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ENTRY AND EXIT PROCEDURE IN PHARMACEUTICAL INDUSTRY

  • OBJECTIVE:

To lay down a procedure for entry and exit procedure in pharmaceutical company.

  • SCOPE:

This SOP is applicable for entry and exit procedure at {Company Name} {Company Location}.

  • RESPONSIBILITY:
  • Security officer/guard shall be responsible to follow the instruction as per lay down procedure.
  • HR Manager shall be responsible for Review, technical correction, training & monitoring of SOP.
  • ACCOUNTABILITY:

QA Manager shall be accountable for Approval & Implementation of SOP.

  • PROCEDURE:
  • FOR COMPANY EMPLOYEES:
  • All employees shall be allowed to enter/exit through the security main gate at scheduled company timing in the company premises for attendance purpose.
  • Frisked physically by the security staff of all employees during entry/exit from the company premises.
  • All staff including female employee worker frisking will be carried out by a female security staff thereafter shall mark their attendance in the attendance register / Biometric machines provided at respective locations.
  • Security officers/guard shall ensure that no one carry any objectionable article inside or outside from the company premises.
  • Only authorized persons shall be allowed to bring their mobile phone inside the company premises.
  • Outside movement of all employees between working hours, shall be maintain in staff movement register as per Annexure-II followed by duly signed Employee gate pass as per Annexure-I.
  • If any employee comes late, prior information shall be given to HR department by their concerned department Manager to allow him/her to enter in the company premises.
  • All employees shall have to follow the safety rules/traffic rules as displayed at security main gate.
  • Vehicle shall be parked at their respective place in the parking area only.
  • General instruction shall be displayed at security main gate and shall be updated time to time for general awareness for all employed persons and visitors by HR Department.
  • FOR VISITORS:
  • Visitors shall be allowed to entry/exit the company premises in company working hours only.
  • At the time of entry of visitors at security main gate, Security officer/guard shall enquire about his/her health (whether he/she is suffering from any contagious/infectious disease). It will be the responsibility of the visitor (s) to inform the staff about his /her correct status of health.
  • Visitors shall mark their entry in the respective visitor register as per Annexure-IV.
  • Security officers/guard shall ensure that visitors shall not carry any objectionable article inside or outside from the company premises.
  • Visitors shall bring any electronic item i.e. camera, laptop, or any electronic devices after approval from senior management only.
  • At the arrival of inspection authority/auditors, important visitors or VIP’s at the security main gate, HR officer/executive shall inquire to inspection authority/auditors, VIP’s about their health (whether he/she is suffering from any contagious/infectious disease) & It will be the responsibility of inspection authority/auditors, and VIP’s to inform the staff about his /her correct status of health.
  • Entries of inspection authority/auditors, important visitors or VIP’s shall be mark by HR officer/executive in the respective visitor register as per Annexure-IV.
  • Security officer/guard shall make his/her visitor slip as per Annexure-III and provide a visitor card during entry at company premises.
  • Visitors have to wear the visitor card properly.
  • Visitors shall be allowed to enter the manufacturing or unauthorized area accompanied by any authorized person of the company.
  • If required, the management representative shall accompany the visitor for further discussion in the conference room.
  • After completion of visit, the visitor shall have to deposit the visitor card & visitor slip duly signed by visited person at security main gate.
  • Visitor’s self-declaration shall be performed as per Annexure-V.

NOTE: – Any person suffering from any contagious/infectious disease shall not be allowed to enter in    GMP area.

NOTE:- Tobacco, smoking shall not be allowed to enter in GMP area.

  • REFERENCES:

Not Applicable

  • ANNEXURES:
ANNEXURE No.TITLE OF ANNEXURE
Annexure-IEmployee gate pass
Annexure-IIStaff movement register
Annexure-IIIVisitor slip
Annexure-IVVisitor register
Annexure-VVisitor’s self-declaration form
ENCLOSURES: SOP Training Record.
  • DISTRIBUTION:
Controlled Copy No. 01:Manager Quality Assurance
Controlled Copy No. 02:Manager Human Resource
Controlled Copy No. 03:Security Gate
Master Copy:Quality Assurance Department
  • ABBREVIATIONS:
No.:Number  
Dept.       :Department
Ltd.:Limited
QA:Quality Assurance
SOP:Standard Operating Procedure
VIP:Very Important Person
  • REVISION HISTORY:

                          CHANGE HISTORY LOG

Revision No.Details of ChangesReason for ChangeEffective Date
00New SOPNot ApplicableTo be written manual

ANNEXURE-I
GATE PASS

                        ANNEXURE-II

STAFF MOVEMENT REGISTER

ANNEXURE-III

                        VISITOR’S SLIP

ANNEXURE-IV

VISITOR REGISTER

ANNEXURE-V

VISITOR’s SELF DECLARATION FORM

  • Q : Who is responsible for frisking employees during entry and exit?
    • Ans: Security staff are responsible for frisking employees during entry and exit.
  • Q: Where do employees mark their attendance?
    • Ans: Employees mark their attendance in the attendance register / Biometric machines provided at respective locations.
  • Q: What are the restrictions on bringing personal belongings into the company?
    • Ans: Only authorized persons are allowed to bring their mobile phones inside the company premises.
  • Q: What is the procedure for employees who need to leave the premises during working hours?
    • Ans: Employees who need to leave the premises during working hours must maintain a record in the staff movement register and obtain an employee gate pass.
  • Q: Where should employees park their vehicles?
    • Ans: Vehicles must be parked at their respective places in the parking area.
  • Q: Who is responsible for updating general instructions for employees and visitors?
    • Ans: The HR department is responsible for updating general instructions for employees and visitors.
  • Q: What are the restrictions on visitors bringing electronic items into the company?
    • Ans: Visitors are not allowed to bring any electronic items into the company premises without approval from senior management.
  • Q: What is the procedure for important visitors or VIPs?
    • Ans: The HR officer/executive will inquire about the health of important visitors or VIPs and make entries in the visitor register.
  • Q: What must visitors do with their visitor card and slip after their visit?
    • Ans: Visitors must deposit their visitor card and slip duly signed by the visited person at the security main gate after their visit.
  • Q: What happens if someone is suffering from a contagious disease?
    • Ans: Anyone suffering from a contagious/infectious disease will not be allowed to enter the GMP area.
  • Q: Is smoking allowed in the GMP area?
    • Ans: Smoking is not allowed in the GMP area.
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