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45-460: There are thousands of biomanufacturing products on the market today. Some examples of general classes are listed below: A partial listing of unit operations utilized during biomanufacturing includes the following: Equipment and facility requirements are dictated by the product(s) being manufactured. Process equipment is typically constructed of stainless steel or plastic. Stainless steel equipment can be cleaned and reused. Some plastic equipment

90-478: A "reasonable time". Courts have held that any time the firm is open for business is a reasonable time for an inspection. Other good-practice systems, along the same lines as GMP, exist: Collectively, these and other good-practice requirements are referred to as " GxP " requirements, all of which follow similar philosophies. Other examples include good guidance practice and good tissue practice. Quality management system A quality management system ( QMS )

135-537: A QMS addressing the principles and processes surrounding the design , development , and delivery of a general product or service . Organizations can participate in a continuing certification process to ISO 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e. planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis ( FMEA ). ISO 9000:2005 provides information on

180-537: A deeper insight into employee behaviors that impact product quality. In its Guidance for Industry "Data Integrity and Compliance With Drug CGMP" US-FDA states “it is the role of management with executive responsibility to create a quality culture where employees understand that [[data integrity ]] is an organizational core value and employees are encouraged to identify and promptly report data integrity issues.” Australia's Therapeutic Goods Administration has said that recent data integrity failures have raised questions about

225-400: A different set of CGMP requirements have applied to all manufacturers of dietary supplements , with additional supporting guidance issued in 2010. Additionally, in the U.S., medical device manufacturers must follow what are called "quality system regulations" which are deliberately harmonized with ISO requirements, not necessarily CGMPs. The World Health Organization (WHO) version of GMP

270-574: A few basic principles: Good manufacturing practice is recommended with the goal of safeguarding the health of consumers and patients as well as producing quality products. In the United States, a food or drug may be deemed "adulterated" if it has passed all of the specifications tests but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. GMP standards are not prescriptive instructions on how to manufacture products. They are

315-430: A product from start to finish. In the late 19th century pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Birland established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure

360-460: A recognized profession. As Lee and Dale (1998) state, there are many organizations that are striving to assess the methods and ways in which their overall productivity, the quality of their products and services and the required operations to achieve them are done. The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and

405-606: A series of performance based requirements that must be met during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs. Regulatory agencies have recently begun to look at more fundamental quality metrics of manufacturers than just compliance with basic GMP regulations. US-FDA has found that manufacturers who have implemented quality metrics programs gain

450-616: A standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects. Application of statistical control came later as a result of World War production methods, which were advanced by the work done of W. Edwards Deming , a statistician , after whom the Deming Prize for quality is named. Joseph M. Juran focused more on managing for quality. The first edition of Juran's Quality Control Handbook

495-519: A way to assure product safety and efficacy and customer satisfaction since at least 1983 and were instituted as requirements in a final rule published on October 7, 1996. The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. The rule is promulgated at 21 CFR 820. According to current Good Manufacturing Practice (GMP), medical device manufacturers have

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540-533: Is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction ( ISO 9001:2015 ). It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By

585-466: Is a sector-specific quality system designed for the social services sector and addresses quality principles that are specific to service delivery to vulnerable groups , such as empowerment, rights, and person-centredness . The Alliance for Performance Excellence is a network of state and local organizations that use the Baldrige Criteria for Performance Excellence at the grassroots level to improve

630-519: Is an example of a comprehensive state-wide training network. Member institutions Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University , (BRITE) at North Carolina Central University , and North Carolina Community College System’s BioNetwork operate multidisciplinary centers dedicated to workforce development for the biomanufacturing industry. MiraCosta College and Solano College in California developed

675-465: Is disposed of after a single use. Products manufactured for medical or food use must be produced in facilities designed and operated according to Good Manufacturing Practice (GMP) regulations. Cleanrooms are often required to control the levels of particulates and microorganisms. Sterilization and aseptic processing equipment are required for production of injectable products. Skilled professionals are required for positions throughout

720-448: Is enforced in the United States by the U.S. Food and Drug Administration (FDA), under Title 21 CFR . The regulations use the phrase "current good manufacturing practices" (CGMP) to describe these guidelines. Courts may theoretically hold that a product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards. However, since June 2007,

765-507: Is impossible to mix up labels at a manufacturer because there is only one label to each product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling. Drug manufacturers are regulated under a different section of the Code of Federal Regulations : The International Organization for Standardization 's ISO 9001:2015 series describes standards for

810-536: Is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world. The European Union 's GMP (EU GMP) enforces similar requirements to WHO GMP, as does the FDA's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines], Vietnam and others having highly developed/sophisticated GMP requirements. In

855-663: The Central Drugs Standard Control Organization ; in Pakistan by the Drug Regulatory Authority of Pakistan ; in Nigeria by NAFDAC ; and by similar national organizations worldwide. Each of the inspectorates carries out routine GMP inspections to ensure that drug products are produced safely and correctly. Additionally, many countries perform pre-approval inspections (PAI) for GMP compliance prior to

900-456: The ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration. Other QMS, e.g. Natural Step , focus on sustainability issues and assume that other quality problems will be reduced as result of the systematic thinking, transparency, documentation and diagnostic discipline. The term "Quality Management System" and

945-588: The Malcolm Baldrige National Quality Award . The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results. The European Foundation for Quality Management 's EFQM Excellence Model supports an award scheme similar to

