5^th International Summit on GMP, GCP & Quality Control August 12-13, 2016 Toronto, Ontario, Canada

Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S) are to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry. The FDA regulations and CFR are responsible for protecting and promoting public health through the regulation and supervision of all the products available in the market to ensure patient compliance. EU-GMP guidelines are needed to maintain the quality which is stricter when compared to WHO-GMP guidelines.

Regulatory Affairs Department is the backbone of Pharmaceutical Industry. It is the revenue generator for pharmaceutical Industry. The Regulatory Affairs Agencies explains expenditure spent on each drug annually is $850 million in US. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years India spends around $300 million, united kingdom $700 , Brazil $200 million , France $550, Italy $400 As per cabinet decision in June 2010 in Japan amended a new policy i.e., Health power strategy through “Life Innovation” and expenditure spent on each drug was $450 million.

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US FDA. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

The Global Active Pharmaceutical Ingredients Industry market research report introduces Active Pharmaceutical Ingredients basic information including definition, classification, application, industry chain structure, industry overview, policy analysis, and news analysis, etc.

For international and China market analysis, the report analyses Active Pharmaceutical Ingredients markets in China and other countries or regions by presenting research on global products of different types and applications, developments and trends of market, technology, and competitive landscape, and leading suppliers and countries’ 2010-2015 capacity, production, cost, price, Gross, production value, and gross margin. For leading suppliers, related information is listed as products, customers, application, capacity, market position, and company contact information, etc. 2015-2020 forecast on capacity, production, cost, price, Gross, production value, and gross margin for these markets are also included.

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.

The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

The role of ICH in designing GCP principles is to provide an ethical treatment to the subjects who are involved in the clinical trials. Conference on GCP is important because it is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including invitro studies. Pre-clinical trials assess the toxicity of a drug and examine its potential effects on the human body. These trials are conducted in-vitro which is required to proceed with clinical trials. Good laboratory practices should be followed for these pre-clinical trials.

The global clinical trial support services market is segmented based on phase of the clinical trial cycle such as preclinical studies, Phase I, Phase II, Phase III and Phase IV, by study design which includes observational studies and experimental studies, by the services provided such as patient recruitment management, assay Development, clinical research organizations, clinical trial site management and by geography. The geographical regions considered include North America, Europe, Latin America, Middle East Asia and Asia Pacific. The clinical trial support services regulation differs from region to region.

Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria that meets the requirements of the client or customer. A major aspect of quality control is the establishment of well-defined controls. These controls help standardize both production and reactions to quality issues. The role of Quality Impact Assessment & effectiveness checks is an essential operation of the pharmaceutical industry. To Perform Quality Control process of Project Management several quality control tools and software’s are required. Quality control also plays a major role in analytical method development so it would be great to attend the quality control summit.

Quality control is generally the responsibility of the operational units and quality is infused into the outputs and verified as they are being generated. Therefore, quality control is an integral part of the daily activities occurring within each operational unit.

Quality assurance is defined as a procedure or set of procedures intended to ensure that a product or service under development meets specified requirements. A quality assurance system is said to increase customer confidence and a company's credibility, to improve work processes and efficiency, and to enable a company to better compete with others. Quality assurance conferences aims at the need for Effective Internal and External Quality Assurance Auditing and it is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. Quality assurance testing is done by using software called Quality Metrics.

Quality assurance is focused on providing confidence that quality requirements are fulfilled. It includes all those planned and systemic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements.

The Quality Assurance Department establishes quality-assurance standards, systems, and processes, and measures, monitors, and ensures accuracy throughout the life of each research project. The Quality Assurance Department is involved in every phase of a study.

Validation means establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. The Major Phases of validation include Pre validation, Process Validation and Validation maintenance Phase.

Pharmaceutical Process Validation is the most important and recognized parameters of CGMPs. The requirement of process validation appears of the quality system (QS) regulation. The goal of a quality  system  is  to  consistently  produce products  that  are  fit  for  their  intended  use.

Traditional role of Contract manufacturing, also known as outsource manufacturing, is to produce one or more components of a final product in which a company relies on the skills of specialist manufacturers. Six Sigma is a long-term, forward-thinking initiative designed to fundamentally change the way corporations do business. It is first and foremost "a business process that enables companies to increase profits dramatically by streamlining operations, improving quality, and eliminating defects or mistakes in everything a company does. Aseptic/sterile production and injectable manufacturing processes require a significant investment in terms of expertise, equipment, process, technology and quality control.

