LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING

Pharmaceutical Guidanace November 21, 2018 Audit and Guideline, Production Comments Off on LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING 2,461 Views

*Stage areas / Equipment Name*	Checks		Checked by Production Date & Time	Counter checked By Quality Assurance *Date & Time*
PACKING [Released / Not Released / Hold / Rejected / Not Applicable]
Packing Room	Room ID No.: ____________________ Ensure the absence of batch documents, labels, materials, powder, tablets, 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 Container	Light Fixtures Tools Waste Bins Supply air Grills Return air Grills Area under packing Machine
Blister Packing Machine / Strip packing machine / Defoiling Machine	Equipment ID No.: ________________ Ensure the absence of materials / Powder / tablets / Aluminum foil / PVC foil / PVDC foil / Printed foil / Strips / Blisters or remnants of previous product or batch & traces of water. Pass box cleanliness. Overprinting Stereos of previous batch or product are destroyed. Area surrounding the Equipment

Production and Process Controls