Master Formula that was not approved
During the WHO GMP inspection conducted at the AABBCC pharmaceutical manufacturing facility, the following…
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Investigation Reports
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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 LAMINATION OF TABLETS OBSERVED DURING COMPRESSION
Background
During routine compression activities for Paracetamol 500 mg Tablets, operators observed separation…
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 STICKING OF TABLETS TO PUNCHES OBSERVED DURING COMPRESSION STAGE
During routine tablet compression of Paracetamol 500 mg Tablets, operators observed granule material adhering to…
PROTOCOL COM REPORT FOR PRESSURE DIFFERENCE QUALIFICATION
To determine the procedure for Pressure difference qualification and to establish that desired quantity of air…
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 INCORRECT API DISPENSING OBSERVED DURING DISPENSING STAGE
During dispensing verification of raw materials for batch PGH/L/XX-NNN, it was observed that the quantity of…