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…
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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…
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…
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…
HOLD TIME STUDY PROTOCOL CUM REPORT FOR PANTOPRAZOLE DOMPERIDONE CAPSULES
Hold time – The established time period for which dispensed raw materials, intermediates (in-process materials),…
AUDIT COMPLIANCE REPORT OF TREND ANALYSIS OF DEVIATIONS NOT PERFORMED
Context of Observation
During the WHO GMP inspection conducted at AABBCC pharmaceutical manufacturing facility,…