Standard Operating Procedure for Personal Hygiene in Pharmaceuticals
1. Purpose
To provide a standard operating procedure for personal hygiene to be followed by all the employees and personnel working in the pharmaceutical manufacturing unit to reduce the possibilities of contamination of the product and prevent the spread of any potential infection in the factory premises.
2. Scope
The scope of this SOP is applicable to all the employees and personnel working in the pharmaceutical manufacturing unit at [company name].
3. Responsibility
All employee and personnel working in the factory: To follow the instruction written in the SOP.
4. Definitions
Personal hygiene: Personal hygiene is how one care about his or her body. It includes bathing, washing your hands, brushing your teeth, and more.
5. Procedure
5.1 Basic and mandatory requirement to be followed by each and every employee:
● Cleaning of teeth every day.
● Take bath every day.
● Hair should be trimmed regularly.
● Cut nails regularly.
● Wear washed inner clothes and change every day.
● Shaving of beard regularly by male.
● Using of cosmetics and wearing jewelry such as pendants, bracelets are restricted in microbiology, production and warehouse areas.
● Lockers allocated to keep the cloths and personnel belongings as well as factory clothing should be clean as per frequency defined.
● Issue fresh factory clothing every day.
● Always wear protective clothing while at work. Arrange to repair or replace any damaged cloth.
● Wear the clothing correctly. If factory clothing are spoiled while working, it shall be changed immediately.
● On completion of assigned work, remove the protective clothing while going out of the work area.
5.2 Good hobbits and mandatory to follow at workplace to prevent contamination:
● Wash hands and legs and sanitize the hands while entering into the production and warehouse area as described in the respective SOPs.
● Hands shall be washed after using canteen for food and after using to toilet.
● Do not wiped using common towel. Use hand dryer or single use paper towel.
● Personal medication restricted inside the manufacturing, packing or storage area.
● Eatable and drinkables are not allowed in the work areas.
● Do not keep food items in refrigerator where chemicals and biological materials are kept.
● Wound should not be kept open, it should be covered with bandage.
● Personnel should be avoided to enter inside the production and warehouse area to avoid contamination.
● Use handkerchief when you sneeze or cough. In case of such condition, which cannot be controlled, employee should not enter in the production or warehouse area.
● Maintain the work area, washrooms and drinking water dispensers.
5.3 Medical checkups:
● Employee must be resume his/ her duty after successful completion of pre-employment medical checkups. This also includes contract workers who work in the plant premises.
● Illness or communicable disease to the employee should be immediately to area in charge or supervisor. Production and warehouse area should not be used in such situations.
● Employee should submit fitness certificate issued by a competent physician should be verified by company’s authorized physician before rejoining duty after recovery from illness.
● 100% employee required to participate in the scheduled periodic medical check-up program (frequency established by organization).
● Report any unhygienic operation being carried out in the plant premises.
● Department head and supervisors must be attentive and observant to notice unhygienic condition in the department and plant premises.
Managing visitors to ensure health and hygiene inside the factory premises.
● To ensure the health and hygienic condition inside the plant, self-declaration of health status should declared by visitor that they are infected without any contagious diseases. If such situation is there, entry of the visitor should be restricted from entering inside the facility.
● The declaration should be verified by authorized personnel in the factory premises.
6. Frequency
● Cleaning of lockers: Weekly
● Issuance of fresh factory clothing: Daily
● Medical checkups: Pre-employment, once in year for general tests, eye checkup for visual inspectors – once in six month
7. Formats
Self-declaration for visitors:
I hereby declare that to the best of my knowledge and belief that I am suffering / not suffering from any contagious of communicable diseases.
Name of Visitor: ______________________
Sign of Visitor: ______________________
Date of declaration: ______________________
Verified by Authorized employee of the company: ______________________
