03- IN-PROCESS CHECKS OF TABLETS AT COMPRESSION STAGE (PHARMACEUTICAL)

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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