Process validation: An essential process in pharmaceutical industry

Brahmaiah Bonthagarala, Sandhya Ch., Pusuluri Dharani Lakshmi Sai, Konkipudi Venkata Sivaiah

Abstract


The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

Keywords


Process validation, Quality Assurance, Quality, Pharmaceutical industry

Full Text:

PDF

References


Aulton M.E, Pharmaceutics-The Science of Dosage Form Design. 2nded, Churchill Livingstone, Elsevier, 2006.

www.processvalidation.com

US Department of human and health services, Food and Drug Administration, Center for drug evaluation and research (CDER), Center for biologics evaluation and research (CBER), Center for veterinary medicine (CVM), Guidance for industry, Process Validation: General principles and practices, 2008.

Gupta G.D., Garg R., Aggarwal S., Guidelines on general principles of Validation: solid, liquid and sterile dosage forms, 6(1), 2008, 28-33.

FDA Guide on APIs, 1998, 48. PIC Guide, 1999, 32, Gold Sheet, 1996.

Chaitanyakumar G., Rout R.P., Ramtake S., Bhattacharya S., Process Validation, The Indian Pharmacist, 2005, 14-19.

Nash R.A., Alfred H.W., Pharmaceutical Process Validation, 3rd ed., Marcel Dekker, New York, 2003, 159-180.

Lambert J., Validation Guidelines for Pharmaceutical Dosage Forms. Healyh Canada/ Health Products and Food Branch Inspectorate, 2004, 7-15.

Sharp J.R., The Problems of Process Validation. ,

South African Guide to Good Manufacturing Practice, Medicines Control Council, Pretoria, 1996.

Guide to Inspections Validation of Cleaning Processes, US Food and Drug Administration, Washington Dc, 2005.

Satyabratajena, Arjun G, Anil kumarravipati N V, SatishkumarD,Vinod K R, David Umed A. Nikam et al., Current Pharma Research., Vol. 3(2), 2013, 824-835.

Banji Industrial Process Validation of SolidDosage Forms–An Overview International Journal of Pharmaceutical Sciences Review and Research, 3(2), 2010, 56-61.

Akers, J. “Simplifying and improving Process Validation”, Journal of Parenteral Science and Technology, 47(6), 2009, 281–284.

Agalloco J, "Validation: an unconventional review and reinvention". Validation: an unconventional review and reinvention, 49 (4), 2011, 175–179.

Elsie Jatto, Augustine O, “An Overview of pharmaceutical Validation and Process Controls in Drug Development”, Tropical journal of Pharmaceutical Research, 1(2), 2002, 115-122.

Robert A Nash and Alfred H, Pharmaceutical Process Validation , 129, 2003, 159-180.




DOI: http://dx.doi.org/10.7439/ijasr.v1i4.1781

Article Metrics

Metrics Loading ...

Metrics powered by PLOS ALM

Refbacks

  • There are currently no refbacks.


Copyright (c) 2015 International Journal of Advances in Scientific Research

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.