Personnel Hygiene

1.0         Purpose

1.1        Describe the procedure for the maintaining personal hygiene in the Factory premises.

2.0        Scope

2.1       This SOP is applicable to all employees and visitors who enter inside the factory of “Name” Pharmaceuticals

Ltd. 

3.0      Responsibility

3.1          Head of Plant Admin are responsible to monitoring and execution of this SOP.

3.2      All personnel working or visiting the manufacturing area are responsible for adhering to the procedures described in this document.

4.0      Abbreviations and Definitions

4.1        Hygiene: Hygiene is a series of practices performed to preserve health.

            According to the World Health Organization,

            "Hygiene refers to conditions and practices that help to maintain health and prevent the spread of             diseases.” 

4.2        Personal Hygiene: Personal hygiene is defined as the principle of maintaining cleanliness and grooming of the external body. According to the World Health Organization,

             “Personal hygiene refers to maintaining the body's cleanliness.”

 

5.0      Materials and Equipment

 

5.1        None

 

6.0      Precaution / Health and Safety Considerations

6.1        You should wear a face mask if you cannot maintain a physical distance (where you can’t  be at least 1 meter from others). 

6.2      You should always clean your hands before and after using a mask, and before touching it while wearing it.

 

7.0       Procedure

7.1          Ensure all Employees working in the Department have undergone the Medical examination and are declared

medically fit.

7.2          All Employees should have properly cut nails and hair.

7.3          Employees should follow the SOP for entry to Production area and wear Uniforms, Caps, and footwear before

entering internal corridor.

7.4          All Employees should wash and disinfect hands before entering into the production corridor.

7.5          All Employees should wear clean uniforms.

7.6          Any staff having illness, wound etc. should inform the concerned supervisor and get delegated to an area not

involving any contact with products, till healed or recovered.

7.7          All Employees should wear the Overgrown, footwear, cap, mask and gloves before entering the production

area where Products are exposed to contact.

7.8          The entry procedure should be followed for each re-entry to Production area.

7.9          Hands should be washed thoroughly with soap and dried using Hand drier / towel after every Toilet use.

7.10    Smoking, eating drinking, chewing gum etc.  should not  be done in Manufacturing area, storage area,

Laboratory, etc. and should be done only in the Canteen.

7.11        Do not use Jewelry like rings, bangles etc. in the Production areas.

 

8.0      Reference Document 

8.1        WHO GMP Guideline trs-986, annex-2

8.2        In-house

 

9.0       Annexure                     

9.1        None

 

10.0    Revision History

 

Revision No.	Brief reason for the revision	Effective Date	Remarks
01	New

 

 

11.0     Training 

11.1       Head of Quality Assurance or his nominee give the training of all employee.