SOP for Incident Handling in Pharmaceutical Industry: PharmaState
1. Objective: To lay down a procedure for handling of incidents. Scope: This procedure is applicable for accidental and untoward events occurring in factory premises. Incidents…
Category: GMP & Guidelines
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…
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…
PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme]- Guidelines & Links
All Reference Category Section AIDE MEMOIRE ON ASSESSMENT OF QUALITY RISK MANAGEMENT (QRM) IMPLEMENTATION PI 038-1 Documents for Inspectors Aide-Memoires AIDE…
Bacteriology: Specimen Collection, Transport & Processing
A. Blood: (1). Collection and transport Purpose: To reduce blood culture contamination rate, collection may be improved by taking the following precautions. Note: This is…
REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF MEDICAL DEVICES
(A). GENERAL REQUIREMENTS: (i) Location and surroundings: The factory building(s) shall be located in a sanitary place and hygienic conditions shall be maintained in the…
SCHEDULE M-I
A. Requirements of factory premises for manufacture of Homoeopathic preparations: (1). Location and surroundings: The factory shall be situated in a place which shall not…
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