Quality Assurance

Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store

Cleaning of Raw Material Store, Packing  Material Store and

Finished Goods Store

Objective

To lay down a procedure for Cleaning of Raw Material Store, Packing Material Store

and Finished Goods Store.

Scope

This Standard Operating Procedure is applicable for Cleaning of Raw Material Store,

Packing Material Store and Finished Goods Store at formulation plant

Responsibility

Concerned Department personnel shall be responsible to follow the procedure

mentioned in this SOP.

Concerned Department in-charge shall be responsible for implementation of

the procedure mentioned in this SOP.

Accountability

Concerned Department in-charge & QA Head shall be accountable for the

implementation of this SOP.

 

Procedure

Collect all the waste material, dust settled over tables, floors, containers, furniture, fixtures &

walls with the help of vacuum cleaner.

Clean the door, window glasses, door closures, handles and all the hinges of the door using

clean dry duster followed by wet duster and again with dry duster.

If weighing balance is present in the processing room, clean it by using wet duster

followed by dry duster.

Clean the pallets, trolleys, etc. using a wet duster followed by a clean dry duster.

Remove the dust from the switchboards, utility pendants using the vacuum cleaner.

Clean the SOP stand using clean dry duster.

Clean the accessories box using the wet duster followed by clean dry duster.

Clean the ceilings of Air Handling Unit (AHU) supply/return grilles with a pipe brush and

vacuum cleaner (if applicable).

Clean the ceiling of whole area including racks, shelves using wet duster followed by

a clean dry duster.

Clean and mop the entire floor twice using disinfectant solution (2.5 % Dettol/Savlon)

or any other disinfectant (if required) 7.

Clean the tube light fixtures using wet duster followed by a clean dry duster.

Clean the walls, coving, corners of the entire area using wet duster followed

by clean dry duster.

Clean the cameras of the entire area using wet duster followed by clean dry duster.

Collect all the waste from the waste bin into a poly bag and send to the scrap area.

Clean the waste bin with wet duster followed by clean dry duster.

Clean the drain points using disinfectant solution.

Enter the cleaning activity details in the Area Cleaning Log Book.

Frequency: Twice a day or as when required

Abbreviations and Definitions

SOP: Standard Operating Procedure; a document where step-by-step instructions

are cited to serve as support for methods or manners of fulfilling a function or

functions reliably and consistently.

Wet duster : soaked with disinfectant solution

QA : Quality Assurance

RM : Raw Material

AHU :Air Handling Unit

Forms and Records (Annexures)

Area Cleaning Log Book  –   Annexure-I

Distribution

Master copy –    Quality Assurance

Controlled copies  –     Quality Assurance, Stores

History

Annexure-I

Area Cleaning Log Book 

Area Name:                                              Cleaning Frequency:

Sr NoCheck PointDate
1Cleaning of entire floor using disinfectant solution (2.5 % Dettol/Savlon) or any other disinfectant (if required)Schedule
2Cleaning of doors, window glasses, door closures, door handles and all hinges of doors using dry duster followed by wet duster and again dry duster.
3Cleaning of trolleys, pallets etc. using wet duster followed by dry duster.
4Cleaning of Weighing Balance if present using wet duster followed by dry duster.
5Cleaning of accessories box using wet duster followed by dry duster.
6Cleaning of switchboards, utility pendants using vacuum cleaner.
7Cleaning of walls, coving, racks, shelves, tube fixtures with wet duster followed by dry duster.
8Cleaning of AHUsupply/return grills with a pipe brush and vacuum cleaner.
9Cleaning of drain points using disinfectant solution.
10Cleaning of SOP stand with dry duster.
11Collection of all the waste from the waste bin into a poly bag and transfer to the scrap room. Cleaning of   waste bin with wet duster followed by dry duster.
Done By
Checked By
Note: All the observations of cleaning shall be recorded in cleaning record. If the cleaning activity  is satisfactory write ‘OK’, if not satisfactory write ‘NOT OK’ and if  not applicable  write ‘NA’

 

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ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube