Entry and Exit Procedure of Dispensing Area
1.0 OBJECTIVE :
1.1 To lay down a procedure for entry and exit from dispensing area.
2.0. SCOPE :
2.1 This procedure is applicable for raw material dispensing area entry and exit at ABC Pharma
3.0. RESPONSIBILITY :
3.1 Store Officer
3.2 IPQA Officer
4.0. ACCOUNTABILITY :
4.1 Head of the department
5.0. PROCEDURE :
5.1 Every person who is required to enter into dispensing area of liquid and ointment store shall follow.
5.2 To enter the dispensing room follow the below mentioned steps:-
5.2.1 Open the door of Man air lock of dispensing area.
5.2.2 Enter in the Man air lock and remove the company foot wear and keep in SS swing over bench.
5.2.3 Sit on the swing over bench .
5.2.4 Take the turn and cross the SS swing over bench.
5.2.5 Take the garment bag kept in S.S. cabinet dedicated for product dispensing
5.2.6 Take the head gear mask, wear it taking care that all hairs are covered.
5.2.7 Wear gown tucking head gear mask inside neck of gown.
5.2.8 Take a pair of booties and wear in feet one after one by sitting on the cross over bench, wear a pair of slipper kept in swing over bench.
5.2.9 See in the mirror to ensure the completeness of gowning
5.2.10 Wear the hand gloves on both the hands.
5.2.11 Sanitize hands with 70% IPA solution kept in Spray Bottle.
5.2.12 Open the door of dispensing with elbow and enter the dispensing room.
5.3 Exit procedure from dispensing area.
5.3.1 At the end of the day or as and when any person required to come out from dispensing is follow the procedure given below
5.3.2 Open the door of dispensing remove the slipper and keep in SS swing over bench.
5.3.3 Remove the hand gloves, booties, gown and then head gear mask and keep them in drum Labeled as “ USED GARMENTS”.
5.3.4 Sit on the swing over bench.
5.3.5 Take the turn and cross the SS swing over bench.
5.3.6 Wear the company sleeper from SS swing over bench.
5.3.7 Open the door of Man air lock and exit.
5.4 Precaution before exit from dispensing area:-
5.4.1 Ensure that Reverse Laminar Air Flow is off when the work has finished.
5.4.2 Ensure that all the container / bags are properly closed.
5.4.3 Ensure that no material is lying on the floor / balances.
6.0. ABBREVIATION :
Sr. No. | Abbreviation used | Full form of abbreviation used |
1 | SOP | Standard Operating Procedure |
2 | IPA | Isopropyl alcohol |
3 | SS | Stainless steel |
4 | TA | Tablet |
5 | PA | Personnel & Administration |
7.0 ATTACHMENTS (ANNEXES) :
7.1 N.A.
8.0. REFERENCE : In House
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipment
concurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
handling and investigation of Market Complaints