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…
Category: Microbiology
Specimen Collection, Transport and Processing: Bacteriology
F. Pus Purpose: To isolate and identify bacterial etiological agent(s) in deep-seated pus/wound specimens. Specimen collection: Preferably collect specimen prior to initiation of therapy and only…
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…
Standard Operating Procedures (SOPs)- Bacteriology
General Guidelines Introduction: This is a comprehensive standard operative procedure manual for all types of specimens received in a clinical bacteriology diagnostic laboratory serving a…
SOP on Entry and Exit procedure for Microbiology Laboratory
This SOP is applicable for Entry and exit procedure for Microbiology Laboratory in Quality Control Laboratory of pharmaceuticals formulation plant. Procedure: Microbiology laboratory-General Areas: Microbiology laboratory…
Guidance for Industry: Microbiology Laboratories
This guideline is intended to provide general guidance on the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to…
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…
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…
SOP FOR MICROBIOLOGICAL ASSAY FOR DETERMINING THE POTENCY OF THE DRUG 1
1.0 OBJECTIVE : To laid down procedure for Microbiological assay for determining the potency of the drug. 2.0 SCOPE : This SOP is applicable for…
OPERATOR PROTECTION FACTOR (OPF) IN ASEPTIC FACILITY
Introduction:- Class II safety cabinets are designed to control airborne contamination of the product and reduce the exposure of the operator to any airborne contamination…
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