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 Raw Material stores, Packing Material Store and Finished Goods Stores at the formulation plant.

Responsibility

  • Concerned Department personnel shall be responsible to follow the procedure mentioned in this SOP.
  • The concerned Department in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

  • The concerned Department in charge & QA Head shall be accountable for the implementation of this SOP.

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 UnitMaterial

Procedure

  • Collect all the waste material, the dust settled over tables, floors, containers, furniture, fixtures & walls with the help of a 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 a dry duster.
  • If a weighing balance is present in the processing room, clean it by using a 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 a clean dry duster.
  • Clean the accessories box using the wet duster followed by a 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 the whole area including racks, shelves using a 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) as per SOP.
  • Clean the tube light fixtures using a 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 a wet duster followed by a clean dry duster.
  • Collect all the waste from the waste bin into a polybag and send it to the scrap area. Clean the waste bin with a wet duster followed by a clean dry duster.
  • Clean the drain points using the disinfectant solution.
  • Enter the cleaning activity details in the Area Cleaning Log Book.
  • Frequency: Twice a day or as when required

Forms and Records (Annexures)

  • Area Cleaning Log Book                              –                        Annexure-I

Distribution

  • Master copy          –    Quality Assurance
  • Controlled copies        –     Quality Assurance, Stores

History

DateRevision Number
Reason for Revision

Annexure-I

Sr No.Check PointDate       
ScheduleE
1.Cleaning of the entire floor using disinfectant solution (2.5 % Dettol/Savlon) or any other disinfectant (if required) as per SOP.
2.Cleaning of doors, window glasses, door closures, door handles, and all hinges of doors using dry duster followed by wet duster and again dry duster.
3.Cleaning of trolleys, pallets, etc. using wet duster followed by dry duster.
4.Cleaning of Weighing Balance if present using wet duster followed by dry duster.
5.Cleaning of accessories box using wet duster followed by dry duster.
6.Cleaning of switchboards, utility pendants using a vacuum cleaner.
7.Cleaning of walls, coving, racks, shelves, tube fixtures with wet duster followed by dry duster.
8.Cleaning of AHUsupply/return grills with a pipe brush and vacuum cleaner.
9.Cleaning of drain points using the disinfectant solution.
10.Cleaning of SOP stands with a dry duster.
11.Collection of all the waste from the waste bin into a polybag 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 the cleaning record. If the cleaning activity  is satisfactory write ‘OK’, if not satisfactory write ‘NOT OK’ and if  not applicable  write ‘NA’

About 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

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