Thursday 26 September 2013

Procedure for Line clearance



Procedure for Line clearance
·         After receiving intimation for line clearance from Production, Q.A Officer
visit the concerned department.
·         Check that work station is clean of previous product and spillage on the line
area is suitably mopped and cleaned.
·         See name of product, batch no, batch size, manufacturing and expiry date.
·         Check that all relevant documents are complete in file.
·         Issue line clearance after confirmation that all the requirements of check list of the relative process have been fulfilled.
·         Check that humidity/temperature of area (if necessary) is suitable for process.
·         Check that all the ingredients are present and identified properly with reference to product specification.
·         Check that clean protective clothing, gloves and masks are being used.
·         Check that all the ingredients are properly identified with product name, batch no, material name and quantity.
·         Assure the addition of active ingredients and other excipient under controlled humidity and temperature.
AT PACKAGING
·         Check that work station is clean of previous product and spillage on the line
area is suitably mopped and cleaned.
·          
·         Check all the packaging material identities of the product according to product specification.
·         Check that all the relevant record is complete.
·         Check that all the materials are released for packaging from Q.C.
·         Check the batch no, manufacturing and expiry date of product to be packaged and that printed on packaging material.
·         Check the compliance of line clearance at regular intervals of time.

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