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In Process Checks During Manufacturing
In Process Checks During Manufacturing
packing) in order to monitor and if necessary to adjust the process and/or to ensure that the
intermediate or finished product conforms to its specification. The control of equipment and
environment may also be regarded as the part of in process control.
In process checks are vital as manufacturing activity itself and the same shall be performed at
regular intervals. Frequency of the in process checks need to be realistic.By carrying out in
process checks one can assure the product quality.
In process quality check is designed to provide early warning for quality or other problems
arising during production. In Other words it is intended to provide a snap shot of the quality of
the product manufactured at the factory. The objective of in process checks are both quality
control and process control.
In process checks shall include following process controls.
l Measured values obtained from process equipment. e.g. Inlet & outlet temperature of FBD
l Measured values obtained from persons e.g. Times
l Product attributes e.g.Weight,Hardness,friability
l Measured values obtained from the room environment e.g. Temperature, Humidity.
Note: Rejected in process materials should be identified and controlled under a
quarantine system designed to prevent their use in manufacturing.
During process checks following things needs to be checked
l Verification of the status labels on the area, equipments & process containers.
l Online stage wise review of the batch record (Online review).
l Cleanliness of the area, equipment and line clearance.
l Confirming material correctness, AR.no, quantity & vendor against the batch record.
l Product attributes like weight variation, avg.wt, hardness, thickness, D.T, friability.
l Monitoring environmental conditions.
l Weight of the blend & other intermediates.
l Checking the appearance tablet during compression & coating
l Solution preparation.
l Film formation and integrity.
l Ensure machine setting parameters match with batch records.
l Yield verification of various stages of production
l Sampling
Documentation
Results of the in process checks shall be documented with initials of the person carrying them
out and results obtained. If problems or deviations from the manufacturing formula and
processing instructions occurred, all relevant information associated to this have to be
documented well.