Entry and Exit of Employee, Staff and Visitors to Manufacturing Area
1.0 Objective
To lay down guidelines of entry procedure for production block and manufacturing area.
2.0 Scope
This SOP shall be applicable to all employees and visitors entering the production plant
3.0 Responsibility
3.1 All authorized personnel entering to Production plant.
3.2 Manager/ Head of Concern dept. – Check, implement and review of effective of entry procedure.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
HR : Human Resource
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
5.0 Procedure
5.1 Procedure for Entry to Production block:
5.1.1 Only authorized persons shall enter the production plant.
5.1.2 Any authorized person entering into production plant shall enter
through the specified change rooms only.
5.1.3 Male employees shall enter through Male Change Room
5.1.4 Female employees shall enter through Female Change Room
5.1.5 Visitors shall enter through Visitors change Room
5.2 Entry Procedure for Employees:
5.2.1 Before enter into the Production plant.
5.2.2 Enter into the respective change room of the production plant.
5.2.3 Remove street footwear & place them in the locker provided.
5.2.4 Person visiting the toilet shall use the slippers provided in the street shoe
lockers and return back the same after use.
5.2.5 After coming out from the toilets person shall wash the hands
5.2.6 Provided with soap solution and dry using towel.
5.2.7 Remove jewellery, watches and cosmetics and keep them in the locker provided.
5.2.8 Remove street foot ware and place them in the cross over bench provided.
5.2.9 Sit on the cross over bench & cross (swing) completely to the other side.
5.2.10 Wear the slippers which provided By the company (Back for Staff and blue for workers)
5.2.11 Pick up the primary uniform – cap, long apron, for who is working in secondary packing area.
5.2.12 Pick up the Secondary uniform– Over gowning for who is working in Primary
packing area (i.e. Manufacturing Area).
5.2.13 Ensure the uniform is wearing, is neat and clean properly.
5.2.14 Ensure proper wearing by seeing in the mirror.
5.2.15 Pick up primary footwear from the locker and wear.
5.2.16 Enter into main corridor.
5.2.17 Disinfect hands with disinfectant solution provided before entering production area
5.3 Procedure for Exit to Production block
5.3.1 Enter the respective change room.
5.3.2 Remove foot wear, primary/secondary uniform – Apron/cap and gowning hang on the provided hangers.
5.3.3 Cross the step over bench.
5.3.4 Pick up the street footwear from the designated locker and wear.
5.3.5 Leave the Production plant.
NOTE: Weekly give the primary dress for washing by placing in the bin labeled as “Dress for Washing”.
5.4 Entry Procedure for Visitors
5.4.1 Visitors shall enter through Visitors Change Room
5.4.2 Pick up the shoe covers provided
5.4.3 Sit on the cross over bench keeping both the legs towards entry side.
5.4.4 Wear shoe cover on one foot and put the foot down towards the entry side of the production
plant, similarly follow the same for other foot.
5.4.5 Pick up clean apron from the cupboard and wear.
5.4.6 Wear the cap provided.
5.4.7 Ensure proper wearing by seeing in the mirror.
5.4.8 Enter into staff corridor.
5.4.9 Disinfect hands with disinfectant solution provided and enter clean area.
5.5 Exit Procedure for Visitors:
5.5.1 Enter into the change room.
5.5.2 Crossover towards entry side of the change room.
5.5.3 Remove shoe cover and cap, place them in the dustbin.
5.5.4 Remove the apron and place it in the bin labeled “Linen for Washing”.
5.5.5 Exit from the production plant.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Personnel and Administration, Production
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area
Cleaning And Assembly Of Tube Filling Machine
Proper Handling of Non Recoverable Residues
sop for Handling Of Off Line Packing
Air Washing Of Collapsible Tube
sop for Pest and Rodent Control
Cleaning of Uniforms (Factory cloths)
sop for General Instruction For Employees
Key Deposition and Issuing Procedure
sop for Cleaning and Sanitization of Drains Point
SOP for Cleaning of Change Rooms
SOP for Entry and Exit Procedure in Manufacturing Area
Entry and Exit of Employee, Staff and Visitors to Manufacturing Area