Scientific Program | Pharmaceutical Conferences |2015-2016

Conference Series Ltd invites all the participants across the globe to attend 4^th International Summit on GMP, GCP & Quality Control Hyderabad, India.

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Track 5: Good Clinical Practices & Good Laboratory Practices
Track 10: Storage, Distribution, Transportation

Session Introduction

Prakash V Diwan

Anurag Group of institutions, India

Title: Good laboratory Practices:A wake up call for pharmaceutical industries

Biography:

Prakash V Diwan, male Pharmacologist, obtained his PhD from Post Graduate Institute of Medical Education and Research, India in 1980. He served as Assistant Professor in J N Medical College, India and later joined the research and development organization, Indian Institute of Chemical Technology (CSIR) in 1983-2007. He was nominated as the Founder Director, NIPER, Hyderabad in the year 2007. He was awarded with many national awards in the field of pharmacology. He is a Fellow of Royal Society of London (FRSC). To his credit, he has over 200 research publication in national and international journals with an H index 36.00. He has been honoured as a Fellow of Indian Pharmacological Society and Fellow of Andhra Pradesh Academy of Sciences and Fellow of Indian Pharmaceutical association. He has been a Member in Indian Pharmacopeia Commission, Scientific Consultant for various reputed pharmaceutical industries. His contributions are in the field of pharmacology, nanotechnology, clinical researches are laudable. Presently, he holds the responsible positions as Director and Research Scientist in Academia & Research and Development Institutions. He is also a Visiting Scientist at Dr Prabhakar Kore Basic Science Research Center, Belgaum, Karnataka. He has delivered guest lectures and keynote addresses in India and abroad on various challenging areas.

Abstract:

The globe is marching towards perfection. Basically, GLP is a regulation not a guideline. Industry needs greater performance with minimum investments, which is possible only if you adopt GLP. Consumer focuses on and expects quality for a good price. The thalidomide tragedy has opened the new vision for the regulations and has cautioned the world, the extent of toxicity by the drugs. The objective of “Good Laboratory Practice” (GLP) was brought to prevent such a disasters and also poor planning and execution and manipulation of the raw data as manipulation would promote or accelerate approval. GLP aims at: • Securing efforts to generate high quality and reliable data pertaining to protection of man and the environment against various sorts of chemicals and without prejudice against explanation and evaluation of study’s results, • Mutual acceptance of data (MAD) of studies among countries so as to reduce a number of animal tests and trim costs. Good Laboratory Practice (GLP) is a quality system laying down organization, procedures and requirements to plan, implement, document, archive and transfer of non-clinical studies and their results. GLP principles have been developed in the framework of OECD. GLP is the corner stone of the laboratory based activities in any organization. It is not a luxury but essential for the professional laboratories. The GLP assures the quality and integrity and experiments done under GLP are acceptable to countries covered under OECD memberships worldwide. It has the standard operating procedure which is the brain behind the performance which makes it as a system based and not individual based performance. The GLP is a team work consisting of Management, Study Directors, Performer, Quality manager, Archivist and their jobs are well defined. The Study Director is a blue-eyed boy of the management and holds the key of GLP. The management provides resources, Study Director performs and quality assurance units assures the quality and integrity of the study and Archivist preserves the all materials such as study plans, training records, amendments , deviations samples, raw data, etc., in his custody. The documentation is of prime importance. If not documented meaning is not done. There no dearth to prove excellence and meaning well planned is well executed to the satisfaction of sponsor. We need to answer the following: • Do we need GLP? • Can we achieve excellence? • Can we guarantee quality and integrity? • Is it a luxury? • Does it involve risk? • Are there any disadvantages? • GLP is obviously so crucial to modern laboratory operations, but most importantly because good laboratory practice is an essential ingredient for any professional scientist.

Pooja Roy

Vydehi Institute of Medical Sciences and Research Centre, India

Title: Good clinical Practice (GCP) and Declaration of Helsinki

Time : 14:00-14:25

Biography:

Pooja Roy completed her MBBS from Dr B R Ambedkar Medical College, Bangalore and her MD in Pharmacology from Vydehi Institute of Medical Sciences, Bangalore. Currently she is working as an Assistant Professor in Bangalore. She takes active interest in all spheres of the subject and is actively involved in teaching medical students and has several oral papers and poster presentations to her credit.

