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22 sty 2018 · INTRODUCTION • Good Engineering Practice (GEP) is defined as combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods intended to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities taking into account not only regulatory ...
Genetic engineering is the alteration of an organism’s genotype using recombinant DNA technology to modify an organism’s DNA to achieve desirable traits. The addition of foreign DNA in the form of recombinant DNA vectors generated by molecular cloning is the most common method of genetic engineering.
In this article, we’ll first examine the definition of biotechnology, seeing how it can encompass many different uses of organisms (and molecules or systems derived from organisms) to produce useful products. Then, we’ll take a closer look at DNA technology, techniques for manipulating and sequencing DNA.
Good engineering practice (GEP) is engineering and technical activities that ensure that a company manufactures products of the required quality as expected (e.g., by the relevant regulatory authorities).
The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems.
This ISPE Good Practice Guide aims to provide a definition and explanation of the term Good Engineering Practice (GEP). It describes the fundamental elements of GEP as it should exist in the pharmaceutical industry, encompassing core concepts and engineering practices.
This ISPE Good Practice Guide aims to provide a definition and explanation of the term “Good Engineering Practice” (GEP). It describes the fundamental elements of GEP as they should exist in pharmaceutical and related industries.
