cleanliness and zoning policy in pharmaceutical.

7. Write a standard operating procedure for change management in pharmaceuticals.

8. Write a standard operating procedure for reference standard management in Pharmaceuticals.

9. Write a standard operating procedure for document management in pharmaceutical.

10. Write a standard operating procedure for cleaning validation in pharmaceutical.

SOP on Cleaning and sanitization in

pharmaceutical.

1.0 Aim: To lay down the standard operating procedures for cleaning and
sanitization of manufacturing and primary packing area.
2.0 Scope: This SOP is applicable to the entire area in the tablet department
at the plant.
3.0 Responsibility officer:
3.1 Production is responsible for the implementation of this sop.
3.2 Head Production is responsible for compliance with this sop.

4.0 Precautions:
4.1 Avoid standing pull water. Keep the area dry.

4.2 The area having no activity must be cleaned once every working day as
per respective frequency and procedure.

5.0 Procedure for cleaning and sanitization:

5.1 Cleaning and sensitization of area where product directly exposed to
the environment:
5.1.1 Remove unwanted material:
5.1.1.1 Frequency:
 Once in a day at shift end
 Product changeover
 Batch changes over
 Serial cleaning
 After maintenance activity
 Re-cleaning
5.1.1.2 Ensure that accessories or empty drums, or empty containers used
are transferred to the washing area.

5.1.1.3 Ensure that the previous Batch document BMR / BPR is removed from
the area.
5.1.1.4 Ensure that previous batch material is removed from the area.

5.1.2 Ceiling, air inlet, grills, tube light fixtures, cleaning

5.1.2.1 Frequency:
 product changeover
5.1.2.2 Use a ladder for cleaning of the ceiling, air inlet grill, and tube light
fixture dry.

5.1.2.3 clean the ceiling, air inlet grill, and tube light fixture by using a mop
with a lint-free dryer Duster.

5.1.3 Wall cleaning:
5.1.3.1 Frequency:
 Product changeover
5.1.3.2 Clean the wall using a ladder and mop with a dry lint-free Duster.

5.1.4 Electrical fitting pipelines, pendant cleaning :

5.1.4.1 Frequency:
 Product changeover
5.1.4.2 Clean the electrical fitting with a dry lint-free Duster.
5.1.4.3 Wipe pipelines and pendant using a ladder with lint-free Duster (use a
mop with dryer lint-free Duster if required).
5.1.5 Doors, glass panels SS Cupboards racks working table, platform,
pallet cleaning :
5.1.5.1 Frequency:
 Once in a day at shift end
 Product changeover
5.1.5.2 Clean those glasses and Panels using Colin solution and dry lint-free
dry Duster.

5.1.5.3 Clean the SS Cupboards, rack, working table, platform, and pallets by
using a dry lint-free duster.

5.1.6 Waste Bin cleaning:

5.1.6.1 Frequency:
 Once in a day at shift end
 product change over
 Batch changes over
 After maintenance activity
 Recleaning
5.1.6.2 Remove poly bags containing the waste, for example( poly bags,
paper, cable tie, etc.) from the waste Bin and clean the waste Bin with a dry
lint-free Duster.

5.1.6.3 Close the poly bag and transfer it to the scrap area within an
appropriate label.

5.1.6.4 Put the fresh poly bag in the waste Bin for collection of waste.

5.1.7 Floor cleaning with 2% soap solution :

5.1.7.1 Frequency:
 Once in a shift
 Product changeover
 Batch changeover
 After maintenance activity
 Recleaning
5.1.7.2 Dedust the floor using a dry lint-free Duster.

5.1.7.3 Clean the floor covering below machine Foundation, Tables,

Cupboards, etc., using lint-free Duster socked in 2% v/v liquid soap solution.

5.1.8 Floor sanitization:
5.1.8.1 Frequency:
 On a day at Shift end
 During product changeover
5.1.8.2 Sanitize the floor covering below machine Foundation, tables
cupboard, etc., using lint-free Duster shocked in a scheduled disinfectant
solution.

5.1.9 Drain cleaning and sanitization:

5.1.9.1 Frequency:
 At the end of Shift
 Product changeover
Note- Sanitation will only be done if there is no activity in the area.
5.1.9.2 Remove the SS plate and sieve over the drain and “U” trap.