Abstract:

The concept of ‘good physician’ is evident by the Hippocratic Oath (460 BC). In the United States, the first landmark in the regulation of drugs was the Food and Drugs Act of 1906. In 1947, the Nuremberg Code was created as a result of the unethical and horrific experiments carried out during World War II at Nazi war camps by German physicians. However, since 1964, the Declaration of Helsinki has stood as one of the world’s most authoritative statements on ethical standards for human research. The Declaration has undergone six major revisions, most recently in October, 2008. For many years the USFDA has required that foreign clinical studies supporting applications for drug licensure comply with the Declaration. However, on Oct 27, 2008, the FDA formally discontinued its reliance on the Declaration and substituted the International Conference on Harmonization’s Guideline for Good Clinical Practice (GCP). Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, and monitoring, auditing, recording, analyses and reporting of clinical trials. GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected and protected. However, several authors have criticized GCP and compared between GCP and the Declaration of Helsinki from time to time. It has been put forward that at a time when the volume of overseas trials is increasing, the FDA’s new policy is troubling. Several requirements in latest revision of Declaration of Helsinki have been highlighted which are absent in GCP.

Young Researchers Forum(YRF)

India is a hub of global clinical trials and a destination for drug discovery & development. However, whether patients in India receive safe drugs or not is still very much in question. Rapid induction of high tech pharma products in the market throw up the challenges of monitoring Adverse Drug Reaction (ADRs). The complete safety data commonly is captured through Pharmacovigilance. True challenge lies in recognizing the importance & applying current 3G system in pharmacy, i.e., Good Manufacturing Practices, Good Laboratory Practices & Good Pharmacy Practices with vigilance in order to improve public health. This article mainly highlights on Medwatch program & its goal and patient safety. It mainly focuses on adverse effect reporting & producing new safety information to patients. Medwatch is the FDA reporting system for an adverse effect, aimed to detect safety hazard signals for medical products. It deals with pre-market review and approval & post-market monitoring for safety. It also determines the benefit and limitation of clinical trials. It focuses on adverse event monitoring and new drug safety problems. Approaches like–Yellow Card Scheme for ADR reporting in the UK should also are encouraged worldwide to identifying new information about hazards associated with medicines. Even, mandatory reporting is required by manufacturer to submit the reports to the healthcare provider & post-authorization safety experience should be conducted to ensure the benefits of use of drugs. Thus, it generates a great way towards a safe medical practice.

Vineela Nekkanti

Rajiv Gandhi University of Health Sciences, India

Biography:

Abstract:

Workshop

Session Introduction

Ravi Kumar Tummalacharla

Cleanrooms Containments, India

Title: How to prevent outbreaks in endemic countries?

Time : 10:00-11:00

Biography:

Ravi Kumar Tummalachalra is a Graduate Mechanical Engineer. Expert in Design& construction of Bio-Containment projects (BSL-3 Ag, BSL-3, BSL-2 facilities), Cleanrooms, HVAC systems. He has 16 yrs of experience on Cleanrooms, Biocontainment’s, Vivariums (Animal facilities), Eco toxicology labs, Microbiology, Virology, Bacteriology, Analytical, Instrumentation labs. In the past worked for Bharat Biotech, Biovet and Voltas ltd. Founder and CEO of Cleanrooms Containments since 2011. Presented few topics on Bio-Containments, Cleanrooms on various national and international seminars. Exclusively working on Cleanrooms and Bio-Containments. Going to present another talk at IVBWG at Geelong-Australia on Nov 3rd 2015. Member of ABSA (American Biological Safety Association), ASHRAE (American Society for Heating, Refrigeration& Air-Conditioning Engineers), Society for bio-Safety of India, CCSI (Contamination Control Society of India). Actively involved in organizing ASHRAE programs.

Abstract:

The presentation shall give an over view of Bio-Containments, CDC/NIH guidelines, how to select suitable containment, how to stop outbreaks by developing effective, energy efficient, safe new research and manufacturing facilities to prevent outbreaks. Few points on Bio-security also discussed. Presentation shall cover methods and technologies implemented globally for Bio-containments, Research facilities, safety measures to follow while handling infectious organisms. Constructional features of these facilities, some typical layouts, material of construction of these facilities, HVAC requirements, and various primary, secondary and tertiary containment methods are discussed in detail. There are Life science research Bio-containments and Pharmaceutical containments also and both are slightly different. It is explained appropriately. What are the adverse effects of outbreaks, economic loss to nation are also discussed. India is endemic to many infectious diseases. DBT& DST formed some Bio-Safety guidelines for India, but there is a necessity to form a committee to develop and release complete guidelines for the nation. A Govt. certifying body to certify the certifying companies. These companies in turn to certify the bio-containments all over India after construction of new facilities and for re-qualification every year. Bio-containments are for Bio-safety, they are different from Cleanrooms. Major consideration shall be for Personnel and Environmental safety rather than product safety in bio-containment facilities.

