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.
