To describe a standard operating procedure for entry and exit of Pharma Block.
1.0 PURPOSE:
To describe a standard operating procedure for entry and exit of Pharma Block.
2.0 SCOPE:
The SOP describes in detail the method for entry and exit of Pharma Block.
3.0 RESPONSIBILITY:
The responsibility of ensuring for entry and exit of Pharma Block as per the SOP lies with the staff of rank not lower than chemist of production department.
The responsibility of preparing, reviewing and approving the SOP lies with the Officer / Executive (Production), Head of Production and Head of QAD respectively.
4.0 METHOD:
4.1 FOR OPERATING PERSONNEL:
4.1.1 ENTRY:
4.1.1.1 Operating personnel shall enter the staging room, after ensuring that the entry room door is in closed position.
4.1.1.2 Operating personnel shall sit on the cross over bench, wear disposable shoe covers, disposable nose mask. Ensure that the nose mask covers nose and mouth.
4.1.1.3 After crossing the cross over bench take the clean room dress from the designated place and wear over the dress which covers head and ears. Put small quantity of 70% aqueous IPA from squeeze bottle into the palm and rub both the hands with it.
4. 1.1.4 Operating personnel shall ensure that the entry door of staging room is in closed position before opening the entry door of primary pharma room.
4.1.2 EXIT:
4.1.2.1 Operating personnel shall enter the staging room and ensure that the entry door of primary pharma room is in closed position.
4.1.2.2 Operating personnel shall remove and keep the clean room dress in the designated place.
4.1.2.3 Operating personnel shall remove disposable shoe covers, nose mask and keep them in the waste basket.
4.1.2.4 Operating personnel shall enter the entry room after ensuring the entry door of primary pharma room is in closed position.
4.1.2.5 Operating personnel shall exit from entry room, after ensuring the entry door of staging room is in closed position.
4.2 FOR SUPERVISORY PERSONNEL:
4.2.1 ENTRY:
4.2.1.1 Supervisory personnel shall enter the staging room after ensuring that the entry room door is in closed position.
4.2.1.2 Supervisory personnel shall remove the apron and keep it in the designated place for used aprons.
4.2.1.3 Supervisory personnel shall sit on the cross over bench, wear disposable shoe covers, disposable cap and nose mask. Ensure that the cap covers the head and ears, while the nose mask covers nose and mouth.
4.2.1.4 After crossing the cross over bench wear clean room apron over the dress and put small quantity of 70% aqueous IPA from squeeze bottle into the palm and rub both the hands with it.
4.2.1.5 Supervisory personnel shall ensure that the door of staging room is in closed position before opening the entry door of primary pharma room.
4.2.2 EXIT.
4.2.2.1 Supervisory personnel shall enter the staging room and ensure that the entry door of primary pharma room is in closed position.
4.2.2.2 Supervisory personnel shall remove clean room apron and keep it in the designated place.
4.2.2.3 Supervisory personnel shall sit on the cross over bench, remove disposable shoe covers, disposable cap and nose mask, keep them in the waste basket.
4.2.2.4 Supervisory personnel shall wear apron and enter the entry room after ensuring that the entry door of primary pharma room is in closed position.
4.2.2.5 Supervisory personnel shall exit from entry room after ensuring that the entry door of staging room is in closed position.
4.3 FOR VISITORS:
4.3.1 ENTRY.
4.3.1.1 Visitors shall enter the staging room, after ensuring that the entry room door is in closed position.
4.3.1.2 Visitors shall remove the apron and keep it in the designated place for used aprons.
4.3.1.3 Visitors shall sit on the cross over bench, wear disposable shoe covers, disposable cap and nose mask. Ensure that the cap covers the head and ears, while the nose mask covers nose and mouth.
4.3.1.4 After crossing the cross over bench wear clean room apron over the dress and put small quantity of 70% aqueous IPA from squeeze bottle into the palm and rub both the hands with it.
4.3.1.5 Visitors shall ensure that the door of staging room is in closed position before opening the entry door of primary pharma room.
4.3.1.6 The supervisor/official accompanying the visitors shall ensure that the entry door is in closed position before opening the other door.
4.3.2 EXIT.
4.3.2.1 Visitors shall enter the staging room and ensure that the entry door of primary pharma room is in closed position.
4.3.2.2 Visitors shall remove clean room apron and keep it in the designated place.
4.3.2.3 Visitors shall sit on the cross over bench, remove disposable shoe covers, disposable cap and nose mask, keep them in the waste basket.
4.3.2.4 Visitors shall wear apron and enter the entry room after ensuring that the entry door of primary pharma room is in closed position.
4.3.2.5 The supervisors/official accompanying the visitors shall ensure that the entry door is in closed position before opening the other door.
Production, operating, process checks