Special Session

Session Introduction

Peter D Smith

Parexel International, USA

Title: The Importance of Proper Change Management

Time : 12:15-13:10

Biography:

Peter D Smith joined PAREXEL (then KMI) in 1994 following a 22-year FDA career and works with clients in the pharmaceutical and biologics industry worldwide. At the FDA, he was an Investigator, specializing in pharmaceutical GMP/GCP and medical device inspections, later serving in FDA Headquarters where he managed the FDA’s Foreign Drug Inspection Program. He has primary expertise in GMP for Active Pharmaceutical Ingredients, sterile and non-sterile dosage forms, management of Pre-Approval Inspections, GMP/Quality Systems and FDA regulatory issues. He holds a BS in Biology from Roger Williams University in Rhode Island. He is a Member of ISPE and PDA, and an Associate Adjunct Professor at the University of Rhode Island, College of Pharmacy.

Abstract:

Change Management in the regulated pharmaceutical, biologic, and medical device industries is a critical element of the Quality System. Changes occur at every phase of product lifecycle from development to product discontinuation. Changes may be critical, such as a manufacturing process change or relatively minor, such as addition of a new sampling port on a process water system. In all cases, all changes must be documented and evaluated for risk and potential impact on product quality. All changes must be evaluated by the Quality Unit and effectiveness checks are required after implementation to ensure the change achieved the intended affect. There must be assurance that no unintended consequence has occurred. Changes must be managed through a robust systematic process in order to assure compliance with regulatory requirements. Virtually all regulators require a change management procedure or program. An integral part of ICH Q10, Pharmaceutical Quality System, is a Change Management System. Regulators including the U.S. FDA and the European Medicines Agency have adopted ICH Q10 to support their GMP regulations. Additionally, the specific GMP requirements enforced by the regulators refer to the control and management of changes. This presentation will expand on the regulatory requirements, expectations by the regulators, discuss common change control program pitfalls, and discuss the elements of a robust change management system. In all cases, all changes must be documented and evaluated for risk and potential impact on product quality. All changes must be evaluated by the Quality Unit and effectiveness checks are required after implementation to ensure the change achieved the intended affect. There must be assurance that no unintended consequence has occurred. Changes must be managed through a robust systematic process in order to assure compliance with regulatory requirements. Virtually all regulators require a change management procedure or program. An integral part of ICH Q10, Pharmaceutical Quality System, is a Change Management System. Regulators including the U.S. FDA and the European Medicines Agency have adopted ICH Q10 to support their GMP regulations. Additionally, the specific GMP requirements enforced by the regulators refer to the control and management of changes. This presentation will expand on the regulatory requirements, expectations by the regulators, discuss common change control program pitfalls, and discuss the elements of a robust change management system.

Track 1: Good Manufacturing Practices: The Gap within
Track 2: Current Regulations and Quality Standards
Track 3: Current GMP Guidelines (cGMP)
Track 4: The Role of

Session Introduction

Pradeep K Jha

IIT Kharagpur, India

Title: Entropy in Good Manufacturing Practices driven innovative quality tool for pharmaceutical industry: New paradigm approach for manufacturing excellence and quality standards

Time : 14:00-14:25

Biography:

Pradeep K Jha is a Senior Research Scientist at IIT Kharagpur and Visiting Faculty in JP Business School Meerut. He has completed MSc (Med Chem), MSc (TQM), PhD in Healthcare Management from Gautam Buddha Technical University Lucknow and EUROMA Summer Post-Doctoral Training in Global Operation Management in Hungary. He is Consultant and Member of IcubedG Ideas Pvt. Ltd. and SG ArtHeart Private Limited, respectively. He is Member of WABT France, EUROMA, ISSRF, SAI Professional Societies and Referee of several science and management journals. He has published 15 papers in international journals and presented more than seventy papers at national and international conferences.