The global market for pharmaceutical and biopharmaceutical contract manufacturing, research and packaging was $219.9 billion in 2012. This market is estimated to reach $242.2 billion in 2013 and $374.8 billion by 2018, a five-year compound annual growth rate (CAGR) of 9.1%.

Cold chain storage is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of pharmaceutical drugs. Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. Supply Chain integrity, enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products.

The Global Healthcare Supply Chain Industry 2015 Market Research Report provides a basic overview of the industry including definitions and classifications. The Healthcare Supply Chain market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

Development policies and plans are discussed as well as manufacturing processes and cost structures are also analysed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

Formulation development is to be done only after successful completion of pre-formulation studies. Optimization of existing formulations is required to create new products, Reduce costs, to capitalize on trends with greater profitability, novel formulations for improved delivery of existing dosage forms, to quickly recalculate formulations based on defined criteria, to create compliant products faster by using existing validated formulas. Product/Process optimization is the practice of making changes or adjustments to a process such as Conjoint Analysis, typically used in industrial process optimization.

Biopharmaceuticals is currently one of the fastest growing segments in the pharmaceutical industry. They have a vital use in the treatment of chronic diseases and also result in high profit margins for the drug developers. There are several therapeutic areas for which biopharmaceuticals are being investigated; these include oncology, metabolic disorders, viral infections, genetic disorders and immunological disorders. Biotherapeutics (both approved and under investigation) include monoclonal antibodies, cell therapies, clotting factors, cytokines, enzymes, hormones and vaccines. In fact, several antibody based therapies have already been approved across the globe.

The Quality control in typical food processing has a significant role in assuming a high quality, safe and nutritious food supply for the public, for their good health and for the economic benefits derived from trade of safe and high quality food. Quality control conference also plays a major role in food industry. Hazard Analysis & Critical Control Points (HACCP) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Food, Drug, and Cosmetic Act is a set of laws giving authority to the US-FDA to oversee the safety of food, drugs, and cosmetics. Cleaning, disinfection and hygiene should be strictly maintained in food industry.

The global market for equipment used in food processing and packaging was $21.7 billion in 2012 and $23 billion in 2013. This market is expected to reach $31.3 billion by 2018, rising at a five-year compound annual growth rate (CAGR) of 6.3% from 2013 to 2018.

Microbiological Assay is defined as the determination or estimation of concentration or potency of an antibiotic by means of measuring and comparing the area of zone of inhibition or turbidity produced by test substance with that of standard over a suitable microbe under standard conditions. FDA 510k Testing regulation is found in 21 CFR 807 includes information required in a 510(k). The 510(k) is not a form. Cleaning, disinfection and hygiene should be strictly maintained in Microbiology and Biotechnology.

The consumables, equipment and technology markets in the microbiology industry totalled nearly $7.7 billion in 2012. This total is expected to grow from $8.5 billion in 2013 to $11.4 billion in 2018, with a compound annual growth rate (CAGR) of 6.1% for the five-year period, 2013 to 2018.

The global market for media, sera and reagents used in biotechnology was valued at $2.3 billion in 2009, $2.5 billion in 2010 and is estimated to have reached nearly $2.8 billion at the end of 2011. The market is expected to reach $4.2 billion by 2016, a compound annual growth rate (CAGR) of 8.8%.

The use of GMP software systems in regulated industries is vital throughout all aspects of the manufacturing process. Quality management software provides a flexible and configurable platform for tracking and managing quality and compliance events to ensure that manufacturing activities are continually measured, monitored and improved upon.  In addition to managing all aspects of the audit process, GMP software solution manages the associated findings or observations, corrective and preventive actions (CAPAs), risk assessments, risk management and the analysis and approvals of changes. This software also manages deviations, process validation, complaint handling, manufacturing incidents, training records and more.

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Pharmaceutical industry is also called as “sleeping giant”. This industry is world’s largest industry in terms of revenues and investments. Its world’s recession proof sector and is highly organized and regulated. Indian pharmaceutical industry is third largest pharmaceutical market in terms of volume and fourteenth in terms of value. Currently, Indian pharma industry is growing at rate of 15% compound annual growth rate (Facts as per Market Line Advantage Report 2014). Different segments such as clinical research, contract research, contract manufacturing and project management are having very high demand now a day.