Procedure for Entry and Exit in Production Area

1. OBJECTIVE
To lay down the procedure for Entry and Exit in Production Area

2. SCOPE
This procedure is applicable to all sections of Production

3. RESPONSIBILITY
• QA Officer
• Production Pharmacist/ Above

4. SAFETY INSTRUCTIONS
• N/A

5. PROCEDURE
5.1 Growing procedure is followed as per SOP.
5.2 Gowning For Entry
5.2.1 Only Authorized person are allowed to enter in plant
5.2.2 Enter into the change room of production area
5.2.3 Remove the street footwear ad keep the street footwear in the shoe locker provided in the change room
5.2.4 Step over the bench and wear the plant uniform and another pair of sleeper in the following sequence: –
Wear the cap.
Wear the pant and shirt.
Wear the plant sleeper.
5.2.5 Observe yourself in the mirror and ensure that hair is completely covered under cap and properly gowned.
5.2.6 Sanitized the hands with the disinfectant.
5.2.7 Enter the plant corridor through the air lock.
5.2.8 From this corridor proceed to respective floor depending upon the nature of job.
5.3 De-gowning For Exit
5.3.1 Warehouse & packing persons enter into the exit change room.
5.3.2 Persons who are involved in manufacturing must come through Air Shower for De-Dusting.
5.3.3 Press the push button of door interlock and enter in to the air lock.
5.3.4 Press the push button of door interlock and enter in to the common change room.
5.3.5 Remove the plant uniform and sleeper and put it in the locker provided.
5.3.6 Dispose the plant uniform in the bin provided for further washing at the end of shift and sleeper kept in locker.
5.3.7 Step over the bench and wear the street clothes from the respective locker.
5.3.8 Push the door and come out from the common change room.
5.3.9 Take out the street footwear from the locker and wear the same.
5.3.10 Use the wash room, wash and dry the hands.
5.3.11 Come out from the plant through plant personnel entry door.

6. RELATED DOCUMENTS
N/A

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
QA Quality Assurance
SOP Standard Operating Procedure

9. REVISION HISTORY