ENTRY OF PERSONNEL INTO OPERATIONAL AREAS AND THEIR HYGIENE sop

STANDARD OPERATING PROCEDURE

SUBJECT :                                             ENTRY OF PERSONNEL INTO OPERATIONAL AREAS AND THEIR HYGIENE

DEPARTMENT           : GENERAL SOP NO.                      : xxx Page No                       : 1 of  3 Effective Date             : 31.07.2015 Next Review                : 30.07.2017 SOP REVISION           xxx

                                                           

1.0       OBJECTIVE:

To avoid external dust and cross contamination and to keep the area neat and clean.

2.0       POLICY:

To ensure that all personnel entering operational areas follow basic principles of hygiene and cGMP.

3.0       PROCEDURE:

3.1       WORK MEN ENTRY

3.1.1    All personnel entering the factory premises will first punch the manual attendance card and then the finger print computerized attendance record and proceed to the change room.

3.1.2    They will then deposit their street shoes & personal belongings and street clothes in the cupboard provided.

3.1.3    They should then proceed into the next room and wear the company Uniform, put on the headgear and ensure that all hair is covered by the headgear.

Color code of Uniform:

1. White Apron: Staff and Visitor.

2. Light blue Shirt & Pant: Work force and Operators.

3. Dark Blue Shirt and Pant: Engineering Staff.

4. Yellow Shirt and Pant: House Keeping Staff (Gents only)

5. Dark Brown Apron: House Keeping Staff (Ladies only)

3.1.4    All personnel shall wear the footwear provided to them.

	PRIME MOVER                             CONCURRER                                                  APPROVER EXECUTIVE (Q.A)                 PRODUCTION MANAGER                                        G.M (Q.A)

                                                                                                                       

SOP No.          :xxx

                                                                                                                                    Page                : 2 of 3

                                                                                                                                    Revision No    xx

3.1.5    After changing they should rinse their hands with disinfectant solution and then proceed to the Manufacturing / Packing areas after punching the attendance card.

3.1.6    All personnel shall wash and dry their hands and rinse their hands with disinfectant solution after they go for toilets.

3.1.7    All personnel shall change back to street clothes while going out of premises and during breaks. For every re-entry, the entry procedure is to be followed.

3.1.8    All personnel will ensure that their nails are cut short and cleaned regularly. All gents should regularly shave and have short hair.

3.2        STAFF AND VISITORS ENTRY

3.2.1    Aprons, gloves, masks and headgears/caps etc are provided separately for staff and visitors. Shoe covers for Visitors are provided to see that dust from shoes does not enter production areas. Staff & visitors need to follow the displayed gowning procedure before entering into operational areas.

3.2.2   All persons suffering from communicable diseases / skin diseases and any open wounds are not    

           allowed to enter the plant.

 3.2.3   Washed dresses are issued twice a week & often whenever necessary depending on the work area.

3.2.4    Uniforms are washed with detergent, dried and pressed. This operation is done by a contractor.

3.2.5    Eating, drinking smoking and chewing is prohibited in work premises and is allowed only in the   

            cafeteria provided with water.

3.2.6    Persons who are working in manufacturing, filling, in-processing and strip packing areas where the product is directly in contact with the persons, they should wear nose mask, hand gloves etc to protect the product and person.

3.2.7    List of personnel permitted to enter into operational area are,

            1.  Production Supervisors and production staff.

            2.  QA staff.

            3.  Manufacturing Operators.

            4.  Managers.

            5.  Directors.

            6.  Representative of principal companies.

            7.  Packing staff.

            8.  Maintenance staff.

            9. House keeping persons.

           10.  Any other personnel based on the work need and demand.

Secondary gowning Procedure :

3.3.1 All persons  entering into core areas must follow following gowning procedure

   a. Company staff   should remove the  foot wear and wear shoes ,apron ,pant, nose mask, gloves,

     and cap provided near  the entry of secondary gowning area.

   b. Visitors need wear shoe cover, mask, glovess ,pant and apron.

   c. On exit  of core area face mask ,glovess, shoe cover to be removed and placed in the  bin.

   d. Place reusable garments on the hanger provided.

   e.Shoes to be placed in the shoe rack.

   f.House keeping ladies should wear long bottom dress to cover the saree.Remove company provided slippers and wear shoes before entering the  core areas.

  

 3.3.2  Colour code of  uniforms:

    XXXX –Pink  gown and pink pant.

    XXXX – Green gown and green pant.

    XXXX– White colour uniform.

    XXXX house keeping – Pink colour long bottom dress.

    XXXX house keeping – Green colour long bottom dress.

    XXXX House keeping drees- Green colour long bottom dress.

 

4.0       FREQUENCY            : As & when required.

5.0        RESPONSIBILITY:  Dept. Executive / Executive QA.

                                                             

6.0       REVIEW GUIDE: --------

PRIME MOVER                             CONCURRER                                                  APPROVER EXECUTIVE (Q.A)                 PRODUCTION MANAGER                                        G.M (Q.A)