DATA INTEGRITY: ALCOA AND ALCOA PLUS
ALCOA TERM DEFINITION Attributable Attributable means information is captured in the record so that it is uniquely identified as executed by the originator of…
SOP FOR CLEANING PROCEDURE OF GENERAL MICROBIOLOGICAL TESTING AREA 3
1.0 OBJECTIVE:- The objective of this SOP is to lay down a procedure for cleaning procedure of general microbiological testing area. 2.0 SCOPE:– This SOP…
SANITIZATION TECHNIQUES FOR WATER SYSTEM IN PHARMA
SANITIZATION:- Microbial control in water systems is achieved primarily through sanitization practices. Systems can be sanitized using either thermal or (photo-) chemical means. THERMAL SANITIZATION:-…
WATER SYSTEM IN PHARMACEUTICAL INDUSTRY
PREFILTRATION: – The purpose of prefiltration—also referred to as initial, coarse, particulate, or depth filtration—is to remove solid contaminants from the incoming source water…
ROUGING PHENOMENA IN PHARMACEUTICAL WATER SYSTEM
Rouging is seen in many water systems, usually high temperature (80°C) distilled water and clean steam systems. Rouge is not limited to storage and…
AIR CHANGE RATE (ACH) TEST FOR CLEAN ROOMS
The purpose of the air change rate test is to determine the number of times the air is being exchanged within the cleanroom on an…
GLASS: PACKAGING MATERIAL USED IN PHARMA
American Society for Testing and Materials (ASTM) defines glass as an inorganic product of fusion that has cooled to a rigid condition without crystallizing. ASTM…
ACIDIFICATION/DEGASIFICATION PROCESS OF WATER SYSTEMS IN PHARMA
The process is well known and accepted in water purification systems. It is usually used where there is a high flow rate (>50 gpm…
SOP FOR CLEANING PROCEDURE OF GENERAL MICROBIOLOGICAL TESTING AREA 2
1.0 OBJECTIVE:- The objective of this SOP is to lay down a procedure for cleaning procedure of general microbiological testing area. 2.0 SCOPE:– This SOP…
SOP FOR IN PROCESS CHECKS DURING LIQUID ORAL MANUFACTURING AND PACKING
1.0 Objective: – To lay down the procedure for in-process checks during liquid oral manufacturing and packing. 2.0 Scope: – This procedure is applicable…
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