1.0 Purposes: 1.1 lay down the standard operating procedure for the entry-exit procedure in pharma.
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 entry and exit procedures in pharma.
3.2 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.
4.2 Primary linen shall be changed twice a week 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 the 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 the 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 in pharmaceutical
5.1 Entry procedure for employees:
5.1.1 To enter the change 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 belonging 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 feet mate provided before entering change room B.
5.1.5 Inter in change room B, remove the street cloth and keep it in the cupboard provided for the purpose.
5.1.6 Wear the slippers provided in change room B for the washroom area.
5.1.7 Wash hands with a soap solution and water in the washroom.
5.1.8 Dry hand 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-ups out the boiler suit and Cap from the personal locker provided in change room C.
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 whenever 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.
5.2 Exit procedure for the employees:
5.2.1 Inter the change room C through a buffer change room.
5.2.2 Remove the boiler suit, 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 change room B.
5.2.5 Inter in change room A.
5.2.6 Collect personal belonging from personal lockers.
5.2.7 Wear street footwear.
5.2.8 Open the door to exit from the change room.
5.3 Entry and exit procedure for visitors:
5.3.1 Deposit personal belonging 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 change room A.
5.3.3 Take the boiler suit, and Cap provided in change room C.
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 hand by using the disinfectant solution provided.
5.3.8 Inter in the production area.
Note:- Visitor May wear a boiler suit disposable dress over the street clothes and shall be provided with shoes 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, 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 belonging from the box in the administration area.
5.4 Entry and exit in pharma (between the shift)
to using 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 hands with soap solution and water.
5.4.4 Dry hand 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 their 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 change room.