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SOP for Entry, Exit in production & Quality Control Area


PURPOSE
To lay down the procedure for Entry, Exit in production & quality control area.

SCOPE
This procedure is applicable at XYZ Limited for Entry, Exit in production & Quality control area.

RESPONSIBILITY
All personnel entering in the plant

ACCOUNTABILITY
Head Quality Assurance


PROCEDURE
Entry procedure in plant
  • Personnel must follow the below mentioned procedure while entering in the production area.
  • Personnel shall keep their belongings in the shelves provided by the company.
  • Afterwards remove the street shoes on the shoe rack and wear the foot wears which are provided by the company.
  • Now personnel shall enter into the change room and wash their hands.
  • The slippers are to be removed into the provided space in crossover bench placed in change room.
  • Afterwards Personnel shall cross through the cross over bench and wear those slippers which are provided on other side of cross bench. The separate colour code is defined for different Department.
  • The Personnel shall wear the cap covering the hairs completely.
  • The Personal Shall wear nose mask.
  • Afterwards wear the respective colour of aprons provided by the company.
  • Check the outfit in mirror for proper gowning.
  • The Personnel must sanitize hands with disinfectant 70% IPA kept in dispenser.
  • Enter into Plant.
  • Use Separate change room for worker & staff as provided by company.
  • For understanding more efficiently the procedures refer to photographic displays.
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Secondary gowning before entering in manufacturing & filling area.
  • Secondary gowning shall be done while entering into production manufacturing & filling areas.
  • Cover slippers with shoe covers
  • The Person shall wear nose mask.
  • Wear gloves.
  • Sanitize hands with hand sanitizer & enter into respective areas.
Secondary gowning before entering in Raw material stores :
  • Before entering into dispensing & sampling booth secondary gowning shall be done.
  • Cover slippers with shoe covers.
  • Personnel shall wear disposable caps.
  • The Person shall wear nose mask.
  • Disposable Over gowning shall be done.
  • The person shall Wear gloves which are involved in sampling or dispensing.
  • Sanitize hands with hand sanitizer & enter into respective booths.
Entering procedure for visitors
  • Visitor shall wear shoe covers.
  • Crossover the cross bench.
  • Visitor shall wear aprons as per provided by company.
  • Wear nose mask.
  • Check the onfit in mirror for proper gowning.
  • Sanitize hands with hand sanitizer & enter into respective areas.
  • For understanding more efficiently the procedures refer to photographic display.
Exit procedure:
  • Personnel leaving the change room should change the factory dressings (apron, cap) in linen waste bin.
  • Disposable caps or mouthpiece shall be kept in waste bin.
  • Keep the footwears or Shoe cover of the company in the cross bench & cross through the crossing bench.
  • Wear the slippers kept on the other side of cross bench.
  • Exit through the change room.
  • Personnel shall remove the slippers of the company on the stand collect their foot wears & belongings from the shelves provided by the company.

PEOPLE ALSO READ: SOP on Standard Operating Procedures in Pharmaceutical

REFERENCES
Nil

ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control

ANNEXURES
Nil

REVISION HISTORY
Nil

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