Ashish et al., ARPB, 2014; Vol 4 (II) ISSN 2250 ISSN 2250 ISSN 2250 ISSN 2250-0774 0774 0774 0774 (RE (RE (RE (REVIEW VIEW VIEW VIEW ARTICLE) ARTICLE) ARTICLE) ARTICLE) 655 | Page www.arpb.info TOTAL QUALITY MANAGEMENT OF PHARMACEUTICALS: RECENT APPROACHES AND ADVANCEMENTS TOTAL QUALITY MANAGEMENT OF PHARMACEUTICALS: RECENT APPROACHES AND ADVANCEMENTS TOTAL QUALITY MANAGEMENT OF PHARMACEUTICALS: RECENT APPROACHES AND ADVANCEMENTS TOTAL QUALITY MANAGEMENT OF PHARMACEUTICALS: RECENT APPROACHES AND ADVANCEMENTS S. Bhandari . Bhandari . Bhandari . Bhandari and and and and *A *A *A *A. Baldi Baldi Baldi Baldi Department of Quality Assurance, I.S.F. College of Pharmacy, Moga, Punjab Department of Quality Assurance, I.S.F. College of Pharmacy, Moga, Punjab Department of Quality Assurance, I.S.F. College of Pharmacy, Moga, Punjab Department of Quality Assurance, I.S.F. College of Pharmacy, Moga, Punjab – 142001 142001 142001 142001 Received on Received on Received on Received on 11 11 11 11/04 04 04 04/2014 /2014 /2014 /2014 Revi evi evi evised on 22 sed on 22 sed on 22 sed on 22/04/2014 /2014 /2014 /2014 Accepted on 01 Accepted on 01 Accepted on 01 Accepted on 01/05/201 /201 /201 /2014 ABSTRACT ABSTRACT ABSTRACT ABSTRACT : : : : Quality of pharmaceuticals has always been a prime area of concern for regulatory agencies across the globe in order to facilitate production of medicines without batch to batch variations and hence maintaining the same therapeutic effectiveness with the advent of total quality management a new vista has opened for assured quality of pharmaceuticals. Total quality management being a multidimensional approach essentially requires adherence to quality practices in all areas of pharmaceutical production. Application of various approaches and practices viz. quality by design, quality risk management, six sigma approach along with following regulatory guidelines in all facets may lead to practical realization of this concept. This article presents a brief review of existing industrial practices of total quality management with special emphasis on recent advancements in online production monitoring, sophisticated analytical tools and anti-counterfeiting technologies. Keywords: Keywords: Keywords: Keywords: Counterfeit drugs, Good manufacturing practices, Lean manufacturing, Quality, Quality by design, Quality risk management. INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION Pharmaceutical industry is a very vital segment of the our health care system, which deals with manufacturing and marketing of pharmaceuticals and biological products and medicinal devices, used for the diagnosis and treatment of diseases as well as conducts research for development of new products for human welfare. So maintenance of quality is very necessary to prevent health hazard as many pharmaceutical products are life saving products, so if products are not of appropriate quality then they may result in severe adverse effects or even death of the consumer or patient. Regulatory agencies of various countries noted that there are deficiencies in conventional quality management systems, so they start adopting this approach called Total Quality Management (TQM). This concept of TQM is very important for maintenance and improvement of quality and for prevention of defects 1 . Initially concept of total quality control was used that quality was assured just on basis of quality control parameters quality was assured. But this concept of TQM involves building quality in a pharmaceutical product as it involve complete records such as standard operating procedures for every step, validation records, master formula records and batch production records etc. This review includes information about quality, quality management, current status and need of TQM. This article describes TQM as multifaceted approach for quality management of pharmaceuticals by utilizing various quality management approaches such as quality by design, good manufacturing practices, quality risk management etc. leading to high quality products. Quality Quality Quality Quality The term quality is used very commonly, this term looks to be very easy but it is difficult to define quality precisely. * Corresponding Author: Corresponding Author: Corresponding Author: Corresponding Author: Dr. Ashish Baldi Dr. Ashish Baldi Dr. Ashish Baldi Dr. Ashish Baldi Principal and Professor, I.S.F. College of Pharmacy, G.T. Road, N.H. 95, Moga (Punjab) 142 001 Email: baldiashish@gmail.com Telephone: +91-1636-324200 Fax: +91-1636-239515