In this post Standard Operating Procedure Handling and Dispensing of Steroids in Pharmaceuticals is describe.
PURPOSE:
To provide a procedure for Handling and Dispensing of Steroids.
SCOPE:
Applicable to steroids like Fluticasone Propionate, Budesonide, Beclomethasone Dipropionate, Dexamethasone, Prednisolone etc.
RESPONSIBILITY:
Stores, Production, Quality Assurance and Quality Control.
DEFINITION:
Not Applicable
1.0 HEALTH, SAFETY AND ENVIRONMENT:
1.1 Use personal protective equipments like 3M dust masks ,disposable gloves, safety googles, colour coded gown or disposable gowns (Tyvek suit) while sampling ,dispensing and handling of steroid material.
2.0 PROCEDURE:
2.1 Point to be modified as ‘On receipt of Steroids, check and receive the material as per SOP.
2.2 Check all the containers for any damage. If any discrepancy is observed, bring it to the notice of Quality Assurance for further action as per SOP. Damaged container of steroid should not be redressed for any reason. (If any container is found damaged and exposed, it should be immediately covered with double bags).
2.3 All the containers should be dedusted with the help of vacuum cleaner / lint free cloth in the dedusting area and enclosed in a fresh polybags.
Note: While handling damaged container in receiving area personal protective equipment should be used as per point no. 1.1.
2.4 Enclosed containers should be carried to Stores area and stored in the designated compartment present in mobile rack.
2.5 Carry out the dispensing activity as per SOP and sampling activity as per …………..
2.6 Clean the steroid container after every dispensing / sampling with the help of vacuum cleaner / lint free cloth and enclose the container in fresh polybag before removing from the cubicle.
2.7 Use item dedicated cleaned scoop/ spoon/ spatula for dispensing / sampling activity.
2.8 After the dispensing / sampling activity is over, continue to run the RLAF for further 10 minutes.
2.9 Collect the spillage material (if any during dispensing/sampling) with the help of vacuum cleaner and clean the area as per cleaning procedure. Transfer the spilled material, lint free cloth, hand gloves, 3M nose mask and disposable gown (Tyvek suit if any) in to destruction vessel. Deactivate them with sodium hypochlorite solution.
2.10 After dispensing/sampling wipe the RLAF, perforated table (if present), pallet (if present), weighing balance table, weighing balance with moist lint free cloth and rinse should be deactivated with Sodium Hypochlorite Solution).
2.11 Clean the dispensing/sampling area as per SOP ………….
2.12 In case of any spillage of steroid (Raw material / Finished products) in storage area should be deactivated using 5% Sodium Hypochlorite solution and cleaned immediately. Refer SOP ……………
2.13 After every dispensing / sampling, dispose off 3M dust masks and hand gloves after deactivation.
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