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Validation (drug Manufacture)
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: *Equipment validation *Facilities validation *HVAC system validation * Cleani ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to 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. 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 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 manageme ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Verification And Validation (software)
Verify or verification may refer to: General * Verification and validation, in engineering or quality management systems, is the act of reviewing, inspecting or testing, in order to establish and document that a product, service or system meets regulatory or technical standards ** Verification (spaceflight), in the space systems engineering area, covers the processes of qualification and acceptance * Verification theory, philosophical theory relating the meaning of a statement to how it is verified * Third-party verification, use of an independent organization to verify the identity of a customer * Authentication, confirming the truth of an attribute claimed by an entity, such as an identity * Forecast verification, verifying prognostic output from a numerical model * Verifiability (science), a scientific principle * Verification (audit), an auditing process Computing * Punched card verification, a data entry step performed after keypunching on a separate, keyboard-equipped ma ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, Vaccine, vaccinate them, or alleviate symptoms. List of pharmaceutical companies, Pharmaceutical companies may deal in Generic drug, generic or brand medications and medical devices. They are subject to a legal drug trade, variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and legal drug trade, marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United State ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Assurance Journal
The ''Quality Assurance Journal'' was a quarterly peer-reviewed healthcare journal published by John Wiley & Sons. It covered quality assurance issues relating to the healthcare and environmental industries. It was established in 1997 and ceased publication at the end of 2011. The founding editor-in-chief was David Long and the last editors were Rita Hattemer-Apostel and Anthony B. Jones. Abstracting and indexing The journal is abstracted and indexed in ProQuest databases, EMBASE, EMBASE, and Scopus Scopus is Elsevier's abstract and citation database launched in 2004. Scopus covers nearly 36,377 titles (22,794 active titles and 13,583 inactive titles) from approximately 11,678 publishers, of which 34,346 are peer-reviewed journals in top-l .... External links * Public health journals Publications established in 1997 English-language journals Publications disestablished in 2011 Defunct journals of the United States Quarterly journals Wiley (publisher) academic j ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ASTM
ASTM International, formerly known as American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Some 12,575 ASTM voluntary consensus standards operate globally. The organization's headquarters is in West Conshohocken, Pennsylvania, about northwest of Philadelphia. It is founded in 1902 as the American Section of the International Association for Testing Materials (see also International Organization for Standardization). History A group of scientists and engineers, led by Charles Dudley, formed ASTM in 1898 to address the frequent rail breaks affecting the fast-growing railroad industry. The group developed a standard for the steel used to fabricate rails. Originally called the "American Society for Testing Materials" in 1902, it became the "American Society for Testing And Materials" in 1961. In 2001, ASTM off ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Pharmacopeia
The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself. The ''USP'' is published in a combined volume with the ''National Formulary'' (a formulary) as the USP-NF. If a drug ingredient or drug product has an applicable ''USP'' quality standard (in the form of a ''USP-NF'' monograph), it must conform in order to use the designation "USP" or "NF". Drugs subject to ''USP'' standards include both human drugs ( prescription, over-the-counter, or otherwise) and animal drugs. ''USP-NF'' standards also have a role in US federal law; a drug or drug ingredient with a name recognized in ''USP-NF'' is considered adulterated if it does not satisfy compendial standards for strength, quality or purity. USP also sets standards for di ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of Therapeutic Goods
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia. The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be sold. There is usually some degree of restriction on the availability of certain therapeutic goods, depending on their risk to consumers. History Modern drug regulation has historical roots in the response to the proliferation of universal antidotes which appeared in the wake of Mithridates' death. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Inspection Convention And Pharmaceutical Inspection Co-operation Scheme
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry. History The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the ''Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products''. The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with ot ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Verification And Validation
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V". In practice, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, the PMBOK guide, a standard adopted by the Institute of Electrical and Electronics Engineers (IEEE), defines them as follows in its 4th edition: * "Validation. The assurance that a product, service, or system meets the needs of the customer and other id ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Automated Manufacturing Practice
Good automated manufacturing practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. More specifically, the ISPE's guide ''The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture'' describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. A group of pharmaceutical professionals have banded toget ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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