Disintegration Test for Drugs
(A) Subjective: Procedure for performing Disintegration test. (B) Purpose: This procedure is applicable for performing dissolution test on drugs used in pharmaceutical company. (C) Name…
Category: Validation
FRIABILITY TEST
(A) Subjective: Procedure for performing Friability test on Tablets. (B) Purpose: This procedure is applicable for friability test on tablets and calibration of friabilator used…
Procedure for Cleaning and Monitoring of Clean Room Pass Boxes
Cleaning of Clean- Room Pass Boxes: (A) Subject: Procedure for Cleaning of Class- Room Pass Boxes. (B) Purpose: This procedure is applicable for Cleaning of Clean-…
Working Principles for Dynamic and Static Pass Boxes
(1) Dynamic Pass Box: Procedure on the working of Dynamic Pass Box. (A) Objective: This working principle is applicable for usage of Dynamic Pass Box in formulation…
Clean Rooms In Pharmaceutical Manufacturing
A Clean- Room is an environment in which several parameters (like Contamination, Pressurization, Temperature & Humidity and Personnel Access) are controlled, monitored and maintained. Basically…
Validation of Clean Room Pass Boxes
(A) Clean Room: A Clean Room is an area in which the quantity and size of air- borne particles are controlled in order to limit contamination.…
Pharmaceutical Quality/Manufacturing Standards (CGMP)- US FDA
Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances CATEGORY TITLE Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Compliance; Pharmaceutical…
Pharma Regulations and Guidelines-India, Easy Access Links
(1). Regulations & Guidelines: CDSCO Central Drugs Standard Control Organization (CDSCO), under MOHFW (Ministry of Health & Family Welfare), Government of…
GUIDELINE ON GOOD MANUFACTURING PRACTICES (GMP) IN PHARMA
GMP:- GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced…
VALIDATION OF STERILE PACKAGE INTEGRITY
Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may…
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