Related Research Articles
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 management system (QMS).
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or causes prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- May have caused a congenital anomaly/birth defect
- Requires intervention to prevent permanent impairment or damage
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. It was jointly established by the World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as a successor to the International Medical Congress that organized 17 conferences from 1867 until the 1913 outbreak of World War One.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
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:
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities and the members of the medical device industry” whose goal was the standardization of medical device regulation across the world. The representatives from its five founding members were divided into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical devices."
Alternatives to animal testing are the development and implementation of test methods that avoid the use of live animals.
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.
Verification and validation 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. "Integration verification and validation" can be abbreviated as "IV&V".
Safety pharmacology is a branch of pharmacology specialising in detecting and investigating potential undesirable pharmacodynamic effects of new chemical entities (NCEs) on physiological functions in relation to exposure in the therapeutic range and above.
The Certification Authority Browser Forum, also known as the CA/Browser Forum, is a voluntary consortium of certification authorities, vendors of Internet browser and secure email software, operating systems, and other PKI-enabled applications that promulgates industry guidelines governing the issuance and management of X.509 v.3 digital certificates that chain to a trust anchor embedded in such applications. Its guidelines cover certificates used for the SSL/TLS protocol and code signing, as well as system and network security of certificate authorities.
Bioanalysis is a sub-discipline of analytical chemistry covering the quantitative measurement of xenobiotics and biotics in biological systems.
Sarfaraz Khan Niazi he migrated to Karachi, Pakistan in 1962, and to the United States in 1970. He is an expert in biopharmaceutical manufacturing and has worked in academia, industry, and as an entrepreneur. He has written books in pharmaceutical sciences, biotechnology, consumer healthcare, and poetry. He has translated ghazals of the Urdu poet Ghalib.
An electronic trial master file (eTMF) is a trial master file in electronic format. It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content. Regulatory agencies have outlined the required components of eTMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation.
A hybridization assay comprises any form of quantifiable hybridization i.e. the quantitative annealing of two complementary strands of nucleic acids, known as nucleic acid hybridization.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
References
- ↑ Smith, Graeme (2010-05-07). "Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance". Bioanalysis. 2 (5): 929–35. doi: 10.4155/bio.10.42 . PMID 21083222.
- ↑ Abbott, Richard W; Margarete Brudny-Kloeppel (2009-06-11). "European Bioanalysis Forum, 1st Open Symposium: "Burning Issues in Bioanalysis"" (PDF). Bioanalysis. 1 (2): 273–6. doi:10.4155/bio.09.24. PMID 21083164 . Retrieved 2010-05-13.
- ↑ Lausecker, Berthold; Peter van Amsterdam; Margarete Brudny-Kloeppel; Silke Luedtke; Philip Timmerman (2009-08-27). "European Bioanalysis Forum and the way forward towards harmonized regulations" (PDF). Bioanalysis. 1 (5): 873–5. doi:10.4155/bio.09.96. PMID 21083056 . Retrieved 2010-05-13.
- ↑ Timmerman, Philip; Silke Luedtke; Peter van Amsterdam; Margarete Brudny-Kloeppel; Berthold Lausecker; Stephanie Fischmann; Susanne Globig; Carl-Johan Sennbro; Josep M Jansat; Hans Mulder; Elizabeth Thomas; Magnus Knutsson; Dirk Kasel; Stephen A White; Morten Anders Kall; Nathalie Mokrzycki-Issartel; Achim Freisleben; Fernando Romero; Michael Pilgård Andersen; Norbert Knebel; Marcel de Zwart; Sirpa Laakso; Richard S Hucker; Dietmar Schmidt; Ben Gordon; Richard Abbott; Pierre Boulanger (2009-09-23). "Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum". Bioanalysis. 1 (6): 1049–56. doi:10.4155/bio.09.108. PMID 21083073.