LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION

November 12, 2018February 2, 2023 Pharmaceutical Guidanace

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION

Dosage Form:		Date / Time:
Product:		Batch No. :
Previous product:		Batch No. :

Image result for BINDER PREPARATION

Stage areas / room & equipment	Checks		Checked by Production Date & Time		Counter checked By Quality Assurance Date & Time
BINDER PREPARATION [Released / Not Released / Hold / Rejected / Not Applicable]
Binder Preparation Area	Room ID: ____________________ Ensure the absence of batch documents, labels, materials or remnants of previous product or batch. Ensure ‘CLEANED’ label is affixed on each equipment. Ensure updation of Status Board Temperature [24 ± 2°c] Relative Humidity [35 – 50 %] Differential Pressure [10 – 26 Pascal]
	CLEANLINESS OF Floor Walls Ceiling Drain Supply air Grills	Containers Tools Vacuum cleaner Waste Bins Light Fixtures Return air Grills
Steam Jacketed Vessel	Equipment ID: ____________________ CLEANLINESS OF Ensure the absence of batch documents, labels, materials, paste, traces of water or remnants of previous product or batch. Cleaned Label Present Area surrounding the Equipment

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