SOP For Men and Material Movement

1. OBJECTIVE:

The purpose of this SOP is to lay down the procedure for men and material movement.

2. SCOPE: 

This SOP is applicable for material movement across the different blocks and area and men movement in miscellaneous areas at the manufacturing facility.

3. RESPONSIBILITY:
   1. Each individual entering into the area shall be responsible to follow the practice. 
   2. Head – Quality Assurance shall be responsible foreffective implementation of SOP.
4. PROCEDURE:
   1. Men/Material Movement in production /Packaging Area (A and B Block):
      1. The material shall be transferred to the warehouse through respective lift after the receipt of material and the dispensed/in-process material shall be transferred to respective manufacturing/packaging floor through respective lift.
      2. Material transferring to Pellets coating section (Ground floor A block) shall be transferred through “Material airlock”. Material transfer container shall be wiped off with moist duster prior to transfer in the material air lock.
      3. Man movement in “Pellets coating section” (Ground floor A Block) shall be through secondary change room after appropriate gowning specified in the SOP .
      4. Material shall be transferred to the manufacturing block (First Floor A Block) section though “Material transfer container shall be wiped off with moist duster prior to transfer in the material air lock. 
      5. Man movement in Manufacturing block (First Floor A Block) shall be through secondary change room after appropriate gowning specified in the SOP .
      6. Material shall be transferred to Granulation-II or capsule area (Fift floor ,A Block) through pass box and from in-process material store to granulation area through airlock. Material transfer container shall be clean with moist duster prior to transfer in the respective air lock where pass box is available to transfer of material.
      7. Man movement in “Granulation –II or Capsule area (Fifth floor ,A block )” shall be through secondary change room after appropriate gowning specified in the SOP .
      8. Primary Packaging Materials/Tablet/Capsule/change parts shall be transferred to respective packaging cubicle(B Block ,first floor) through respective airlock. Material transfer container shall be wiped off with moist duster prior to transfer in the respective air lock.
      9. It shall be ensured during transferring the material into respective packing cubicle that material transfer  container shall not cross the demarcation line provided in the airlock, The respective personnel inside the cubicles shall collect the material to be transferred in the cubicles in to other material transfer container/pellet from inner side of cubicle shall not cross the demarcation line during collection of material.
      10. Man movement in primary packaging cubicles (B Block ,first floor)” shall be through secondary change room after appropriate gowning specified in the SOP.
      11. Material transferring to sampling area/dispensing area/Solvent sampling and dispensing area (Third Floor A block) shall be transferred through material airlock/passbox. Cotainers shall be wiped off with moist duster prior to transfer in the material air lock/pass box.
      12. Man movement in sampling area/dispensing area/Solvent sampling and dispensing area (Third Floor A Block) shall be through secondary change room after appropriate gowning specified in the SOP (PA020).
      13. Primary Packaging Materials shall be transferred to respective sampling room (B Block , Ground Floor) in closed containers/material movement trolleys.Material transfer container/trolleys shall be wiped off with moist duster prior to transfer in the sampling room.
      14. Personnel shall enter into packaging material sampling area (B Block,Ground floor)” after appropriate gowning specified in trhe SOP(PA020).
      15. Provided demarcation line shall be crossed only after the wiping of the containers and appropriate gowning.
      16. It shall be ensure that opposite door of the airlock is closed while transferring the material.
      17. Change parts.spare shall be transferred into close container and via lift to respective manufacturing/packing area.
   2. Men Movement in miscellaneous area (A and B Block):  
      1. Visitor shall wear additional shoe cover and remove the gown/cap in the (fifth floor) at the time exit from the airlock for the movement towards roof. The personnel shall again wear gown/cap and remove additional shoe cover in the airlock for the movement in the passage.
      2. The person entering into the service floor at second floor /fourth floor shall wear additional shoe cover over/additional cap.Personnel shall remove additional shoe cover and cap while existing from the service floor.
      3. Personnel shall wear shoe cover prior to entry into the purified water generation/distribution plant; the personnel shall remove the shoe cover while exiting from the purified water generation/distribution plant.
   3. Gowning Code:

Blue: Engineering Department

Brown: Housekeeping Department

White: All Staff and workmen and visitors

5. TRAINING:

Trainer:  Head – Quality Assurance 

Trainees:   All employees 

6. DISTRIBUTION:

Controlled Copy No. 1 :  Head of Department – Quality Assurance

Controlled Copy No. 2 : Head of Department – Engineering/                                                    Maintenance

Controlled Copy No. 3 :  Head of Department – Production

Controlled Copy No. 4 :  Head of Department – Packaging

Controlled Copy No. 5 : Head of Department – Warehouse

Original Copy :  Quality Assurance

7. ANNEXURE(S):

Nil

8. REFERENCE(S):

Nil

9. REVISION HISTORY CARD: 

Sr. No.	Revision No.	Change Control No.	Details of Revision	Reason(s) for Revision
1	00	—	New SOP	New SOP