OBJECTIVE
To describe a procedure for entry of personnel and the visitors entering the mask production unit, as per requirements of cGMP.
SCOPE
The procedure applies to all the staff and visitors entering the mass production unit.
RESPONSIBILITIES
- It shall be the responsibility of all staff and visitors to follow this procedure.
- Supervisors shall be responsible for ensuring compliance as per this procedure.
PROCEDURE
Entry Considerations
- All employees should report about their illness or abnormal health condition to their immediate supervisors. A person showing apparent illness or open lesions shall not be allowed to enter till his / her condition is no longer judged to be at risk.
- Eating, drinking, chewing, smoking, storage of food, drinks, smoking materials, and personal medication is prohibited in the production area.
- No cosmetics or Jewellery is permitted in the production area.
Entry procedure
- Wash or sanitize your hands at entry as per SOP.
- Enter the personnel entry area.
- Remove the street clothes and footwear and place them in the lockers provided.
- The clothes and footwear shall be covered with clean plastic bags before they are kept in the designated lockers.
- The clothes shall be placed in the upper part of the lockers while the footwear shall be placed in the lower part of the lockers.
- Collect and wear uniforms as per SOP ‘Gowning Procedure’.
PEOPLE ALSO READ: SOP for Operation and Cleaning of Facemask Making Machine
Exit Procedure
- Enter the personnel entry and exit area and remove factory footwear and uniform.
- Place the factory uniform and footwear in separate polybags and keep them in designated lockers.
- Put the dirty uniforms in the drum provided for linen meant for laundry.
- When going for a break, leave the uniforms and footwear in designated lockers, ensuring that they are covered in a clean polybag.
- Put on street clothes and footwear and exit the facility.
- Wash and sanitize your hands on the way out.
Entry Procedure for visitors
- The entry considerations and entry and exit procedure for visitors shall be the same as for staff members.
- Visitors shall always be accompanied by departmental heads or their representatives.
- Visitors shall fill in the visitor’s log sheet.
ABBREVIATIONS
SS – Stainless Steel
SOP – Standard Operating Procedure
QC – Quality Control
ANNEXURE
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REVISION HISTORY
Nil
PEOPLE ALSO READ: SOP for Operation and Cleaning of UV Sterilizer
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