Learn about the Standard operating procedure for “Entry and Exit Procedure in Pharmacautical” along with Purpose, Scope, Responsibility, Instruction, Procedure, Entry procedure for employees, Exit procedure for the employees, and Entry and Exit procedure for visitors.
1.0 Purposes: 1.1 Lay down the standard operating procedure for the entry-exit procedure in pharmaceuticals.
2.0 scope: 2.1 This SOP applies to all personnel, including visitors entering or leaving the production area of the main plant.
3.0 Responsibility: 3.1 All personnel entering and leaving the production area are responsible for adhering to this SOP.
3.2 The P&A Supervisor is responsible for providing cleaned linen and footwear.
3.3 Head P&A and quality assurance are responsible for ensuring overall compliance with this SOP.
4.0 Instructions Entry-exit Procedure:
4.1 Before the take entry into a change room, put all the edible, chewable, and beverages in the dining hall. Eating and chewing are prohibited inside the production area.
4.2 Primary linen shall be changed periodically or if it is wet, dusty, or dirty.
4.3 Visitors shall be accompanied by an authorized person of the company who shall guide them regarding entry and exit.
4.4 In case of emergency exit, used linen should be discarded in the “used linen Bin,” and fresh linen should be worn and follow steps 5.1.11 to 5.1.17 to enter the production area.
4.5 in case the authorized signature in the pictorial of the change room gets wiped off during the cleaning and sanitization activity. The concerned authority shall sign the same on the current date after checking the procedure.
Related SOP – SOP on the training of personnel
5.0 Procedure for Entry-exit in Pharma:
5.1 Entry procedure for employees:
5.1.1 To enter the changing room, make sure street shoes are dust-free.
5.1.2 Remove and keep Street footwear in the shoe rack provided.
5.1.3 Keep the person belongings like a wristwatch, Ornaments, wallet purses, and sticker bindis in the personal locker provided for the purpose. These items are prohibited in the production and warehouse areas.
5.1.4 Ensure that feet are dust-free and clean well on the feet mate provided before entering the change room.
5.1.5 Inter in the change room Primary, remove the street cloth and keep it in the cupboard provided for the purpose.
5.1.6 Wear the slippers provided in the changing Primary room for the washroom area.
5.1.7 Wash hands with a soap solution and water in the washroom.
5.1.8 Dry hands by using a hand dryer (use a paper napkin if required).
5.1.9 Remove the sleeper and keep it in the rack provided outside the washroom.
5.1.10 Rub the bare feet over the tacky foot mat provided.
5.1.11 Wear the factory footwear while crossing over the crossover bench.
5.1 12 Take out the boiler suit and Cap from the personal locker provided in the next change room.
5.1.13 Wear the first Cap and then the boiler suit.
5.1.14 Wear the Cap while adjusting hair well inside the Cap and wear a beard mask (if required).
5.1.15 Heck the full attire for proper dress-up in the mirror.
5.1.16 Inter in Buffer change room, disinfect Hands by using the disinfectant solution provided.
5.1.17 Inter in the production area.
Related SOP: Procedure for staff, visitors
5.2 Exit procedure for the employees:
5.2.1 Inter the change room through a buffer change room.
5.2.2 Remove the boiler suit and cap and keep them in the personal locker provided.
5.2.3 Remove factory footwear and keep it in the rack provided while crossing the cross over the bench.
5.2.4 Take out the street cloth from the cupboard and wear it in the changing room.
5.2.5 Inter into the primary change room.
5.2.6 Collect personal belongings from personal lockers.
5.2.7 Wear street footwear.
5.2.8 Open the door to exit from the changing room.
5.3 Entry and exit procedure for visitors:
5.3.1 Deposit personal belongings in the box provided in the administration area.
5.3.2 Rub the shoes over the foot mat provided at the entry stage to ensure that all the dust particles are properly removed from the street footwear and inter in the primary change room.
5.3.3 Take the boiler suit, and Cap provided in the next change room.
5.3.4 Wear first the Cap and then the boiler suit.
5.3.5 Follow step 5.1.14 to know how to wear a cap.
5.3.6 Check the full attire for proper dress-up in the mirror.
5.3.7 Inter in Buffer change room, disinfect hands by using the disinfectant solution provided.
5.3.8 Inter in the production area.
Note:- Visitors may wear a boiler suit disposable dress over the street clothes and shall be provided with shoe cover while footwear change takes place.
5.3.9 Follow the exit procedure as described in step 5.2.1
5.3.10 Remove the boiler suit and cap and keep them in the bin provided.
5.3.11 Follow steps 5.2.4 and 5.2.5
5.3.12 Remove the shoe covers.
5.3.13 Open the door to exit from change room A.
5.3.14 Collect personal belongings from the box in the administration area.
Related SOP: SOP for Footwear Cleaning in Pharmaceutical
5.4 Entry and exit in pharma (between the shifts)
To use the washroom:
5.4.1 Follow steps 5. 2.1 or 5.2.3
5.4.2 Wear washroom sleepers and enter the washroom area.
5.4.3 After using the washroom, wash your hands with soap solution and water.
5.4.4 Dry hands by using a hand dryer (use a paper napkin if required).
5.4.5 Came out from the washroom and kept the washroom sleeper at its designated place.
5.4.6 Follow steps 5.1.10 and 5.1.17 to enter the production area.
5.4.7 Follow steps 5.2.4 and 5.2.8 to exit the changing room.
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