AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
1. Context of Observation
During the WHO GMP…
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Incident
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
1. Context of Observation
During the WHO…
INVESTIGATION REPORT FOR THICKNESS VARIATION OBSERVED IN TABLETS DURING COMPRESSION STAGE
Background
During routine in-process quality checks performed during tablet compression, significant variation…
INVESTIGATION REPORT FOR THE OBSERVATION OF WEIGHT VARIATION BEYOND LIMIT DURING COMPRESSION
During routine in-process checks performed during compression of Paracetamol 500 mg Tablets, tablet weights were…
INVESTIGATION REPORT FOR THE OBSERVATION OF CAPPING DURING COMPRESSION
Background
During routine compression of Paracetamol 500 mg Tablets, operators observed separation of the upper…
INVESTIGATION REPORT FOR PICKING OF TABLETS OBSERVED DURING COMPRESSION
Background
During routine compression activity of Paracetamol 500 mg Tablets, operators observed that portions…
INVESTIGATION REPORT FOR WEIGHING BALANCE CALIBRATION FAILURE OBSERVED DURING DISPENSING STAGE
During routine dispensing activity for batch PGH/L/XX-NNN, the weighing balance used for dispensing of raw…
INVESTIGATION REPORT FOR CROSS-CONTAMINATION OBSERVED BETWEEN PRODUCTS DURING GRANULATION STAGE
During routine in-process inspection at the granulation stage, foreign granules with different color and…
INVESTIGATION REPORT FOR THE OBSERVATION OF SIFTER MESH DAMAGE DURING GRANULE SIFTING OPERATION
Background
During routine granule sifting operation using the vibratory sifter, the operator observed abnormal…
INVESTIGATION REPORT FOR WATER BATH DAILY TEMPERATURE MONITORING RECORD WAS NOT AVAILABLE
Water baths are critical equipment used in pharmaceutical manufacturing laboratories and production areas for…