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sop for Personal Hygiene

 

sop for Personal Hygiene

 

1.0 Objective
To lay down a procedure for hygienic conditions that followed while entering into the factory premises.
2.0 Scope
This SOP is applicable to hygienic conditions that followed while entering into the factory premises.
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 Personnel clothing and hygiene are important parameters for achieving the objectives of cGMP

and preventing product contamination. Cleanliness and Protective clothing shall be used as

major tools for maintaining personnel hygiene.
5.2 Cleanliness
5.2.1 Employees shall be advised and encouraged to have regular bath, and to change their clothes daily.
5.2.2 Every time hand shall be washed with soap / disinfectant and dried using hand dryer after visiting the toilets.
5.2.3 Combing of haring shall be strictly forbidden in all areas other than change room.
5.2.4 Personnel entering in production area shall maintain proper oral hygiene by brushing their teeth daily at home.
5.2.5 Nails shall be cut properly so as to avoid any accumulation of dirt.
5.2.6 Before entering to production area personnel shall wash their hands with soap and shall dry with

the help of hand drier or like wise.
5.3 Protective Clothing
5.3.1 The purpose of protective clothing is not only for the protection of the user but also to protect

the product from cross contamination. To protect the product from contamination, ensure the following:
5.3.1.1 Outdoors clothing shall not be brought directly into the manufacturing area and personnel

entering the manufacturing area shall be clad in factory protective uniforms.
5.3.1.2 Before entering production premises all employees should removed their ornaments

(Ring, jewelry, watch etc.)
5.3.1.3 All female employees are expected to tighten their hair and do not use any kind of cosmetics

items and ornaments too on the duty.
5.3.1.4 For entering in manufacturing area personnel shall change or cover their street clothes, and

wear clean factory uniform in change room.
5.3.1.5 Masks shall be worn to cover the nostrils and mouth especially in the manufacturing,

filling, dusting, coating and sorting area.
5.3.1.6 Proper gloves / mask / booty are to be worn by the personnel handling starting materials,

primary packaging materials and intermediate or bulk products.
5.3.1.7 For entering in manufacturing factory footwear shall be worn in change room after swing over bench area.
5.4 Hygienic Behavior
5.4.1 High standards of personal hygiene and cleanliness are essential. Personnel involved in the

manufacturing shall report any condition relating to plant, personnel or equipment, which

adversely affect the product.
5.4.2 High standards of personal hygiene and cleanliness are essential. Personnel involved in the

manufacturing shall report any condition relating to plant, personnel or equipment, which adversely affect the product.
5.4.3 Any person showing at any time to have an apparent illness or open lesions that may adversely affect

the quality of products or affect the health of other employees shall not be allowed to handle raw

materials, packaging materials, inprocess materials or finished products until the condition is no longer judged to be a risk.
5.4.4 Ensure that workmen shall keep their lockers in clean and tidy condition and shall undergo

regular checks. (Unclean lockers are a big source of contamination).
5.4.5 After tea, lunch or other activity, wash hands thoroughly before returning to work place.
5.4.6 Follow the gowning procedure as per SOP.
5.4.7 Trained all the persons prior to and during practices which ensure Personnel hygiene.
5.4.8 All male / female worker and other employees shall undergo regular check by authorized persons for:
5.4.8.1 Proper hair cut
5.4.8.2 Personal cleanliness
5.4.8.3 Proper nails trimming
5.4.8.4 Oral hygiene
5.4.8.5 Clean hands
5.4.8.6 Clean dress and factory foot wear
5.4.9 The uniforms of the employees shall be washed on weekly basis
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 BATCH MANUFACTURING

sop for placebo batch

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

sop for Sanitization of Seals

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 equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

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

sop for Personal Hygiene

 

 

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