Krishnaveni Pharma Job Consultancy

AREA LINE CLEARANCE CHECKLIST (Manufacturing Area / Packing Area)

AREA LINE CLEARANCE CHECKLIST (Manufacturing Area / Packing Area)

Area Name & Room No:
Previous Product:	Batch No:
Proposed Product:	Batch No:

‘Ö’ if cleaning is satisfactory or ‘X’ if cleaning is not satisfactory.

If the point is Not Applicable, then write NA

S. No.	Activity			Checked By PR	Verified By QA
	Status board updation			Yes No	Yes No
	Men entry & Material Entry Area:
	2.1 Cleaning of doors, covings, floor, walls, ceiling, electrical fixtures, personal protective equipment box, air supply & return grills, filters, mirror, dress cabinet, waste bin and cross over Bench.			Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
	2.2 Secondary gowning of previous product is removed.			Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
	Process Area: Cleaning of SOP stand, covings, floor, walls, ceiling, air supply & return grills, filters, electrical fixtures, waste bin, rejection bin, SS furniture, anti vibration table, utility lines, windows, doors, corners and SS railing.			Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
	Wash area:
	Covings, drain point, floor, walls and ceiling			Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
	General Inspection:
		All equipments are cleaned and labelled		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		All in-process testing instruments are cleaned and labelled		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Documents and product containers of previous product / batch are removed from the area.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Waste and rejects / left over quantity of previous product / batch are removed.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Tool box and cage trolley is devoid of previous product / batch.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		All in-process testing instruments are calibrated and calibration labels are affixed.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		All the status labels of previous batch removed from the area /equipment		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Cleaning of adjacent rooms if any		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Vacuum cleaner and bag are cleaned and labelled		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Equipments not in use in the current product are kept covered externally with stretch film wrap and cleaned label is affixed.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Equipments not used in previous product but will be used in current product are cleaned.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Surface beneath the equipments is cleaned		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Colour coding and calibration status of utility lines		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Ensure balance levelling and calibration status		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Calibration and PMP status of all equipments and instrument is updated		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Rejection containers are cleaned and labelled		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		All door interlocks are functioning		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Drain point is cleaned		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Complete area cleaning is found satisfactory		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Area cleaning details (scheduled disinfectants) are entered in area log book. And all the other log books are updated		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
		Ensure that cleaning validation swab / rinse sample completion and results are satisfactory.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
	5.22	All secondary packing line area, machines & In process testing instruments cleaning status & entries of equipment log books		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
	5.23	Equipment /s not in use in the current product is kept covered externally.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
	5.24	All Rejection trays / bins, Crates, Cage trolleys, Underneath of Conveyor belts & all Panel boards.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
	5.25	Removal of previous coding details, Previous Pharma code / Barcode and check weighed limits from respective systems.		Satisfactory Not Satisfactory NA	Satisfactory Not Satisfactory NA
Remarks (if any):
Checked By: Production Sign & Date:_____________ Time:__________			Verified By: Quality Assurance Sign & Date:_____________ Time:_______