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Product development in biotechnology
Published in Firdos Alam Khan, Biotechnology Fundamentals, 2018
GMP regulations promulgated by the U.S. FDA under the authority of the Federal Food, Drug, and Cosmetic Act has the force of law and require that manufacturers, processors, and packagers of drugs, medical devices, food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn protects the consumer from purchasing a product that is not effective or may even be dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences, including recall, seizure, fines, and jail time. GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how best to implement the necessary controls. This provides much flexibility but also requires that the manufacturer interpret the requirements in a manner that makes sense for each individual business.
Product Development in Biotechnology
Published in Firdos Alam Khan, Biotechnology Fundamentals, 2020
GMP regulations promulgated by the US FDA under the authority of the Federal Food, Drug, and Cosmetic Act has the force of law and require that manufacturers, processors, and packagers of drugs, medical devices, food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn protects the consumer from purchasing a product that is not effective or may even be dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences, including recall, seizure, fines, and jail time. GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how best to implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner that makes sense for each individual business. GMP is also sometimes referred to as Current Good Manufacturing Practice (cGMP). The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems that are up-to-date to comply with the regulation. In the United States, the phrase “current GMP” appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21 USC 351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated, if the process was not performed according to industry standards.
Translation of Radiopharmaceuticals
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Pedro Fragoso Costa, Latifa Rbah-Vidal, An Aerts, Fijs W.B. van Leeuwen, Margret Schottelius
Given the unique characteristics of radiopharmaceuticals, there are additional requirements to be considered when bringing candidates into the clinic. In general, GMP will refer to quality management, equipment, personnel, documentation, production quality control, self-inspection, and outsourced activities [37, 38].
A comprehensive validation framework addressing utility parameter validation for application in small and medium enterprises (SMEs):A case study in pharmaceutical industry
Published in Cogent Engineering, 2023
Vothia Surian Subramaniam, Joshua Prakash, Shahrul Kamaruddin, Sze Wei Khoo
Quality of products manufactured is the main target of any industry. Achieving this target is the main interest of manufacturing companies, especially pharmaceutical industries which produce health-related products (Nandhakumar et al., 2011). Muddukrishna et al., (2016) emphasized that good personal hygiene is highly required in pharmaceutical companies to avoid any type of contamination which affects the quality of medicinal products, and this will ensure the production of hygienic, safe and top-quality medical products. This is essential since these products are used to treat patients and have direct impact on consumers’ lives. As such, pharmaceutical manufacturing companies which are capable of producing such products of requisite attribute and quality consistently with fast delivery and at the lowest possible cost would always be customers’ choice. In order to achieve this goal, the Food and Drug Administration (FDA) has introduced Good Manufacturing Practice (GMP) to maintain and improve the quality level of pharmaceutical products. GMP covers all the aspects of manufacturing process which ensures products are consistently produced appropriate to the intended use and as required by the marketing authorization. Hence, pharmaceutical companies adopted GMP to ensure that their products are manufactured to specific requirements including strength, quality and purity (Brhlikova et al., 2007). One of the major GMP requirements is that all the manufacturing facilities, utilities and equipment in the pharmaceutical industries must be properly validated before released for production use.
Manufacturing system sustainability through lean and agile initiatives
Published in International Journal of Sustainable Engineering, 2019
Vinay Venugopal, P. G. Saleeshya
The wide extensive literature review, a field study conducted helped us to identify an industry to do the case study. Industry selected for the study is an Ayurveda Pharmaceutical industry – situated in South India. In this industry, a need was felt to improve the operational efficiency. For this, the strategies such as leanness and agility are identified suitable. Also, sustainability is crucial in the field of Ayurveda pharmaceutical industry. The products should be manufactured with accurate precision and quality so that it should not be harmful to human beings. We have developed a questionnaire to capture information from the industry. The industry produces 100 types of drugs which involve arishtas, asavas, ghritham, kashayam, choornam, lehyam, gulikas, oils and thylams. The industry follows Good Manufacturing Practices (GMP) which is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. It follows batch production to convert a set of raw materials into drugs through stage by stage over a series of workstations. The raw materials should be mixed and processed as per specifications so that the drug does not have any side effects to both human being and environment. For doing the pairwise comparison of enablers and inhibitors we have conducted a brainstorming section including managers from different hierarchical levels. A combined lean and agile manufacturing model is developed with the pharmaceutical industry under consideration. Lean manufacturing practices can be applied in the industry to reduce the non-value added activities and eliminate different causes of wastes. Agile manufacturing practices can be applied to respond to the dynamic requirements of the customers and to sustain in the market. Both practices contribute to the sustainability of the system Singh et al., (2016). The details of the model are explained in the next section.