SOP For House Keeping Personnel Movement in Manufacturing Facility

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1.0 Objective: 

To lay down a procedure for house keeping personnel movement

2.0 Scope: 

This SOP is applicable to house keeping personnel for guiding them concerning their movement in manufacturing facility (Production – Oral & Ware house) in pharmaceutical company.

3.0 Responsibility

3.1 House keeping personnel is responsible for cleaning of respective areas

3.2 In charge – Housekeeping is responsible for cleaning of respective areas and coordination for their movement

3.3 Officer/Above of concerned department is responsible for monitoring effectiveness of  cleaning

4.0 Accountability

Head of concerned department/Head-QA shall be responsible for compliance of SOP

5.0 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.

No.      :           Number

6.0 Procedure

6.1 Every house keeping personnel must maintain hygienic condition as per SOP on Health and hygiene of plant personnel.

6.2 Every house keeping personnel shall under go for training for the functions

6.3 Every house keeping personnel shall be aware of entry and exit procedures of applicable areas as per respective SOP’s.

6.4 Before taking cleaning activity, the house keeping personnel shall follow good gowning practices like cleaned garments, eye goggles, hand gloves, nose masking, booties/ plant footwear.

6.5 House keeping personnel shall perform their activities by following SOP for cleaning of packing hall, ware house and change room and SOP for cleaning of primary production area.

6.6 Disinfectants used for cleaning shall be rotated on weakly basis as per SOP on disinfectant usage policy.

6.7 House keeping personnel is requested to select suitable cleaning aids, which are based on type of cleaning as where applicable. Cleaning aids which are applying must be lint free, non shredding and non reactive with disinfectant.

6.8 Carry the cleaning activity by moving in order as per flow chart shown mentioned  Annexure no – I and Annexure –II which directs the house keeping personnel to access ( way of entry ) the area easily.

7.0 Forms and Records (Annexures)

7.1 Flow chart of house keeping for primary change room, primary corridor , secondary packing hall & ware house   –    Annexure-I

7.2 Flow chart of house keeping for primary production area (Oral) & RM ware house dispensing and sampling area     –   Annexure-II

8.0      References (if any)

7.1      SOP for cleaning of primary production area

7.2      SOP for cleaning of secondary packing hall, ware house and change room

9.0 Distribution

8.1 Master copy –           Quality Assurance

8.2 Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering, HR.

10.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

 

Flow chart of house keeping for primary change room, primary corridor, secondary packing hall & ware house

 Annexure-I

Cleaning to be done by             Name of the Area          Select Cleaning technique whichever is suitable

Disinfectant Solution                 Primary Change Room                       Mopping, scrubbing and Wiping

Disinfectant Solution                   Primary Corridor                                Mopping, scrubbing and Wiping

Disinfectant Solution                 Secondary Packing Hall                      Mopping, scrubbing and Wiping

Disinfectant Solution                 Finished Good Ware House                 Mopping, scrubbing and Wiping

Disinfectant Solution                  Raw material ware house                   Mopping, scrubbing and Wiping

expect dispensing and sampling area

Note: Disinfectant shall be used by rotating/changing on weakly basis, for preparation of disinfectant Refer SOP (SOP on Disinfectant usage policy), disinfectants like Savlon 2.5% v/v, Domex 5% v/v and Lyzol 5%v/v shall be employed for above mentioned areas.

 Annexure-II

Flow chart of house keeping for primary production area (Oral) & RM ware house dispensing and sampling area

Cleaning to be done by             Name of the Area          Select Cleaning technique whichever is suitable

Disinfectant Solution                 Secondary Change Room                       Mopping, scrubbing and Wiping

Disinfectant Solution     Corridor adjacent to primary packing section     Mopping, scrubbing and Wiping

Disinfectant Solution   Strip packing room plus change parts room    Mopping, scrubbing and Wiping

                                                  including air lock

Disinfectant Solution           Alu-Alu packing room (BQS) plus change         Mopping, scrubbing and Wiping

                                                   parts room including air lock

Disinfectant Solution                    Alu-Alu packing room                                      Mopping, scrubbing and Wiping

                                                 plus change parts room

Disinfectant Solution              Main Corridor between capsule filling              Mopping, scrubbing and Wiping

                                                            and coating room

Disinfectant Solution                 Coating room and change parts room          Mopping, scrubbing and Wiping

including air lock

Disinfectant Solution                   Table inspection room including air lock      Mopping, scrubbing and Wiping

Disinfectant Solution                      Compressed tablets quarantine                Mopping, scrubbing and Wiping

including air lock

Disinfectant Solution                     Compression room including                     Mopping, scrubbing and Wiping

compressed tablets quarantine                  Mopping, scrubbing and Wiping

Disinfectant Solution                                        IP QA                                       Mopping, scrubbing and Wiping

Disinfectant Solution                     Tablet punch room & Granules                    Mopping, scrubbing and Wiping

quarantine area

Disinfectant Solution                     Quarantine room for tablets/capsule          Mopping, scrubbing and Wiping

Disinfectant Solution                    Capsule filling room including air lock           Mopping, scrubbing and Wiping

Disinfectant Solution                      Wet granulation including air lock and           Mopping, scrubbing and Wiping

dispensed material store room

Disinfectant Solution                        Dry granulation including air lock and         Mopping, scrubbing and Wiping

dispensed material store room

Disinfectant Solution                 RM Ware house sampling area                        Mopping, scrubbing and Wiping

including air lock

Disinfectant Solution               RM Ware house dispensing booth                        Mopping, scrubbing and Wiping

and area including air locks

Note: Disinfectant shall be used by rotating/changing on weakly basis, for preparation of disinfectant Refer SOP (SOP on Disinfectant usage policy), disinfectants like Savlon 2.5% v/v, Domex 5% v/v and Lyzol 5%v/v shall be employed for above mentioned areas.

 

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