Standard Procedure for secondary gowning and de-growing for non-sterile processing areas.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for secondary growing and de-growing for all staff/visitors before entering into non-sterile processing areas in the pharmaceutical industry to avoid contamination.
2.0 Scope
This SOP is applicable for all secondary change areas before entering into non sterile processing areas, including manufacturing, filling, and blistering activities.
3.0 Responsibility
3.1 All staff/visitors are responsible for wearing secondary gowning before entering the non sterile processing areas.
3.2 The Production Pharmacist is responsible for the implementation of this standard procedure.
3.3 The HOP is responsible for ensuring the implementation of this SOP.
3.4 Quality Assurance Officer monitors the compliance of this SOP.
4.0 Definitions
4.1 Primary Gowning
Primary Gowning is initial gowning, including the change from street clothes to plant uniform.
4.2 Secondary Gowning
Wearing an additional gown over the primary gown before entering the processing areas.
4.3 De-Gowning
De-Gowning is the controlled removal of garments.
Note
Secondary gowning for non sterile processing areas includes a single-piece gown, including head cover.
Mask and shoes.
5.0 Procedure
5.1 Enter the secondary change area.
5.2 Remove your primary shoes and place them in the designated shoe racks.
5.3 Sit on the cross-over bench and step on the other side to take the cleaned secondary gown from the cabinet.
5.4 Wear the secondary gowning.
5.5 Take your secondary shoes from the designated racks and wear secondary shoes.
5.6 Set your gown in front of the mirror and wear a face mask.
5.7 Senitize your hands with hand sanitiser.
5.8 Enter into the non sterile processing area after opening the other door of the secondary change room.
6.0 De-Gowning
6.1 Enter the secondary change room after leaving the non sterile processing area.
6.2 Remove your secondary shoes and place them in the designated shoe racks.
6.3 Sit on the cross-over bench and step out to the other side.
6.4 Remove your secondary gown and place it in an uncleaned cabinet.
6.5 Wear your primary plant shoes and leave the secondary change area.
7.0 Precautions
7.1 Don’t enter processing areas without secondary gowning.
7.2 Don’t sit on the ground after wearing secondary clothing.
8.0 Abbreviations
8.1 SOP: Standard Operating Procedure
8.2 QA: Quality Assurance
8.3 HOP: Head Of Production
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