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…
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT OF COLD STORAGE ROOM
The objective of the performance qualification is to demonstrate that the process as operated under
normal…
PERFORMANCE RE-QUALIFICATION PROTOCOL CUM REPORT OF COMPRESSED AIR
The purpose of carrying out Performance Re-Qualification of Compressed Air System is to establish the documented…
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…
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…
AUDIT COMPLIANCE REPORT FOR VENDOR QUALIFICATION SYSTEM INADEQUATE
1. Context of Observation
During the WHO GMP inspection conducted at AABBCC Pharmaceutical Plant, the inspection…
CHECKER VALIDATION PROTOCOL
PURPOSE:
The purpose of this document is to qualify, confirm and verify that the visual checkers consistently…
PACKAGE LEAFLET: INFORMATION FOR THE Esomeprazole Enteric-Coated & Domperidone Sustained-Release Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Brand namexxx (Esomeprazole Enteric-Coated & Domperidone…