All The Major Topic Covered In this blog with most of information from Reference Source for quality Materials which gives you elaborate Information about the Major Topics
Books for Pharmaceutics
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Introduction to Regulatory Affairs What is Regulatory Affairs? Regulatory Affairs is a profession within regulated industries namely-pharmaceuticals, medical devices, energy and banking . It has specific meaning within healthcare industries namely- pharmaceuticals, medical devices, biologics and functional foods. (In this blog I am going to deal about Regulatory Affairs related to pharmaceuticals meant for human use). Regulatory Affairs in the pharma industry may be defined as " The interface between the pharmaceutical company and the regulatory agencies across the world. " In the above presentation, I am conveying the fact that -among all the departments of a pharma company Regulatory Affairs Department acts as the interface between the pharmaceutical company and the regulatory agencies across the world. Regulatory agency in the present context may be defined as " The competent government agency which is responsible for ensuring that medici
Gap Analysis for Regulatory Compliance Gap analysis is an effective tool to determine the deficiencies in implementation of any procedure or regulatory guidance. If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis. Gap analysis should be done for all SOPs, validation procedures and other activities to find out the possibilities of improvement. The room for improvement is identified by gap analysis. Therefore, make the checklists of the document you want to analyze and then check the actual working against the checklist. Gap analysis should also be done for regulatory guidelines like data integrity, risk assessment, good manufacturing practices, good laboratory practices, good documentation practices, good distribution practices etc to eliminate the possible non-compliances. Gap analysis may be carried out for specifi
The role of a Certificate of Suitability is to certify the compliance of a material with the requirements laid down in the relevant monograph of the European Pharmacopoeia. Active pharmaceutical ingredients for which a Certificate of Suitability has been granted are suitable for use in medicinal products. CEP What is the Full form of abbreviation, CEP? Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs It is also informally referred to as Certificate of Suitability (COS) What is a CEP? It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.
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