Abstract
The aim of this study was to describe application of molecular diagnostic tests based on nucleic acid amplification technologies (NAATs) in pharmaceutical product analysis. NAAT have become widely established in clinical microbiology laboratories in recent years, as well as in quality control (QC) laboratories for food testing, and lately introduced to the pharmaceutical QC laboratories. The number of available nucleic acid and gene amplification-based rapid microbiological methods has increased over the last few years, and for good reason. When compare to standard culture based methods, NAAT provide a rapid, an accurate and reliable means for detecting specific microorganisms of interest, especially in pharmaceutical dosage forms that are required to be free of objectionable or specified pharmacopeial organisms. This article discussed about the different types of nucleic acid amplification techniques and methods available to pharmaceutical microbiologists working on quality control of pharmaceutical products and develop some awareness among other pharmaceutical scientists. This review also highlights limitations of these methods applied in industrial setup.
Highlights
Deoxyribonucleic acid (DNA) contains the genetic information that controls the development of a microbial cell
This article discussed about the different types of nucleic acid amplification techniques and methods available to pharmaceutical microbiologists working on quality control of pharmaceutical products and develop some awareness among other pharmaceutical scientists
One of the technologies based on DNA analysis is the polymerase chain reaction (PCR).It was the first nucleic acid amplification method (NAAT) developed and until now has been the method of choice since its
Summary
Deoxyribonucleic acid (DNA) contains the genetic information that controls the development of a microbial cell. Identification of microbial contaminants provides important information to track contamination sources, implement proper corrective actions and understand microbial community composition (Jimenez, 2004; Cundell, 2006) For this purpose, there are a number of standard methods for identifying and detecting those indicator pathogens in pharmaceutical industry for quality evaluation of raw materials and finished products in different pharmacopoeias. There is a need in pharmaceutical industry to develop and perform a rapid procedure to detect the contaminants in timely manner to take immediate corrective action for contamination control and avoid huge production loss and product integrity Molecular methodologies such as Adenosine triphosphate (ATP) bioluminescence and polymerase chain reaction (PCR)-based assays provide rapid quality control analysis of cosmetic and pharmaceutical finished products and raw materials. This review discuss the advantages and issues of implementation of these methods in industrial setup
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