SOP for Entry and Exit Procedure in Manufacturing Area
1.0 Objective
To lay down guidelines of entry procedure for entry and exit procedure in Manufacturing Area.
2.0 Scope
This procedure is applicable for entry and exit procedure in Manufacturing Area in abc company.
3.0 Responsibility
3.1 All Supervisor of HR & Administration
3.2 Manager/ Head Concern Area
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
HR : Human Resource
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
HOD : Head of Department
5.0 Procedure
5.1 Procedure for Entry to Production block:
5.1.1 After coming from the security gate, Enter in to the change rooms separately.
5.1.2 To Entry in the Production Block it is necessary to follow the procedure to make Manufacturing
environment hygienic and efficient.
5.1.3 Put off the street shoes/Slipper at the entrance and kept them at the provided rack.
5.1.4 Take the factory primary dress (Upper, Lower, and Cap) from hangers, and dress up properly
and cover the hair completely with caps and take company slipper.
5.1.5 Than look in the mirror and set the dress and then use the (IPA 70%) for hand wash.
5.1.6 And now entry in to plant for specific section.
5.2 Procedure for Secondary Gowning:
5.2.1 Gowning and Personnel Entry procedure is compulsory for all personnel entering warehouse
and core area. The procedure is outlined below:
5.2.2 After the change in primary Gowning go to secondary Gowning area.
5.2.3 Take sterilized dress from almirah.
5.2.4 First wear the head gare than wear one piece dress in to foot than hand and close the zip up to neck.
5.2.5 Now remove the primary sleepers and wear the secondary bootee in to foot.
5.2.6 Than wear the hand gloves up to wrist.
5.2.7 Dress code finalize for secondary gowning area is Sky blue Dangri for workers,
White long apron for staff with full slives.
5.2.8 After completion of gowning look at the image in the mirror for proper gowning.
5.2.9 And again use the (IPA 70 %) with hand wash dispenser.
5.2.10 And make entry in corridors for production via air lock through cross over.
5.2.11 After Entering in corridor move to specific working area.
5.3 After completion of work same revert procedure shall be followed for degowning.
5.4 For any break (e.g. tea break, lunch or to use convenience) the same gowning and
degowning procedure shall be followed.
5.5 Nothing shall be carried inside the production block from the outside.
5.6 Tobacco, smoking stick or any chewable edible item not allowed in production block.
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 & 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