Abstract:

It has been customary to implement Good Manufacturing Practices (GMP) in pharmaceutical organizations as a systematic and comprehensive quality approach and sometimes by regulatory enforcement. In this scenario, determination of the obvious entropy/disorder arising during the implementation has not been taken care of yet. Therefore, this paper gives the basis for applying query and visual perception of GMP system driven visualization approach, particularly the Laplace equation, to the determination of disorder and deviation pattern inside the GMP system applied in the organization. In this study, a three-dimensional mesh approached with raw and intermediate input handled under GMP parameter is considered to produce high quality products with minimum entropy by adding the analogy wise different GMP parameters and process variables with Gauss Seidel iteration and thus producing visual picture of the entire system. The approximation involved in applying the concept in sterile drug manufacturing pilot plant. Using numerical technique and computer program, the Gauss Seidel iteration equations have been solved with appropriate GMP parameter and process variable. The result indicates that deviations vary over the GMP compliant system and that the process entropy affects the totality of disorderness. Implementation in GMP complaint drug development pilot plant confirm that the new method provides optimal manufacturing maintaining GMP and high product quality through the visual representation of the entire system and activity to bring into notice the deviations.

Uma Vasireddy

Kakatiya Institute of Pharmaceutical Sciences, India

Title: Comparison of Guidelines of Indian GMP with WHO GMP

Time : 14:25-14:50

Biography:

Uma Vasireddy has completed her M.Pharm from UCPS,Kakatiya University campus and Ph.D. from JNTU Hyderabad in Pharmaceutical Sciences. She is the Principal of Kakatiya Institute of Pharmaceutical Sciences,Kakatiya University and also Honorary Coordinator for Pharmaceuticals Export Promotion Council of India (PHARMEXCIL). She has 30 years of experience in Manufacturing, Clinical Research and also grew to the heights of Vice President in the Abdul Kallam Raju Heart Stent manufacturing division. The highest position held was Dean in Academia and closely associated with several Academic institutions as a guide for Student Research Projects. She presented and attended several national and international conferences. One of her scholastic achievements as a Professor of an Academic Institute is setting up of a Industry Institution Innovation - III Cell, under - DST, Government of India. To her credit, she has more than 50 publications in reputed National and International journals.

Abstract:

Good Manufacturing Practice is a set of principles and procedures for ensuring that pharmaceutical products are consistently produced under controlled conditions to achieve quality standards appropriate to their intended use. India and many countries have formulated guidelines corresponding to their legislative requirements which are governed by regulatory bodies. World Health Organization Good Manufacturing Practices certification is a necessary condition to participate in the international commerce for market authorization. A comparison of guidelines of Indian Good Manufacturing Practices with World Health Organization Good Manufacturing Practices for pharmaceutical products was done. In India under the Drugs and Cosmetics Act, 1940 and Rules 1945 there under prescribes Good Manufacturing Practices under Schedule M and they are to be interpreted with many other conditions laid down under various rules. An elaborate explanation on Schedule M was given which are relevant in the Indian context. Schedule M covers all aspects of production from the raw materials, premises and equipment to the training and personal hygiene of staff. Quality is to be built into each batch of product during all stages of the manufacturing process. Every time a product is made there must be a written procedure and documented proof is essential for each process that could affect the quality of the finished product. On comparison of regulations of Indian Good Manufacturing Practices under the Schedule M and World Health Organization Good Manufacturing Practices it was noticed that Indian Good Manufacturing Practices is found to be more stringent than the World Health Organization Good Manufacturing Practices Guidelines. Compliance and updating of Indian Good Manufacturing Practices will encourage in boosting exports of Indian pharmaceutical Industry by keeping the spirit of ‘Make in India’.

Subhasish Biswas

West Bengal University of Animal Fishery Sciences, India

Biography:

Gannu Praveen Kumar has been a Professor and, now, is the Principal in Sahasra Institute of Pharmaceutical Sciences since April 2014. He graduated from H K Eâ€™s Society College of Pharmacy, Gulbarga University in 1997, completed Post-Graduation from BITS, Pilani in 1999 and PhD from UCPSC, Kakatiya University in 2009. He worked as Assistant Professor for Vaagdevi College of Pharmacy, from 1999-2005, as Associate Professor for SR College of Pharmacy from 2008-2010, as Professor and HOD for Talla Padmavathi College of Pharmacy from 2010-2011 and as Professor & HOD for St. Peterâ€™s Institute of Pharmaceutical Sciences from 2011 to 2014. In 2009, he was appointed as an External Examiner for Post-Graduation and has guided 30 MPharm students. He has published in both national and international journals and compiled few chapters for text books. He received Gem of India Award in the year 1999. He was selected as a Best Academician of Vaagdevi College of Pharmacy in 2002 and of Talla Padmavathi College of Pharmacy in 2011. He is an Advisor for few pharmaceutical companies. He visited foreign countries like London, Dubai, Singapore, Malaysia and Spain as Invited Speaker.

