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Validation (drug Manufacture)
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 * Cleaning validati ... [...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)
In software project management, software testing, and software engineering, verification and validation is the process of checking that a software engineer system meets specifications and requirements so that it fulfills its intended purpose. It may also be referred to as software quality control. It is normally the responsibility of software testers as part of the software development lifecycle. In simple terms, software verification is: "Assuming we should build X, does our software achieve its goals without any bugs or gaps?" On the other hand, software validation is: "Was X what we should have built? Does X meet the high-level requirements?" Definitions Verification and validation are not the same thing, although they are often confused. Boehm succinctly expressed the difference as * Verification: Are we building the product right? * Validation: Are we building the right product? "Building the product right" checks that the ''specifications'' are correctly implemented by ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Manufacturing
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling Milling may refer to: * Milling (minting), forming narrow ridges around the edge of a coin * Milling (grinding), breaking solid materials into smaller pieces by grinding, crushing, or cutting in a mill * Milling (machining), a process of using ro ..., Granulation (process), granulation, Coated tablet, coating, tablet pressing, and others. Scale-up considerations Cooling While a laboratory may use dry ice as a cooling agent for reaction selectivity, this process gets complicated on an industrial scale. The cost to cool a typical reactor to this temperature is large, and the viscosity of the reagents typically also increases as the temperature lowers, leading to difficult mixing. This results in added costs to stir harder and replace part ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease symptoms. Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment. Description The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (clinical trials) or observational studies on human participants. Clinical research can cover any medical method or product from it ... [...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 a scientific abstract and citation database, launched by the academic publisher Elsevier as a competitor to older Web of Science in 2004. The ensuing competition between the two databases has been characterized as "intense" and is c .... External links * Public health journals Academic journals established in 1997 English-language journals Publications disestablished in 2011 Defunct journals of the United States Quarterly journals Wiley (publisher) academ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ASTM
ASTM International, formerly known as American Society for Testing and Materials, is a standards organization that develops and publishes voluntary consensus technical international standards for a wide range of materials, products, systems and services. Some 12,575 apply globally. The headquarters is in West Conshohocken, Pennsylvania, about northwest of Philadelphia. It was founded in 1902 as the American Section of the International Association for Testing Materials. In addition to its traditional standards work, ASTM operates several global initiatives advancing additive manufacturing, advanced manufacturing, and emerging technologies, including the Additive Manufacturing Center of Excellence (AM CoE), the acquisition oWohlers Associatesfor market intelligence and advisory services, and the NIST-funded Standardization Center of Excellence (SCOE). History In 1898, a group of scientists and engineers, led by chemist, industry leader, and proponent of standardization Ch ... [...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 over 200-year old 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 ... [...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 othe ... [...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 specification (technical standard), 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 reality, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, A Guide to the Project Management Body of Knowledge, 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 assu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Integrity
Data integrity is the maintenance of, and the assurance of, data accuracy and consistency over its entire Information Lifecycle Management, life-cycle. It is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data. The term is broad in scope and may have widely different meanings depending on the specific context even under the same general umbrella of computing. It is at times used as a proxy term for data quality, while data validation is a prerequisite for data integrity. Definition Data integrity is the opposite of data corruption. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended (such as a database correctly rejecting mutually exclusive possibilities). Moreover, upon later Data retrieval, retrieval, ensure the data is the same as when it was originally recorded. In short, data integrity aims to prevent unintentional changes to information. Data integrity is no ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
