Each pharmaceutical industry has its own entry and exit procedure in the plant and manufacturing area. The pharmaceutical industry designs its entry and exit procedure in such a way to prevent contamination. Human is a major source of contamination. So, this SOP introduces how to enter and exit the pharma industry, manufacturing area, production area, what precautions are necessary while entering the departments, entry and exit procedure for all employees, workers, visitors. The main goal of the entry and exit procedure to avoid cross-contamination.

SOP for Entry and Exit Procedure in the pharma industry and Manufacturing Area of all employee/workers/visitors

1.0 PURPOSE:  

To provide a procedure for entry and exit for all employee, workers, visitors, outsiders

2.0 SCOPE:

Applicable to all employees, workers, visitors, outsiders.  

3.0 RESPONSIBILITY:  

All staff, workers, and visitors (office staff, consultants, vendors, auditors, etc)  

4.0 DEFINITION:

Not Applicable  

5.0 PROCEDURE:  

5.1 All employees entering in plant and manufacturing area should follow the entry-exit procedure.

5.2 Separate change rooms should be available for males and females. (Male change Room and Female Change Room)

5.3 Updated pictogram should be available on display board showing entry and exit procedures follow in the change rooms.

5.4 Pictogram should be approved by Quality Assurance Head to ensure that the procedure mentioned in the SOP is correctly represented on the display board.

5.5 All gown using in the manufacturing area should be lint-free cloth.

5.6 Entry Procedure for staff and workers in plant/factory and manufacturing area:

5.6.1 Enter the campus with a Punch Card/ Identity Card.

5.6.2 Security person checks each employee for any unwanted things i.e. cigarette, tobacco, chewable gum, etc. Check the bag of each employee before entering the plant.

5.6.3 An unauthorized employee should submit the mobile phone at the security cabin.

5.6.4 All employee entering the plant should place the Lunch box and other belongings in the Tiffin Box Room at a designated place.

5.6.5 Keep a clean finger on the provided place of the fingerprint reader for the attendance and record of employee presence.

5.6.6 Enter into the street shoes change room and employee should remove street shoes and put it in the locker.

5.6.7 Wear shoe cover over the naked feet and move out of the street shoe change room.

5.6.8 Enter the change room and remove the shoe cover and put it into the bin.

5.6.9 Remove your personal ornaments e.g. wristwatch, jewelry, ring, bindi and keep in the locker.

5.6.10 Collect clean cloths (cap, apron, trouser) and safety shoes/slipper (for new employee only) from the housekeeping department as per the department color code and your body size.

Sr. No.	Department	Color code
1	Store	Faint pink
2	Production	Faint blue (sky blue)
3	Quality Assurance and Quality Control	White
4	Engineering/Technical	Dark blue
5	Workers of all department	Brown

5.6.11 Wear the cap in such a way that it completely covering the head, hair, and ear too.

5.6.12 Remove and fold the street clothes and place them into the locker. Wear an apron and trousers.

5.6.13 Locker having two part upper for the cloths and lower for the factory shoes.

5.6.14 Employees already having issued factory shoes collect their factory shoes from the locker. Take it with you near to cross over the bench.

5.6.15 Sit on a cross over bench and wear factory shoes such that feet do not touch the surface of the floor towards the entry of the manufacturing area.

5.6.16 Collect a beard mask from the left side of the cross-over bench drawer and wear it in such a way that your mustache and beard completely covered. (Beard mask is not applicable for the person who has a clean shave and without a mustache).

5.6.17 Swing yourself on the cross over bench toward the entry area of the manufacturing corridor.

5.6.18 Stand up and place your hands below the auto hand sanitizer sensor having near about distance 1.5 to 2 cm. The sensor senses the hand and sprays the 70% IPA on your hand. Use manual disinfectant system in case of the auto hand sanitizer system is not working.

5.6.19 Rub your hand and fingers with 70% IPA on the front side and the backside.

5.6.20 Check yourself in front of the mirror for a proper gowning procedure.

5.6.21 Enter into manufacturing corridor and go to the respective department.

5.7 Exit Procedure for staff and workers in the plant/factory and manufacturing area:

5.7.1 At the time of lunch/ dinner/ any break/ shift change, come out of the respective area/ department.

5.7.2 Enter into the male/female change room.

5.7.3 Disinfect both the hands with disinfectant solution (Use manual disinfectant system in case the auto system is not working).

5.7.4 Then enter the next room by opening the door.

5.7.5 Sit on a cross over bench and swing yourself towards the locker area.

5.7.6 Remove the factory shoes and keep them aside for a while.

5.7.7 If there is a case of a break (lunch, dinner, etc.) then directly go in front of locker, remove your factory cloths completely, start from the apron, trouser and keep the factory garment in the nice folding condition in a locker.

5.7.8 If there is a case of shift change then remove your factory cloths completely, start from the apron, trouser and put it into the “Used Garment” labeled bin.

5.7.9 Remove the cap and put it into the “Used Cap” labeled bin.

5.7.10 Remove your beard masks and put them into the “Used mask” labeled bin.

5.7.11 Wear your factory shoes and after point no. 5.7.7 and 5.7.10. Collect your street clothes, wallet, and ornaments (jewelry, wristwatch, etc.) from your locker and wear them.

5.7.12 Collect and wear shoe cover and exit from the change room.

5.7.13 Open the door of street shoes locker room and remove shoe cover into labeled “Used Shoe cover” bin.

5.7.14 Collect the street shoes from the locker, wear it.

5.7.15 Exit the street shoes locker room.

5.8 Entry procedure for Visitors/Outsider (Auditor, vendors, etc.) and Office staff (all employee working in outside the manufacturing area):

5.8.1 Visitors /Outsiders first admit their presence on the security gate.

5.8.2 Security person with talk with the employee who wants to meet visitor (if required).

5.8.3 In case of auditor security person should inform the Admin department immediately.

5.8.4 Visitor should write his/her name, address, purpose, contact number, name of contact person (employee in the plant) in security register with sign and date.

5.8.5 Security person issue the gate pass having detailed about visitors name, contact number, address, purpose, name of the contact person by referring to the register.

5.8.6 Collect the gate pass from the security person.

5.8.7 Security person checks each employee for any unwanted things i.e. cigarette, tobacco, chewable gum, etc. Check the bag of each employee before entering the plant.

5.8.8 All visitors entering the plant should place the Lunch box in the Tiffin Box Room at a designated place.

5.8.9 Only necessary belonging (toolbox, documents, etc. of vendors) is permitted to keep with visitors other belongings keep in the Tiffin box room.

5.8.10 For admin person should follow the plant entry procedure as per the point number 5.6.1 and 5.6.5.

5.8.11 Enter into the visitors change room.

5.8.12 Remove personal belongings (wristwatch, jewelry, sticker bindi) and keep in the locker provided in the change room for visitors.

5.8.13 Disinfect both the hands with disinfectant solution (Use manual disinfectant a system in case the auto system is not working).

5.8.14 Take clean disposable cap from the ‘Clean Cap’ section provided and wear as so that hair is covered.

5.8.15 Take a Gray-colored visitor’s apron from the cupboard. On the apron, the pocket side printed as “Visitors” to identify the apron. Wear apron.

5.8.16 Sit on the cross over a bench. Collect beard mask and shoe cover from the left side of the cross over bench drawer.

5.8.17 Wear a beard mask in such a way that your mustache and beard completely covered. (Beard mask is not applicable for the person who has a clean shave and without a mustache).

5.8.18 Wear the shoe cover and swing yourself toward the entry manufacturing area.

5.8.19 Disinfect both the hands with disinfectant solution (Use manual disinfectant the system in case the auto system is not working).

5.8.20 Check yourself in front of the mirror for a proper gowning procedure.

5.8.21 Enter the corridor and visit the concerned department.

5.9 Exit procedure for Visitors/Outsider (Auditor, vendors etc.) and Office staff (all employee working outside the manufacturing area):

5.9.1 After completion of the work contact person should sign on the visitors gate pass.

5.9.2 After signing on the visitors gate pass person should enter the visitors change room. Office staff not required visitors gate pass.

5.9.3 Disinfect both the hands with disinfectant solution (Use manual disinfectant the system in case the auto system is not working).

5.9.4 Sit on a cross over bench swing yourself towards the locker area.

5.9.5 Remove your shoe cover and beard mask and put it into the “Used Cap” labeled bin.

5.9.6 Remove the apron and put it into the ‘Used Garment’ bin.

5.9.7 Disinfect both the hands with disinfectant solution (Use manual disinfectant the system in case the auto system is not working).

5.9.8 Collect personal belongings.

5.9.9 Exit the change room.

6.0 ABBREVIATIONS:

SOP – Standard Operating Procedure

7.0 REFERENCES:

7.1 21CFR –Subpart B: Section § 211.28

7.2 Eudralex Volume-4, Chapter2 – Personnel (Personnel Hygiene) and Annex I – Personnel

7.3 Schedule-M, Part 1, Subpart 4.1

8.0 HISTORY

Not Applicable

9.0 ANNEXURES

Not Applicable

FAQ: