Procedure
for Line clearance
·
After receiving intimation for line clearance
from Production, Q.A Officer
visit the concerned department.
visit the concerned department.
·
Check that work station is clean of previous
product and spillage on the line
area is suitably mopped and cleaned.
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.
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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