Spare Parts , Purpose:
Spare Parts , To lay down the procedure for Cleaning, Labeling & Storage of spares in spare parts room at the Production Area.
Spare Parts , Scope:
This SOP is applicable for the Production Area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows :
Operator
[][]To follow the laid down procedure
Executive, Production
[][]To monitor and check the procedure is followed
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Procedure :
General Instructions
[][]Store all the clean and dry spare parts in the lockers or on the racks in separate polythene bags. Never keep any parts in the spare parts room without covering them.
[][]All the equipment parts stored in the spare parts room must be affixed with properly filled status label to identify the parts and its cleaning status.
[][]Production supervisor must regularly check the status label to avoid any error in the labeling.
Storing of utensils and accessories
[][]Store all the clean utensils and accessories in the lockers or in the racks in the separate polythene bags. Never keep any parts in the spare parts room without covering them.
[][]All the equipment parts stored in the spare parts room must be affixed with properly filled status label to identify the parts and its cleaning status.
[][]Record the use of utensils and accessories in the ‘Spares Use Register Book’ (Annexure I).
[][]Production supervisor must regularly check the status label to avoid any error in the labeling.
Storing of Dies and punch boxes
[][]Wipe the outside of the boxes with clean duster, then with 70% IPA solution (if necessary). Clean the dies and punches according to the Tablet Compression Machine SOP.
[][]Record the use of dies and punches in the ‘Spares Use Register Book’ for using dies and punches. Check the condition of punches before issuing and receiving.
[][]Storing of different size change parts of capsule filling machine
[][]Keep the clean and dry machine parts in the spare parts room in separate polybag and affix with properly filled status label.
[][]Record the use of Capsule Filling Machine change parts (e.g. Cutter, forming channel etc.) in the ‘Spares Use Register Book’.
Storing of blister change parts
[][]Wipe the outside of the boxes with clean cloth, then with 70% IPA solution (if necessary).
[][]Keep the clean and dry blister change parts in the locker dedicated for blister change parts.
[][]If there is no spare space in the locker keep the change parts in a polybag with proper status label and then place in clean pallet.
[][]Record the use of Blister parts (e.g. Cutter, forming channel etc.) in the ‘Spares Use Register Book’. Check the condition of blister parts before issuing and receiving.
Annexure:
Annexure I Spare Parts Usage Log Register