Pharma Regulations & Guidelines-India, Easy Access Links

(1). Regulations & Guidelines:              CDSCO    Central Drugs Standard Control Organization (CDSCO), under…

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…

Bacteriology: Specimen Collection, Transport & Processing

A. Blood: (1). Collection and transport Purpose: To reduce blood culture contamination rate, collection may be…

Standard Operating Procedures (SOPs)- Bacteriology

General Guidelines Introduction: This is a comprehensive standard operative procedure manual for all types of specimens…

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…

Guidance for Industry: Microbiology Laboratories

This guideline is intended to provide general guidance on the interpretation of the 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…

SOP FOR CLEANING PROCEDURE OF GENERAL MICROBIOLOGICAL TESTING AREA

1.0 OBJECTIVE:- The objective of this SOP is to lay down a procedure for cleaning procedure…

SOP FOR MICROBIOLOGICAL ASSAY FOR DETERMINING THE POTENCY OF THE DRUG

1.0 OBJECTIVE : To laid down procedure for Microbiological assay for determining the potency of the…

OPERATOR PROTECTION FACTOR (OPF) IN ASEPTIC FACILITY

Introduction:- Class II safety cabinets are designed to control airborne contamination of the product and reduce…