2.1 To define the laydown procedure for the change room while entering and leaving the workplace in the manufacturing unit.
3.0 SCOPE
3.1 This process shall be applicable to the dress code and changing uniform of employees manufacturing unit.
4.0 RESPONSIBILITY
4.1 HR Officer and above shall be responsible for the preparation & execution of this SOP.
4.2 HR and QA shall be responsible for the review of this SOP.
4.3 HR Head /QA Head and Section Heads shall be responsible to ensure the compliance of the procedure and implementation of this SOP respectively.
5.0 DISTRIBUTION
5.1 Quality Assurance
5.2 Quality Control
5.3 Production
5.4 Warehouse
5.5 Engineering
5.6 Human Resources
5.7 Analytical Laboratory
6.0 DEFINITIONS
6.1 Definitions
6.1.1 A room or area designated for changing one's clothes. Changing rooms are provided in a semi-public situation to enable people to change clothes in privacy, either individually or on a gender basis.
7.0 ABBREVIATIONS
7.1 Abbreviations
7.1.1 QA : Quality Assurance
7.1.2 SOP : Standard Operating Procedure
7.1.3 HR : Human Resources
7.1.4 NA : Not Available
7.1.5 Dept. : Department
7.1.6 DOJ : Date of Joining
7.1.7 IPA : Iso Propyl Alcohol
8.0 PROCEDURE
8.1 Entry Procedure
8.1.1 Enter to change room from the outer corridor.
8.1.2 Remove street footwear in the designated area, if applicable
8.1.3 Remove personnel belonging like wrist watches, jewelry, other ornaments, etc, and keep them in the lockers provided
8.1.4 Collect Apron /Coat from the locker and wear
8.1.5 Wear the clean cap
8.1.6 Crossover the bench and wear the factory footwear, if applicable, or wear the shoe cover one by one and cross the cross over bench
8.1.7 Look attire into the mirror for proper gowning
8.1.8 Disinfect your hands with 70 % IPA provided in the change room
8.2 Exit Procedure
8.2.1 Enter the change room
8.2.2 Remove the factory footwear and keep it in the cabinet of the crossover bench then cross the crossover bench. If the shoe cover is worn then directly cross the cross over bench
8.2.3 Remove the primary gown (shirt, trousers, and cap) and put it in the “Used Garment Bin”
8.2.4 Remove the shoe cover and put it in the “Waste Bin”
8.2.5 Take your belongings from the locker
8.2.6 Wear street footwear as applicable and exit from the change room
8.2.7 During lunch/break if one needs to come out from the production area, keep a shirt, trousers, and cap under the lockers provided in the change room before crossover the bench.
8.3 Approved colors for different departments are as under:
|
Department |
Approved
Color |
|
Production Area |
Dark Blue Apron Shirt with hood |
|
Staff |
White Coat |
|
QA |
White Coat |
|
QC / Microbiologist |
White Coat |
8.0 REFERENCES
8.1 References
8.1.1 In-house
END OF DOCUMENTS
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4. List of All SOPs and Documents for Clinical Research
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