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990-566: The manufacturing industry to identify potential issues before they occur. Some benefits of quality management software include: Quality management software can be integrated with manufacturing execution systems (MES). A MES is a complete, dynamic software system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products. When combined with QMS, these systems: Quality management software focuses on 4 main elements: Most quality management software are cloud-based and offer software as

1035-437: The 1970's. These incidents resulted in hundreds of deaths, infections, and birth defects. Complete timelines show the emergence of Good Manufacturing Practices alongside these incidents, starting from 1938 in the US and 1970s internationally. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring

1080-487: The 20th century and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession. The quality profession grew from simple control to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine , accounting , and engineering , quality has achieved status as

1125-458: The 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes,

1170-583: The Baldrige Award for European companies. In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organizations that have displayed outstanding performance in the areas of Quality and workplace wellness , and have met the institute's criteria with documented overall achievements and results. The European Quality in Social Service (EQUASS )

1215-1053: The Republic of Korea (South Korea) by the Ministry of Food and Drug Safety (MFDS); in Australia by the Therapeutic Goods Administration (TGA); in Bangladesh by the Directorate General of Drug Administration (DGDA); in South Africa by the Medicines Control Council (MCC); in Brazil by the National Health Surveillance Agency (ANVISA); in India by state Food and Drugs Administrations (FDA), reporting to

1260-719: The U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials. Within the European Union GMP inspections are performed by National Regulatory Agencies. GMP inspections are performed in Canada by the Health Products and Food Branch Inspectorate; in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA); in

1305-635: The US FDA 21 CFR 820 regulations. The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines. ISO 13485 are harmonized with the European Union Regulation 2017/745 as well as the IVD and AIMD directives. The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS). Quality System requirements for medical devices have been internationally recognized as

1350-470: The United Kingdom, United States, Canada, various European countries, China, India and other countries. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation. All guidelines follow

1395-705: The United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide," which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors . Since the 1999 publication of Good Manufacturing Practice for Active Pharmaceutical Ingredients , by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and

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1440-473: The approval of a new drug for marketing. Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many European nations) are authorized to conduct unannounced inspections, though some are scheduled. FDA routine domestic inspections are usually unannounced, but must be conducted according to 704(a) of the Food, Drug and Cosmetic Act (21 USCS § 374), which requires that they are performed at

1485-511: The end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS). Good manufacturing practice, along with good agricultural practice , good laboratory practice and good clinical practice , are overseen by regulatory agencies in

1530-458: The first bachelor of science degree in biomanufacturing. The degree is largely lab-based and is built on a contextualized science and statistics backbone. The upper division classes recognize the unique environment of biological production where the process sciences and technology thrive in partnership with quality and regulatory compliance. Good manufacturing practice Current good manufacturing practices ( cGMP ) are those conforming to

1575-406: The fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements. The Baldrige Performance Excellence Program educates organizations in improving their performance and administers

1620-819: The guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , cosmetics , pharmaceutical products , dietary supplements , and medical devices . These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. Good Manufacturing Practice emerged in response to serious incidents of harm caused by contaminated, adulterated, or improperly manufactured products. Major incidents include: deaths from Elixir Sulfanilamide in 1937, thalidomide -induced birthdefects 1957-1961, poliomyelitis infections from improperly prepared vaccines in 1955, and Dalkon Shield -induced septicemia in

1665-687: The initialism "QMS" were invented in 1991 by Ken Croucher, a British management consultant working on designing and implementing a generic model of a QMS within the IT industry. The concept of a quality as we think of it now first emerged from the Industrial Revolution . Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet 'quality criteria'. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete

1710-743: The life cycle of a biomanufacturing product, which includes: Details for some of these positions are listed in “The Model Employee,” published by the North Carolina Biotechnology Center . In addition, the North Carolina Association for Biomedical Research (NCABR) maintains the website About Bioscience that offers free online videos on various careers. Several academic institutions have developed curricula and built facilities to provide education and training in biomanufacturing to students from community colleges, universities, and/or industry. NCBioImpact , established in 2004,

1755-580: The performance of local organizations and economies. browsers can find Alliance members in their state and get the latest news and events from the Baldrige community. A QMS process is an element of an organizational QMS. The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes. Butterworth-Heinemann and other publishers have offered several books which provide step-by-step guides to those seeking

1800-421: The quality certifications of their products. Examples of such processes include: comply with specific requirements e.g. statistical process control and measurement systems analysis , ISO 9001 requires that the performance of these processes be measured, analyzed and continually improved , and the results of this form an input into the management review process. Quality management software offers

1845-607: The quality system requirements. The FDA has identified in the QS regulation the 7 essential subsystems of a quality system. These subsystems include: all overseen by management and quality audits. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it

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1890-654: The responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation. As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet

1935-550: The role of quality culture in driving behaviors. In addition, non-governmental organizations such as the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA) have developed information and resources to help pharmaceutical companies better understand why quality culture is important and how to assess the current situation within a site or organization. GMP

1980-408: The techniques, processes, structure, and resources needed to simplify manufacturing and ERP activities while handling quality concerns efficiently and cost-effectively. Helps manufacturers to monitor, control, and document quality processes electronically to guarantee that goods are made within tolerance, meet all necessary requirements, and are defect-free. Quality management software is often used in

2025-411: Was published in 1951. He also developed the "Juran's trilogy", an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control, and quality improvement. These functions all play a vital role when evaluating quality. Quality, as a profession and the managerial process associated with the quality function, was introduced during the second half of

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