Abstract:

The term globalization was first used in 1940s. The political economist George Modelski reintroduced the term in 1972 to describe the impact of multinational cooperation on economic relations within and between countries. The concept of globalization means that countries and regions of the world come together toward policies and regulations. In other words, it is a global network where there is a better interconnection between different countries and regions. It dismantles the state barriers to trade, economic, social and politics to enhance their growth. Globalization of Good Manufacturing Practices (GMP) helps in removing the trade barriers, improve technical cooperation, improvise cost saving of testing & evaluation processes, support free market competition and information transformation. So, compliance with GMP is a necessary condition for marketing authorization because domestic and foreign producers of pharmaceutical companies cannot sell or market their drugs around the globe. While GMP compliance has not been universally adopted in the developing world, governments in less developed countries are under pressure to comply with GMP requirements when granting marketing authorizations to domestic companies and most of them have developed variety of strategies to ensure that developing countries adopt the rules. GMP requirements require major investment in upgrading manufacturing facilities and this has implications for local producers. An interesting empirical question is the impact of these changes on local markets, access to and affordability of medicines in developing countries. More importantly, pharmaceutical excipients are no longer inert materials but are effective and able to improve the characteristics of the product quality, stability, functionality, safety, solubility and acceptance of patients. Therefore, globalization of medicines supply, also enhance the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. Globalization of the medicine market motivates manufacturers especially in the developed countries to consider various pharmacopeia requirements to facilitate export of their products. In fact, globalization of the finished products supply chain elevated gradually even in the developed countries. Moreover, the current situation needs globalization of the excipients supply chain as well to improve the GMP compliance and appropriately counteract counterfeit and substandard ingredients besides lowering of the pharmaceutical excipients cost in addition to that traceability and contamination control are fundamental elements and should be revised by suppliers. Thus, Globalized Good Manufacturing Practice requirements for pharmaceutical Industries are crucial to face the impact of globalized medicines supply. This study highlights the impact of globalization of good manufacturing practice (GMP) requirements for Pharmaceutical Companies.

Vaishali P Nagulwar

Government College of Pharmacy, India

Title: Quality management systems

Time : 15:55-16:20

Biography:

Vaishali P Nagulwar is currently working as an Assistant Professor (Department of Pharmaceutical Chemistry) in Government College of Pharmacy, Amravati. She has her qualification from Department of Pharmaceutical Sciences; RTM Nagpur University, Nagpur and PhD from Sharad Pawar College of Pharmacy, Nagpur. She has published till date 23 research papers in national and international journals and presented about 35 research papers in various conferences. She is now associated with UG, PG and PhD assignments.

Abstract:

Quality management systems are the integral aspect of Quality Standards required to achieve the goal of providing quality product or service to the society. ANSI/ISO/ASQ Q9001-2000 and ANSI/ISO/ASQ Q9004-2000 describing the guidelines for the requirements and performance improvement, has come up with tremendous change in the scenario of manufacturing as well as in the service sectors. Various modules of Quality basics like Quality benefits, Evolution of Quality, Total Quality Management, Process Management, Quality Tools and Quality Deployment are needed to be understood and followed which can lead to a better managerial control in any organization. Application of these modules results in providing good quality products with maximum profit and minimum loss. Quality as well as safety is now important elements for the customers and hence to gain their faith, trust and goodwill, companies should try to adopt the Quality Management Systems whereby improved products/services and processes will reflect profitability to them for long term. As these quality modules links customers, employees, organizations, suppliers and society together, thus helps in building an improved communications, streamlined work processes, job satisfaction, happier customers, strong customer relationships, economic growth and stability. Customer relationships, continuous improvement and company- wide participation are three important keys of total quality management which works in a fine manner to improve the efficiency and benefits of any organization. Globalization in every sector has now made it mandatory to understand the concepts of quality management systems to every organization if it has to survive in this world of tremendous competition.

