STANDARD OPERATING PROCEDURE Restricted Circulation
| XYZ
Pharmaceuticals Limited |
TITLE | SOP No : XYZ | |
| GOWNING & DEGOWNING PROCEDURE FOR ENTERING IN Q.C. DEPARTMENT | Revision No.: 00 | ||
| Location : |
Effective Date: |
||
| Dept.: Quality Control |
Supersedes: New Introduction |
||
| Area: Quality Control Lab. | Review Date: | ||
| Prepared by | Checked by | Approved by | |
| Name | |||
| Signature | |||
| Date | |||
1 OBJECTIVE
To lay down a correct procedure for Gowning and Degowning in Quality Control Laboratory.
2 SCOPE
This SOP shall be applicable for all employees/visitors entering in Quality Control Laboratory at XYZ Pharmaceutical Ltd
3 RESPONSIBILITY
3.1 Execution: All QC personnel/Visitor
3.2 Checking: Asst. Manager and above-QC Department
4 ACCOUNTABILITY
Head of the QC Department
5 PROCEDURE
5.1 Gowning: Gowning is a change of dress or to put on dress/company’s uniform while entering into a specified clean area to avoid contamination.
5.1.1 Gowning shall be strictly followed by all the employees/visitors.
5.1.2 Upon entering the QC Dept. clean/wipe the soles of your shoes using “Sticky Mat” located on the floor just at the entrance.
5.1.3 Remove street shoes and keep it in the designated blue shoe locker lying in change room and wear company footwear.
5.1.4 Enter into the washroom and wash hands with liquid soap. Dry hands with the hand drier
5.1.5 Before entering into the clean working area, keep the slipper back into the designated shoe locker
lying in change room. Come on the other side of the crossover bench and open the designated
clean area locker (white coloured), take out the clean slipper and wear them .
5.1.6 Visitors shall put on shoe covers on their street shoes.
5.1.7 Remove your clean apron from the cabinet, and wear over the street dress.
5.1.8 Place your belongings or unnecessary items in respective lockers provided to you.
5.1.9 Take only necessary/allowed items into the clean room areas.
5.1.10 Use full size mirror in gowning/change room to inspect that all your clean room apparels are appropriately fitted.
5.1.11 While entering into the working area, ensure that outside door has been properly closed. Do not block or hold the door open for the next person.
5.2 Degowning: Degowning is to take off your company’s uniform while going out from the clean area.
5.2.1 After leaving the work place, wash the hands as per SOP No.: ABC
5.2.2 Make an entry into a change room/gowning room.
5.2.3 Take off your apron and place it back in its designated rack/place.
5.2.4 Put off the used apron after every alternate day & keep it into a bin provided for collecting “Soiled Linen” in the change room.
5.2.5 Take out your company’s footwear and place it back in the designated area/rack. Wear your street shoes.
5.2.6 Shoe covers shall be thrown/discarded into a “Waste Bin.”
5.2.7 Disposal gloves shall be discarded into a waste container.
5.2.8 Take back your belongings and exit the change room ensuring that the door is pulled tightly behind you.
5.2.9 Regular users may hang gloves, safety goggles, caps, and facemask which can be reused upto three times, but always discarded after heavy wear up in a designated area.
6.0 REFERENCES
| SOP No. | Title of SOP |
| ABC | Hand Wash Procedure |
7.0 ANNEXURES
Not Applicable
8.0 ABBREVIATIONS
SOP : Standard Operating Procedure
No. : Number
Dept. : Department
QC : Quality Control
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