Volume No. :   6

Issue No. :  2

Year :  2016

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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A Brief Review on Quality by Design and Process Analytical Technology



Address:   Dipti G. Phadtare1*, Pawar Amol R2, Dr. R.B. Saudagar3
1Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy Anjaneri, Nasik, 422003
2Department of Quality Assurance Technique, R.G. Sapkal College of Pharmacy Anjaneri, Nasik, 422003
3Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy Anjaneri, Nasik, 422003
*Corresponding Author
DOI No: 10.5958/2231-5675.2016.00019.3

ABSTRACT:
In 21st century, PAT has become one of the new trends in the reform of the United States cGMP. In order to learn from foreign pharmaceutical quality control and production management experience, in this paper, the concept of PAT was introduced, the background of drug production PAT and its significance, the development trends of domestic pharmaceutical production PAT were reviewed. Process analytical technology (PAT) has been defined as a mechanism to design, analyze and control pharmaceutical manufacturing processes through measurement of critical process parameters which affect critical quality attributes. PAT checks the quality of raw material attributes both physically and chemically (i.e. at off-line, on-line, in-line). The first steps in an Analytical Quality-by-Design (AQbD) method development include understanding the analysis needs (e.g., purpose, specificity, sensitivity, cycle time, on-line/off-line, qualitative/quantitative, accuracy, precision) and selection of the technique that will meet these criteria. One set of analytical tools applied during the development and scale-up of drug substances and dosage forms include in-situ analytics, chemometrics and modelling i.e., Process Analytical Technology (PAT) tools.
KEYWORDS:
PAT, Pharmaceutical, Manufacturing process, Quality assurance. Drug Quality Control Process analytical technology, Quality by design
Cite:
Dipti G. Phadtare, Pawar Amol R, R.B. Saudagar. A Brief Review on Quality by Design and Process Analytical Technology. Asian J. Pharm. Ana. 2016; 6(2): 122-130.
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