SOP for secondary gowning in store

OBJECTIVE:To lay down the procedure for secondary gowning in store while working in dispensing and sampling area.

SCOPE:This SOP is applicable for secondary gowning of stores while working in dispensing and sampling area in store.

REFERENCE:In-house

RESPONSIBILITY:

1. Store/QC/QA/Production personnel: – Follow the procedure as per SOP.

2. Store head: – To ensure that SOP is being followed and proper execution of SOP.

3. QA: – To ensure that SOP is being implemented properly.

DISTRIBUTION:

Store, QC and Production

ABBREVATIONS:

SOP : Standard Operating Procedure

QA : Quality Assurance

QC : Quality Control

IPA : Isopropyl alcohol

PROCEDURE:

1. Enter into the store area as per SOP no- SOP/P/QA/15.

2. While going for sampling and dispensing activity every personnel (Store, QA & Production- For Dispensing/ Store, QA & QC- for Sampling) must wear the primary gowning followed by secondary gowning.

3. During secondary gowning wear overgown, gloves and masks (which are kept at sampling or dispensing area airlock).

4. Before entering sanitize hands with 70% IPA.

5. Then enter into sampling or dispensing booth.

6. After completion of activity remove overgowns and keep them at their proper place in sampling or dispensing area airlock.

7. If they are found soiled or dirty keep it in polybags and should be taken away at the end of the shift at home for washing.

8. Put the mask and gloves in “Used masks and gloves” bin if they have become unusable.

FREQUENCY:

Every time during dis

pensing and sampling activity

ANNEXURE:

NA