Misplaced Pages

#124875

51-499: 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 the 1970's. These incidents resulted in hundreds of deaths, infections, and birth defects. Complete timelines show

102-457: 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. Elixir Sulfanilamide Elixir sulfanilamide

153-470: A bleak outlook on the future as I have tonight." Congress responded to public outrage by passing the 1938 Food, Drug, and Cosmetic Act, which required companies to perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products. The Massengill Company paid a minimum fine under provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling

204-514: 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

255-535: 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

306-439: 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 is used by pharmaceutical regulators and

357-454: A doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such

408-533: A document is submitted directly for approval as a draft International Standard (DIS) to the ISO member bodies or as a final draft International Standard (FDIS), if the document was developed by an international standardizing body recognized by the ISO Council. The first step, a proposal of work (New Proposal), is approved at the relevant subcommittee or technical committee (e.g., SC 29 and JTC 1 respectively in

459-442: A long process that commonly starts with the proposal of new work within a committee. Some abbreviations used for marking a standard with its status are: Abbreviations used for amendments are: Other abbreviations are: International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a process with six steps: The TC/SC may set up working groups  (WG) of experts for

510-412: 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 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

561-533: A proposal to form a new global standards body. In October 1946, ISA and UNSCC delegates from 25 countries met in London and agreed to join forces to create the International Organization for Standardization. The organization officially began operations on 23 February 1947. ISO Standards were originally known as ISO Recommendations ( ISO/R ), e.g., " ISO 1 " was issued in 1951 as "ISO/R 1". ISO

SECTION 10

#1733084881125

612-436: A relatively small number of standards, ISO standards are not available free of charge, but rather for a purchase fee, which has been seen by some as unaffordable for small open-source projects. The process of developing standards within ISO was criticized around 2007 as being too difficult for timely completion of large and complex standards, and some members were failing to respond to ballots, causing problems in completing

663-637: Is "to develop worldwide Information and Communication Technology (ICT) standards for business and consumer applications." There was previously also a JTC 2 that was created in 2009 for a joint project to establish common terminology for "standardization in the field of energy efficiency and renewable energy sources". It was later disbanded. As of 2022 , there are 167 national members representing ISO in their country, with each country having only one member. ISO has three membership categories, Participating members are called "P" members, as opposed to observing members, who are called "O" members. ISO

714-462: Is a voluntary organization whose members are recognized authorities on standards, each one representing one country. Members meet annually at a General Assembly to discuss the strategic objectives of ISO. The organization is coordinated by a central secretariat based in Geneva . A council with a rotating membership of 20 member bodies provides guidance and governance, including setting the annual budget of

765-464: Is abused, ISO should halt the process... ISO is an engineering old boys club and these things are boring so you have to have a lot of passion ... then suddenly you have an investment of a lot of money and lobbying and you get artificial results. The process is not set up to deal with intensive corporate lobbying and so you end up with something being a standard that is not clear. International Workshop Agreements (IWAs) are documents that establish

816-508: Is an abbreviation for "International Standardization Organization" or a similar title in another language, the letters do not officially represent an acronym or initialism . The organization provides this explanation of the name: Because 'International Organization for Standardization' would have different acronyms in different languages (IOS in English, OIN in French), our founders decided to give it

867-971: Is an independent, non-governmental , international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes. ISO was founded on 23 February 1947, and (as of July 2024 ) it has published over 25,000 international standards covering almost all aspects of technology and manufacturing. It has over 800 technical committees (TCs) and subcommittees (SCs) to take care of standards development. The organization develops and publishes international standards in technical and nontechnical fields, including everything from manufactured products and technology to food safety, transport, IT, agriculture, and healthcare. More specialized topics like electrical and electronic engineering are instead handled by

918-512: Is approved as an International Standard (IS) if a two-thirds majority of the P-members of the TC/SC is in favour and not more than one-quarter of the total number of votes cast are negative. After approval, the document is published by the ISO central secretariat , with only minor editorial changes introduced in the publication process before the publication as an International Standard. Except for

969-499: 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,

1020-522: Is funded by a combination of: International standards are the main products of ISO. It also publishes technical reports, technical specifications, publicly available specifications, technical corrigenda (corrections), and guides. International standards Technical reports For example: Technical and publicly available specifications For example: Technical corrigenda ISO guides For example: ISO documents have strict copyright restrictions and ISO charges for most copies. As of 2020 ,

1071-425: Is produced, for example, for audio and video coding standards is called a verification model (VM) (previously also called a "simulation and test model"). When a sufficient confidence in the stability of the standard under development is reached, a working draft (WD) is produced. This is in the form of a standard, but is kept internal to working group for revision. When a working draft is sufficiently mature and

SECTION 20

#1733084881125

1122-590: Is restricted. The organization that is known today as ISO began in 1926 as the International Federation of the National Standardizing Associations ( ISA ), which primarily focused on mechanical engineering . The ISA was suspended in 1942 during World War II but, after the war, the ISA was approached by the recently-formed United Nations Standards Coordinating Committee (UNSCC) with

1173-542: The American Medical Association received a report of several deaths caused by the medication. The Food and Drug Administration was notified, and an extensive search was conducted to recover the distributed medicine. Frances Oldham Kelsey assisted on a research project that verified that the DEG solvent was responsible for the fatal adverse effects . At least 100 deaths were blamed on the medication. The owner of

1224-660: 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

1275-630: The International Electrotechnical Commission . It is headquartered in Geneva , Switzerland. The three official languages of ISO are English , French , and Russian . The International Organization for Standardization in French is Organisation internationale de normalisation and in Russian, Международная организация по стандартизации ( Mezhdunarodnaya organizatsiya po standartizatsii ). Although one might think ISO

