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