SOP for visitor’s in Pharmaceutical Industry

Entry and exit procedure for visitor’s in the Pharma industry 

1. OBJECTIVE:

To lay down the standard operating procedure for entry and exit of visitors in factory premises.

2. SCOPE:

This procedure is applicable to all the visitors visiting the factory premises of Pharmahub Ltd Unit-I, Roorkee.

3. RESPONSIBILITY:

Security Officer / Head Guard

HR department

Visitors

4. ACCOUNTABILITY:

Plant- Head

HR-Head

5. PROCEDURE:

5.1 Entry Procedure:

5.1.1 The person, who is not an employee of the company shall be treated as a visitor like an Auditor, trainee, visiting the plant, Govt. officer, VIP / International Auditor, etc.

5.1.2 Visitors are only permitted during the general shift.

5.1.3 The security officer shall identify visitors about them and shall request to follow the entry and exit procedure of the company.

5.1.4 Visitors shall make the entry in the Visitor’s tracking Register/Visitor’s Movement Register/log and shall provide the detail e.g. date, name of the visitor, address of visitor, entry and exit time, the purpose of visit, name of personnel he/she wants to meet, visitor signature and security officer signature.

5.1.5 The security officer shall prepare and provide the Visitor’s card and Visitor,s gate Pass, as per Annexure-I and Annexure -II.

5.1.6 The visitor shall carry the visitor pass and move towards reception as per the given instruction by the security officer.

5.1.7 The security officer shall inform to receptionist telephonically.

5.1.8 Instruction shall be given by the Security officer to the visitor to press the headcount button before entering the 5.1.9 factory premises.

5.1.10 The receptionist shall inform to concerned person about the visitor and fix the meeting. Visitors shall wait in the meeting room/waiting room.

5.1.11 If any visitor wants to visit the production/ Quality control /warehouse along with carrying any belongings like Laptop, camera, mobile, or any other electronic device or tools shall only be allowed after taking permission from Plant Head.

5.1.12 Visitors shall Enter the change room and wear shoe covers over the street footwear and overgrown the deposal apron.

5.1.13 Visitors shall cross the cross-over bench,

5.1.14 Visitors shall Enter in pharmaceutical departments like QC, PD, WH, etc. as per requirements.

5.1.15 Visitors shall After visiting the concerned area return back in the change room and cross the cross-over bench and discard the shoe covers in the waste bin and apron in their respective place.

5.1.16 External candidates such as short-term training/industrial training, consultants, etc. are allowed special training for a limited period. visitor pass shall not be issued to such candidates and movement shall be recorded at the security gate in the visitor register.

5.1.17 The govt. officials from departments like Excise, Income Tax, Labor Department, Director of Factories, Drug Department, etc. shall be allowed to go inside the factory premises after disclosing their identity.

5.1.18 The security officer shall inform the concerned Personnel /department about the govt. officer entrance.

5.2 VIPs / International Auditors:

5.2.1 Security officers are usually informed of VIP/international auditor visits in advance.

5.2.2 The representative of management makes all the formalities at the Security gate.

5.2.3 All formalities shall be performed by a representative of management at the security gate.

5.2.4 Vehicles of VIP visitors/national and international Auditor(s) shall be directed to the administrative area, where management representatives will meet them and escort them to the meeting place.

5.2.5 If VIP visitors/domestic and international auditors want to enter sterile (clean) areas, normal body flora shall be checked as per respective SOP.

5.3 Exit Procedure:

5.3.1 After completion of the visit, the reverse of the entry procedure shall be followed by the visitor.

5.3.2 A management representative escorts him/her back to the meeting/ conference room.

5.3.3 The visitor’s pass & visitor slip, duly signed by the person visited shall be deposited to the security officer at the security gate.

5.4 General Instructions for the Visitors:

5.4.1 The person entering in the Production Department shall have to follow the respective SOP to follow the gowning procedure related respective area.

5.4.2 The following articles are not allowed in the production area except  Plant Head permission like Cameras,

5.4.3 Transistors, Mobile Phones, any eatable or drinking items, jewelry, Bags/ Briefcase/ Suitcase, etc.

6. ATTACHMENTS/ ANNEXURES:

Annexure-I: Visitor’s card

Annexure-II: Visitor Gate Pass/Visitor Gate Pass

Annexure-II: Visitor’s tracking register/Visitor movement register

7. REFERENCES:

NA

8. ABBREVIATIONS:

SOP: Standard operating procedure

WH: Warehouse

QA:  Quality Assurance

QC:  Quality Control

9. DISTRIBUTION:

 Master copy: QA

Control Copy: HR

10. REVISION SUMMARY:

Supersedes Effective Date Reason for Review Remark
00 04/06/2023 New SOP Change control no. XYX

 

                     Annexure-I: Visitor’s card

 

          Pharmahub Ltd

                              V

         VISITOR’S CARD

     

Pharmahub Ltd Unit-I,

 Roorkee.

(UK)

                                                                      Format No –HR001.00

     

                                 Annexure-II – Visitor,s Gate Pass 

                                         VISITOR’S GATE PASS                  

                                            Pharmahub Ltd Unit-I,

                                                          Roorkee

 

      (Please return this pass while going out)               

      Date…………………….

 

 

     Name of Visitor………………………………………………………………………..

 

     Address ………………………………………………………………………………

    

     Belongings to take inside the plant………………………………………………….

 

     To meet …………………………….. Purpose……………………………………….

 

     Time in ……………………………. Time out ……………………………………..

 

 

   Sign of the Visitor          Sign of the Officer Visited    Sign of the Security officer

 

                                                                                                       Format No –HR002.00

 

Annexure-III- Visitor’s tracking Register/Visitor’s Movement register

visitor's movement register
                                                                                                                              Format No –HR003.00

FAQ

What is the procedure for employee exit from the factory premises?

First of all, biometric punching or manual entry shall be done in the employee attendance register. After scrubbing their footwear on a foot mat just lay in the front entry door of the respective department. Open the primary door and follow the pictorial sequence of entry and exit steps.Put personal belonging like wallets, purses, ornaments wristwatches, etc. in the personal locker which is allotted to each individual. Wear the company footwear and overgrow the apron after crossing the cross-over bench. Check the full attire for proper dress up in front of the mirror. Open the door and move to the respective dept. follow the reverse process to exit.

 

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