In a pharmaceutical Industry in process check is very important subject and this also a part of quality assurance department. So we may say QA department is the father of every manufacturing Company.... here i describe about IPC.........
In-Process
Control refers to the checks performed during an activity (it can be
manufacturing or 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, equipment's & 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
In
Process Checks During Manufacturing:-
l # Ensure correct materials are
brought in for manufacturing activity.
l # Check sieve integrity.
l # Ensure manufacturing is
carried out as per the instruction given in the BMR.
l # Ensure operators are wearing
hand gloves and nose mask during all stages of manufacturing.
l # Verify the records for online
entries.
l # Environmental Monitoring.
l # Check & verify equipment
parameters like temperature, drying time etc.
l # Checking process parameters
like Appearance,Avg.Weight,Group Weight,Hardness,friability, DT etc.
l # Yield verification.
l # Checking the weights of in
process materials.
l # Checking labeling status of
the quarantine materials.
l # Ensure doors are closed
during processing.
In Process Checks During packing:-
l # Ensure Name, Strength, Volume
& quantity is correct.
l # Check the status labels on
equipment, area & in process container.
l # Over printing quality.
l # Batch coding details on
primary & secondary pack (B.No.,Mfg.,Exp., M.R.P.etc.).
l # Text matter on the ptd. foil
& carton.
l # Verification forming &
sealing temperature.
l # Ensure blisters are free from
knurling defects.
l # Leak Test.
l # Pharmacopeial status of the
material used is correct.
l # Mfg.License number is printed
correctly.
l # Preprinted packing materials
provide mandatory information & legal status.
l # Storage conditions details
available in the packaging materials.
l # Directions for use details
available in the packaging materials.
l # Ensure warnings against wrong
administration is provided in the pack.
l # Storage condition is
same all printed packing Materials.
l # Ensure correct leaflet is
used for the product.
l # Verify printed matter on the
outer cartons and shippers.
l # Ensure checkers are
performing their activity in a proper way.
l # Verify blisters & strips
for alignment defects & empty pockets.
l # Ensure doors are closed
during processing.
l # Verify the records for online
entries.
l # Environmental Monitoring.
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.
Thank You
