Drugsformulations
Entry & exit procedure in primary change room for personnel and visitors
Objective
To lay down a procedure for the entry and exit in primary change room for personnel and visitors.
Scope
This Standard Operating Procedure is applicable for all employees and visitors entering into the primary change room.
Responsibility
All employees and visitors of Pharmaceuticals Pvt. Ltd. shall be responsible for follow the procedure mentioned in this SOP.
Accountability:
Department Heads & QA Head shall be accountable for implementation of this SOP.
Abbreviations and Definitions
SOP: Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
QA:Quality Assurance.
COB: Cross over bench.
Procedure
Entry & exit procedure for personnel
Entry procedure from change room to primary production area.
Push the door of primary change room lobby.
Enter into the change room lobby and close the door of primary change room lobby.
Push the door of primary change room and enter into the primary change room.
Remove your street footwear and unwanted articles like wrist watch, ornaments etc. and keep them in respective lockers.
Wash your hands with liquid soap and dry under hand drier.
Sanitize your feet by using soak system having disinfectant.
Cross the cross over bench (COB) as displayed in pictorial.
Take your primary protective garments like company provided footwear, Cap, apron from the lockers & wear it accordingly.
Stand in front of mirror and ensure the completeness of the primary gowning.
Sanitize your hand with hand sanitizer.
Then go to primary production area (Respective work place) depending upon nature of job.
Exit procedure from primary production area
Pull the door and enter into the primary change room.
Remove your primary protective garments like apron and cap, company provided cleaned footwear, put them in the lockers.
Cross the cross over bench (COB) as displayed in pictorial.
Wear your street footwear and take unwanted articles like wrist watch, mobile phone, ornaments etc. from respective locker.
Wash your hand with liquid soap and dry under hand drier (if applicable).
Push the door of primary change room lobby.
Enter into primary change room lobby.
Push the door of main entrance of production area.
Exit from primary change room.
Entry & exit procedure for Visitors
Entry procedure from change room to primary production area:
Push the door of primary change room lobby.
Enter into the change room lobby and close the door of primary change room lobby.
Push the door of primary change room and enter the primary change room.
Take shoe covers from the visitor locker.
Sit on the cross over bench (COB) and wear shoe covers as per pictorial displayed in change room.
Cross the cross over bench (COB) by swinging the legs upon the COB.
Take disposable apron & cap from the locker and wear it.
Stand in front of mirror and ensure the completeness of the primary gowning.
Sanitize your hand with hand sanitizer.
Enter into primary production area.
Exit procedure from primary production area
Pull the door and enter into the primary change room.
Remove apron and cap, put them in dustbin.
Sit on the cross over bench (COB) and cross the COB by swinging the legs.
Remove shoe covers and put them in dustbin.
Wash your hand with liquid soap and dry under hand drier (If applicable).
Push the door of primary change room lobby.
Enter into primary change room lobby.
Push the door of main entrance of production area.
Exit from primary change room.
Forms and Records (Annexures)
Not applicable
Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Quality Control, Engineering, HR & Warehouse
History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