Abha Doshi

MET Institute of Pharmacy, India

Title: Current GMP guidelines

Time : 16:20-16:45

Biography:

Abstract:

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. These are the system to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process every time a product is made. Many countries have formulated their own requirements for GMP based on WHO GMP guidelines. GMP is referred to as cGMP mostly in United States of America which refers to current good manufacturing practice. The current GMP guidelines are formulated with continuous improvement and addition in the recent past. These guidelines provide minimum requirement that a pharmaceutical or a food product manufacture must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. These requirements concern methods, equipment or testing which are used for the production, processing, packaging and/or storage of drugs. This ensures that medicine products fulfil the necessary quality criteria. Good quality must be built-in during the manufacturing process; it cannot be tested into the product after wards. Current GMP is designed to ensure that mistakes do not occur again. Systems and equipment which are used to prevent contamination mix ups and error, which may have been top of the line 20 years ago, may be less than adequate by today’s standard. There has to be continuous improvement and updating in the systems, procedures and software’s from time to time by the company. It will be dealt in detail in the talk.

Shashi Kumar Yadav

Sri Indu Institute of Pharmacy, India

Title: Comparison of regulatory requirements for marketing authorization of biologics in United States and European Union

Time : 16:45-17:10

Abstract:

India has a long tradition of use on herbal medicines and has very rich diversity of medicinal plants. The increasing demand for herbal products has forced the overexploitation and unscientific collection of natural populations of medicinal plants from the forests rendering several species to vulnerable state. Any threat to these valuable resources will not only jeopardize the health of millions of people, but will also affect the livelihoods of resource poor collectors/farmers and communities that depend on them. Since the medicinal plants and their plant parts are used in raw form in the traditional medicines, the important aspects which govern the quality of the drug at initial level are the correct identification of species, optimum stage of harvest and primary processing. This paper gives a brief account on Good collection/harvesting practices of some important medicinal plants like i.e., Aonla (Phyllanthus emblica), Baividang (Embelia tsjeriam-cottam), Baheda (Terminalia bellerica), Gudmar (Gymnema sylvestre), Sarpagandha (Rauvolfia serpentina) and Kalmegh (Andrographis paniculata). Adoption of sustainable harvesting practices at right time of harvest showed positive impact on resource conservation, socio-economic status of community, quality of produce, economic returns and marketing. It is evident from our study that the medicinal plants collected at right time of maturity following sustainable harvesting practices possess better quality in terms of active ingredients concentration. Sustainable harvesting technologies have been standardized for only few species, which are used for large-scale production of phyto-pharmaceuticals. But there is an urgent need to develop suitable technologies for other important plants used for the manufacture of drugs. The technique should be simple which could be easily understood and adopted by the collectors. This will help in avoiding indiscriminate extraction of plant, supply of good quality material to the consumer and enabling the collector in getting a better price of the produce. Sustainable harvest system and effective community managed regulatory mechanism shall be put in place for harvesting of medicinal plants from the wild.

Track 6:Quality Control
Track 7:Quality Assurance
Track 8:Validation
Track 9:Contract & Sterile/Aseptic Manufacturing
Track 11:Formulation Development
Track 12:GMP in Food Industry
Track 13:GMP in Microbiology and Biotechnology

In this presentation, the focus will be on systematically discussing the methods adopted and their application in quality control and standardization of herbal drugs. For this purpose a comprehensive literature review was performed on recent articles related to the core theme of the presentation from the current bibliographic, abstracting and indexing services including PubMed. It is a fact that herbal medicines of a kind planted or in the wild usually differ from each other greatly based on their storage under different environmental conditions. Even the quality parameters of the same batch of herbal medicine may vary significantly. Therefore, it is of utmost significance to ensure the quality of herbal medicines through effective and convenient analytical methods. The quality control of herbal medicines generally involves three steps. The first is false and true identification, the second is to distinguish originating regions of herbs, and the third is quality evaluation. The false and true identification aims to distinguish the species by means of many qualitative analytical methods. The qualities of herbs are closely related to their producing areas. For this reason, the determination of producing regions is critical. The quality of herbs depends on the environments, collecting time of these products and the storage conditions. The quality control analytical techniques have undergone a paradigm shift of sorts since in the recent years transcending from the typical estimates from the morphology, microscopic feature identifications to the physical and chemical properties based on the major constituent identification to almost all components being identification based on utilization of the fingerprint spectra and allied chromatographic techniques.