1326-560: The Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control in the United States of America for drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisonings. In 1937, S. E. Massengill Company , a pharmaceutical manufacturer, created an oral preparation of sulfanilamide using diethylene glycol (DEG) as

1377-447: 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

1428-419: The solvent or excipient , and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans and other mammals, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this. (Although the first case of a fatality from the related ethylene glycol occurred in 1930 and studies had been published in medical journals stating DEG could cause kidney damage or failure, its toxicity

1479-1048: 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

1530-716: 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

1581-704: 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

Good manufacturing practice - Misplaced Pages Continue

1632-424: 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 a series of performance based requirements that must be met during manufacturing. When

1683-464: 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

1734-479: The case of MPEG, the Moving Picture Experts Group ). A working group (WG) of experts is typically set up by the subcommittee for the preparation of a working draft (e.g., MPEG is a collection of seven working groups as of 2023). When the scope of a new work is sufficiently clarified, some of the working groups may make an open request for proposals—known as a "call for proposals". The first document that

1785-418: The central secretariat. The technical management board is responsible for more than 250 technical committees , who develop the ISO standards. ISO has a joint technical committee (JTC) with the International Electrotechnical Commission (IEC) to develop standards relating to information technology (IT). Known as JTC 1 and entitled "Information technology", it was created in 1987 and its mission

1836-458: The company, when pressed to admit some measure of culpability, infamously answered, "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." Watkins, the chemist, committed suicide while awaiting trial. A woman wrote to U.S. President Roosevelt and described the death of her daughter: "The first time I ever had occasion to call in

1887-421: The confidence people have in the standards setting process", and alleged that ISO did not carry out its responsibility. He also said that Microsoft had intensely lobbied many countries that traditionally had not participated in ISO and stacked technical committees with Microsoft employees, solution providers, and resellers sympathetic to Office Open XML: When you have a process built on trust and when that trust

1938-413: The document, the draft is then approved for submission as a Final Draft International Standard (FDIS) if a two-thirds majority of the P-members of the TC/SC are in favour and if not more than one-quarter of the total number of votes cast are negative. ISO will then hold a ballot among the national bodies where no technical changes are allowed (a yes/no final approval ballot), within a period of two months. It

1989-493: 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 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

2040-708: The necessary steps within the prescribed time limits. In some cases, alternative processes have been used to develop standards outside of ISO and then submit them for its approval. A more rapid "fast-track" approval procedure was used in ISO/IEC JTC 1 for the standardization of Office Open XML (OOXML, ISO/IEC 29500, approved in April 2008), and another rapid alternative "publicly available specification" (PAS) process had been used by OASIS to obtain approval of OpenDocument as an ISO/IEC standard (ISO/IEC 26300, approved in May 2006). As

2091-489: The next stage, called the "enquiry stage". After a consensus to proceed is established, the subcommittee will produce a draft international standard (DIS), and the text is submitted to national bodies for voting and comment within a period of five months. A document in the DIS stage is available to the public for purchase and may be referred to with its ISO DIS reference number. Following consideration of any comments and revision of

Good manufacturing practice - Misplaced Pages Continue

2142-489: The preparation an " elixir " if it contained no ethanol . International Organization for Standardization Early research and development: Merging the networks and creating the Internet: Commercialization, privatization, broader access leads to the modern Internet: Examples of Internet services: The International Organization for Standardization ( ISO / ˈ aɪ s oʊ / )

2193-411: The preparation of a working drafts. Subcommittees may have several working groups, which may have several Sub Groups (SG). It is possible to omit certain stages, if there is a document with a certain degree of maturity at the start of a standardization project, for example, a standard developed by another organization. ISO/IEC directives also allow the so-called "Fast-track procedure". In this procedure,

2244-569: 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 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

2295-548: 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

2346-468: The short form ISO . ISO is derived from the Greek word isos ( ίσος , meaning "equal"). Whatever the country, whatever the language, the short form of our name is always ISO . During the founding meetings of the new organization, however, the Greek word explanation was not invoked, so this meaning may be a false etymology . Both the name ISO and the ISO logo are registered trademarks and their use

2397-501: The subcommittee is satisfied that it has developed an appropriate technical document for the problem being addressed, it becomes a committee draft (CD) and is sent to the P-member national bodies of the SC for the collection of formal comments. Revisions may be made in response to the comments, and successive committee drafts may be produced and circulated until consensus is reached to proceed to

2448-414: The typical cost of a copy of an ISO standard is about US$ 120 or more (and electronic copies typically have a single-user license, so they cannot be shared among groups of people). Some standards by ISO and its official U.S. representative (and, via the U.S. National Committee, the International Electrotechnical Commission ) are made freely available. A standard published by ISO/IEC is the last stage of

2499-411: Was an improperly prepared sulfonamide antibiotic that caused mass poisoning in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act , which significantly increased the Food and Drug Administration 's powers to regulate drugs. Aside from

2550-453: Was not widely known prior to the incident.) Watkins simply mixed raspberry flavoring into the powdered drug and then dissolved the mixture in DEG. Animal testing was not required by law, and Massengill performed none; there were no regulations at the time requiring premarket safety testing of drugs. The company started selling and distributing the medication in September 1937. By October 11,

2601-513: Was suggested at the time by Martin Bryan, the outgoing convenor (chairman) of working group 1 (WG1) of ISO/IEC JTC 1/SC 34 , the rules of ISO were eventually tightened so that participating members that fail to respond to votes are demoted to observer status. The computer security entrepreneur and Ubuntu founder, Mark Shuttleworth , was quoted in a ZDNet blog article in 2008 about the process of standardization of OOXML as saying: "I think it de-values

SECTION 50

#1733084881125
#124875