5.1.9.3 Clean SS plate, “U” trap using lint-free Duster soaked in 2% v/v liquid
soap solution.

5.1.9.4 Rinse with soft water.

5.1.9.5 Flush the drain with about 20-litre soft water.

5.1.9.6 Pure 2.0 liter of the disinfectant solution in the gully trap.

5.1.9.7 Use the disinfectant solution on an alternate weekly basis prepares as

per the standard operating procedure for the preparation of the disinfectant
solution.

5.1.9.8 Assemble the sieve and “U” trap.

5.1.9.9 Cover the drain with the SS plate.

5.1.9.10 Record the cleaning detail as per annexure “cleaning and sanitization
record of area where product directly exposed to environment.”

5.2 Clean and sanitization of the area where the product does not
directly expose to the environment:
5.2.1 Remove unwanted material.
5.2.1.1 Frequency:
 Once in a day at Shift end.
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5.2.1.2 Remove the unwanted material.

5.2.2 Ceiling, air inlet grill, tube light fixtures cleaning:

5.2.2.1 Frequency:
 Once in a fortnight at shift end.
5.2.2.2 Clean ceiling, air inlet grille, tube light fixture once.

5.2.3 Wall cleaning:
5.2.3.1 Frequency:
 Once in a day at shift end.
5.2.3.2 Clean the wall using a ladder and mop with a dry lint-free Duster.

5.2.4 Electrical fitting, pipelines, pendants cleaning:

5.2.4.1 Frequency:
 Once in a fortnight at shift end
5.2.4.2 Clean the electrical fitting with a lint-free duster, pipeline, and pendant
with net protector doors.

5.2.5 Glass, panels, SS cupboard, racks, working table, platform pallet

cleaning :
5.2.5.1 Frequency:
 Once in a day at shift end
5.2.5.2 Clean those glasses and Panels using Colin solution and lint-free dry
Duster. Clean SS Cupboard, working table, platform, and pallet using dry lint-
free Duster.
5.2.6 Waste Bin cleaning:
5.2.6.1 Frequency:
 Once in a day at Shift end
 Clean the waste Bin as mention in the steps above
5.2.7 Floor cleaning: with 2% soap solution:
5.2.7.1 Frequency:
 Twice a day during a lunch break.
 At the end of Shift.
5.2.7.2 Clean the floor using a dry lint-free duster, clean the floor covering
below SS pallet, table, cupboard, etc., using lint-free Duster deep in 2% V/V
liquid soap solution.

5.2.8 Floor sanitization:
5.2.8.1 Frequency:
 Once in a day at Shift end.
5.2.8.2 Sanitize the floor covering below as pallet, table, cupboard, etc., using
lint-free Duster soft in a disinfectant solution.

5.2.9 Drain cleaning and sanitization:

5.2.9.1 Frequency:
 During lunch break
 At the end of Shift
5.2.9.1 To clean and sanitize the drain

5.2.9.1 Remove the SS plate and sieve over the drain and “U” trap.

5.2.9.1 Clean SS plate, “U” trap using lint-free Duster soaked in 2% v/v liquid
soap solution.

5.2.9.1 Rinse with soft water.

5.2.9.1 Flush the drain with about 20-litre soft water.

5.2.9.1 Pure 2.0 liter of the disinfectant solution in a gully trap.

5.2.9.1 Use the disinfectant solution on an alternate weekly basis prepares as
per the standard operating procedure for the preparation of the disinfectant
solution.

5.2.9.1 Assemble the sieve and “U” trap.

5.2.9.1 Cover the drain with the SS plate.

5.2.9.1 Record the cleaning detail as per annexure cleaning and sanitization
record of area where the product does not directly expose to environmental
cleaning and sanitization of the area where the product is directly exposed to
the environment.

5.3 Calibration of equipment and instrument by external party:

5.3.1 After external party calibration, cleaning is to be performed as per a
schedule of running and is to be updated in a Records, “cleaning, and
sanitization of manufacturing and primary packing area.”
5.3.2 Remarks column is to be done an update with appropriate comment
cleaning and sanitization of the area where the product does not directly
expose to the environment after calibration of equipment and instrument by an
external party.

5.3.3 After external party calibration, cleaning is to be performed as per

schedule, on (once in a day at shift end) and is to be updated in another
cleaning and sanitization of manufacturing and primary packing area remark
in the column is to be updated with stable comment.

Annexure-I