A new approach to the development of a risk management ontology is presented. This method meets the requirements of a pharmaceutical Quality by Design approach, good manufacturing practice and good automated manufacturing practice. The need for a risk management ontology for a pharmaceutical environment is demonstrated, and the term ‘‘ontology’’ is generally defined and described with regard to...

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials involving the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, integrity and confidentiality and well being of trial subjects are ...

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in it...

Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.

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background and objectives: pre-requisite programs (prps) are “primary conditions and requirements essential for haccp operations, which are crucial in food safety programs”. the present study was conducted to evaluate the impact of implementation of prps on the microbial parameters of pasteurized milk (according to the national standard of iran). effectiveness of haccp operation requirements an...

The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulatio...