SOP for Entry and Exit for General Area PRinj-01

SOP for Entry and Exit for General Areas of pharmaceutical plants are critical to ensure the safety, security, and compliance of the facility. These procedures are in place to protect both the employees and the products being manufactured. The specifics may vary from one pharmaceutical plant to another, but here are some general guidelines and steps that are commonly followed:

Entry Procedures:

1. Security Check: Upon arrival at the facility, all individuals, including employees, visitors, and contractors, should go through a security check. This may include identity verification, background checks, and physical inspections of bags and belongings.
2. Access Control: Entry to the plant should be restricted to authorized personnel only. Access control systems, such as badge readers or biometric scanners, are often used to ensure that only approved individuals can enter specific areas.
3. Visitor Registration: Visitors should sign in and provide identification. They may be required to wear visitor badges or badges that indicate their access level.
4. Health and Safety Screening: In some cases, especially during health crises or pandemics, individuals entering the facility may be subject to health and safety screenings, including temperature checks and health questionnaires.
5. Training and Orientation: Visitors and contractors typically receive a safety orientation and are made aware of any specific hazards or safety protocols within the facility.
6. Escort Requirements: Depending on the facility’s policies, some visitors, especially contractors or non-employees, may need to be escorted by authorized personnel at all times while inside the facility.

Exit Procedures:

1. Badge or Access Return: Visitors, contractors, and employees leaving the facility should return their access badges or passes.
2. Security Check: Similar to the entry procedure, individuals may be subject to security checks when leaving the facility to ensure they are not taking unauthorized materials or information with them.
3. Inventory Control: If employees or contractors have been handling materials, equipment, or products, there may be a need for inventory checks to ensure that nothing is missing or unaccounted for.
4. Decontamination Procedures: In some pharmaceutical plants, especially those dealing with hazardous substances, employees may be required to go through decontamination procedures before leaving certain areas or the entire facility.
5. Documentation: Some facilities may require employees and visitors to complete specific documentation or sign out when leaving, which could include confirming that safety procedures were followed and materials were returned.
6. Exit Interviews: In some cases, exit interviews may be conducted to gather feedback and ensure that all exit procedures were followed correctly.
7. Confidentiality and Security: Employees and visitors are typically reminded of the importance of confidentiality and security when leaving the facility, and they may be required to sign nondisclosure agreements

SOP for Entry and Exit for General Area of the Pharmaceutical Plant

• OBJECTIVE:
  • To lay down a procedure for entry and exit in general area of production department.
• SCOPE:
  • This SOP is applicable to all personnel entering in to the General Area of Production Department.
• RESPONSIBILITY:
  • All the personnel entering and leaving the General area i.e. CNC corridor, IPQA, Labeling area and automatic visual inspection area, Pre-Sterilization area, Vial collection area, Production office, Un-control area, Rejected semi-finished goods area, Primary packing material day store, Semi-finished goods quarantine area, Manufacturing change room, Change room I (wash area), Empty ampoule/Vial staging area, Raw material staging area, Linen distribution room, Exit and receiving airlock of Vial/Ampoule, Incubator room of production department.
• ACCOUNTABILITY:
  • Head of department/ designee shall be accountable for proper implementation of the SOP.
• DEFINITIONS:
  • Nil.
• PROCEDURE:
• Precautions:
  • Do not carry any personal belongings (Tiffin’s, wallet, bags, jewellery, camera etc.) inside the area.

• Entry Procedure for production general area (Staff):
  • Scan your appropriate finger over the biometric system and enter in to the main corridor by pushing the door.
  • Remove the foot wear and keep in rack provided in main corridor.
  • Collect the wash room foot wear from rack provided and enter in to the male washroom.
  • Wash the palm with water and soap solution.
  • Wash the fingers with water and soap solution.
  • Wash the thumb with water and soap solution.
  • Wash the hands up to elbow with water and soap solution.
  • Dry the wet hands up to elbow with tissue paper provided in wash room.
  • Again dry the hands up to elbow with hand dryer for complete drying of water.
  • Remove the wash room foot wear and keep in rack provided in main corridor.
  • Collect the factory foot wear from rack provided and wear.
  • Press the interlock button and when indications GO appears open the door and enter in to the change room 1.
  • Remove your 2nd footwear, street garments sequentially and keep inside the respective garment cabinet provided in the change room 1.
  • Place your both feet on the tacky mat provided at the entrance of the change room 2.
  • Press the interlock button and when indications GO appears open the door and enter in to the change room 2.
  • Sanitize the hands up to elbow with 70% IPA/Sterilium provided in male change room 2.
  • Dress code shall be as per SOP no. SOP/XXXYYY.
  • Take the cleaned garment set of appropriate (cap, trouser and shirt) from the pass box.

• Follow the gowning procedure sequentially:
  • Wear the cap and ensure all hairs are well tucked in the cap.
  • Wear the shirt and trousers appropriately. Tuck the shirt into trousers.
  • Take out the cleaned shoes from the cabinet and wear it.
  • Stand in front of the mirror and check the adequacy of attire.
  • Press the interlock button and when the GO indication appears open the door and Enter the buffer room.
  • Place both your feet on the tacky mat provided at the entrance of the buffer change room.
  • Sanitize the hands under the automatic hand sanitizer provided in the buffer room.
  • Press the interlock button and when GO indication appears open the door and Enter the CNC area.
  • Follow the procedure for Entry as per photographs present in the change room.
• Exit Procedure from production general area (Staff):
  • Press the interlock button and when GO indication appears open the door and Enter in to the buffer room.
  • Sanitize the hand under automatic hand sanitizer.
  • Press the interlock button and when GO indication appears open the door and Enter in to the change room 2.
  • Open the SS cupboard provided in change room 2 and keep shoes, cap, trouser and shirt in SS storage cupboard provided in change room 2.
  • On every third day, at the end of the shift take freshly cleaned garment set (cap, trousers, and shirt) from the pass box as per their size for the next day and keep it in the provided cabinet in the change room 2.
• NOTE: On every third day, at the end of the shift remove the garments in change room 1                    and dispose it in used garment bin.
  • Press the interlock button and when indications GO appears open the door and enter in to the Change Room 1.
  • Take street cloth and factory footwear kept inside the cabinet assigned to individual and wear it.
  • Pick the used garment from the used garment bin.
  • Press the interlock button and when indications GO appears open the door and enter into the main corridor.
  • Dispose the used garment in the used garment cabinet provided in the main corridor on every third day for washing. 
  • Press the interlock button and when indications GO appears open the door to exit from corridor and enter into the reception area.
  • Follow the procedure for exit as per photographs present in the changing room.
• Entry Procedure for production general area (VISITOR’S):
  • Visitor shall be accomplished by any authorized person. Scan the finger over the biometric system provided in Reception area and enter in to the main change room main corridor by pushing the door.
  • Press the door and enter into Visitor wash room.
  • Wash the hands as per the procedure mentioned in the Appendix.
  • Press the interlock button and when the indications GO appears open the door with elbow.
  • Place both your feet on the tacky mat provided at the entrance of change room 1.
  • Take nose mask from nose mask box and wear it.
  • Wear the disposable shoe cover from the shoe cover dispenser/locker.
  • Press the interlock button and when the indications GO appears open the door with elbow and enter into change room 2 and sanitize the hands up to elbow with 70% IPA/Sterilium provided.
  • Open the SS cupboard provided in change room 2 and take out the disposable gown from the cabinet.
  • Follow the gowning procedure sequentially.
  • Wear the cap (ensure all hairs are well tucked in the cap).
  • Wear the shirt and trousers appropriately. Tuck in the shirt into trouser.
  • Stand in front of the mirror and check for appropriateness of attire.
  • Press the interlock button and when indications GO appears open the door with elbow.
  • Sanitize the hands with disinfectant under automatic hand sanitizer provided in buffer room.
  • Press the interlock button and when indications GO appears open the door by pull the door with wrist and Enter into the CNC corridor.
  • Follow the procedure for Entry (VISITOR’S) as per photographs present in the change room.
• Exit Procedure from production general area (VISITOR’S):
  • Visitor shall be accomplished by any authorized person. Scan your appropriate finger over the biometric system provided in CNC corridor and Enter in to the buffer room by push the door with elbow.
  • Press the door interlock button and when indications GO appears open the door with wrist and Enter in to the change room 2.
  • Firstly remove the trouser followed by gown and cap dispose in disposal bin provided in pass box.
  • Press the interlock button and when indications GO appears pull the door with wrist and open the door to enter in to the Change Room 1.
  • Remove shoe cover followed by nose mask and cap (if disposable cap used) and both are dispose in disposal bin provided in change room-1.
  • Press the interlock button and when indication GO appears pull the door with wrist and open the door enter into the main change room main corridor.
  • Press the interlock button and when indications GO appears pull the door with wrist and open the door to exit from corridor and enter into the reception area.
  • Follow the procedure for Exit (VISITOR’S) as per photographs present in the change room

• ABBREVIATIONS:
  • SOP         :    Standard Operating Procedure
  • CNC        :    Controlled Not Classified
  • IPA          :    Iso propyl alcohol
  • IPQC       :   In Process Quality Control
  • PR            :    Production
• REFERENCES:
  • Nil
• DISTRIBUTION LIST:
  • Control copy of SOP shall be distributed to Quality Assurance Department and Production Department.
• ANNEXURES
  • Entry procedure for General area (Staff )                                            :     SOP/PR/XXXYYY
  • Exit procedure for General area (Staff )                                              :     SOP/PR/XXXYYY
  • Entry procedure for General area (Visitor’s)                                        :     SOP/PR/XXXYYY
  • Exit procedure for General area (Visitor’s)                                          :     SOP/PR/XXXYYY