SOP for Entry and Exit Procedure in Pharmaceuticals 

1.0  OBJECTIVE:

 The purpose of this SOP is to lay down the procedure for entry and exit for the Pharmaceuticals Company

2.0  SCOPE:

This standard operating procedure is applicable for the Entry and Exit of the QC/PD/WH department of Pharmahub Ltd Unit-I, Roorkee.

3.0 RESPONSIBILITY:

  All Employees, Workmen, Visitors, and Auditors enter to the Pharmaceuticals Company.

4.0     ACCOUNTABILITY:

Plant- Head

QA- Head

Head/ Manager of respective department (QC/PD/WH)

5.0      PROCEDURE:

5.1       Entry procedure:

5.1.1    After biometric punching, QC/PD/WH personnel shall enter the change room of the respective department (QC/PD/WH ) department.

5.1.2 Eating and chewing of gutka, pan masala, or drinking of beverages, etc are prohibited in pharmaceuticals premises.

5.1.3 Shave your beard & trimmed the mail and hair on a regular basis.

5.1.4 No medicines are allowed to be kept inside the change room lockers or any other places except prescribed medicine.

5.1.5    Scrub their footwear on a foot mat just laying in front of production/QC department/Warehouse etc.

5.1.6    Open the door and enter the primary change room & follow the pictorial sequence of entry and exit steps.

5.1.7    Remove street footwear and place them in the shoe racks.

5.1.8    Put the personal belonging like wallets, purses, ornaments wristwatches, etc. in the personal locker which is               allotted to each individual

5.1.9   Wear the company footwear and overgrow the apron after crossing the cross-over bench.

5.1.10  Check the full attire for proper dress up in front of the mirror.

5.1.11  Enter into respective area pharmaceuticals area like QC/PD/WH after sanitizing their hands with disinfectant

5.1.12  Open the door and move to the respective dept. like QC/PD/WH.

5.2       Entry procedure for visitors in pharmaceuticals:

 5.2.1    Enter the change room and wear shoe covers over the street footwear and overgrow the disposal apron.

5.2.2    To cross the cross-over bench,

5.2.3   Enter in pharmaceutical departments like QC, PD, WH, etc.

5.2.4   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 the respective place.

5.3    Exit Procedure:

5.3.1  To exit personnel shall return back from their respective department to the change room.

5.3.2  Open the door and enter the changing room. Remove the apron and factory shoes and keep them in the designated place for further use (after lunch/dinner/tea break or any other reason) if the shift is not over.

5.3.2  If shift is over, used gowns shall be dropped into the used gown bin, and housekeeping personnel shall collect them in a plastic bag and send them for washing with the label “TO BE CLEANED”.

5.3.3  Cross over the bench, collect, and wear personal footwear.

5.3.4 Open the door and move out of the change room.

6.0  ATTACHMENTS/ ANNEXURES

NIL

7.0  REFERENCES

NA

8.0  ABBREVIATIONS

SOP: Standard operating procedure

WH: Warehouse

QA:  Quality Assurance

QC:  Quality Control

9.0 DISTRIBUTION

Master copy: QA

Control Copy: WH/QC/PD etc.

10.0  REVISION SUMMARY

Supersedes	Effective Date	Reason for Review	Remark
00	04/09/2020	New SOP	Change control no. XYX

 

FQA- Entry and Exit procedure:

1. What is Standard Operating Procedure (SOP) for entry and exit in 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.

2. What is entry and exit procedure in Pharma?

Biometrically punching or manually entry shall be done in attendance register. After that scrubbing of footwear shall be done on a foot mat. Follow the pictorial sequence of entry and exit steps. Put personal items in the personal locker that is assigned to each person, such as wallets, handbags, jewellery, wrist watches, etc. 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.