03- IN-PROCESS CHECKS OF TABLETS AT COMPRESSION STAGE (PHARMACEUTICAL)
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03- IN-PROCESS CHECKS OF TABLET COMPRESSION
· Check the status of the Q.C.'s released label and Report of Bulk in
the batch production record file.
· Check that the ingredients, containers, labels, and documents from
preceding batches have been taken out.
· Check the cleanliness of the ceiling, floor, doors, windows, and
other surfaces.
· Check the dust collector is turned on and operating correctly.
· Check the HVAC system's functionality.
· Check that the analytical balance, compression machine, and other
tools are correctly cleaned and calibrated.
· Check that everyone using protective gear is carrying it out
correctly.
· Check the physical characteristics, color, dimension, weight,
thickness, hardness, disintegration time, etc are in compliance with the
product's specifications at the beginning of the compression run.
· Check that the process is being followed by the SOP.
· Check that the machine operators are operating the machine by the SOP.
· Check that the cleaning is maintained throughout the process.
· 20 tablets are required for weights at the beginning of
compression.
· Compression will begin at the release of the in-process Test including
Physical Appearance, Weights variation, Thickness, Hardness, and Disintegration
test.
· After 30 minutes, verify the tablet's weight and subsequently perform
production checks.
· After 30 minutes, check the
tablet's hardness.
· Check the average weights of 10 tablets and make sure they fall
within the allowed range by recording the data on the weight control sheet.
· After two to three hours, take a random sample to see if the D-Time
is within acceptable limits.
· Check that the compressed tablets are being stored
correctly.
· Check the tablets are stored in controlled Environmental
conditions.
· Check that the Tablets are kept in quarantine until
Q.C. results
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