The medicinal products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant GMP standards. We refer to these as Good Quality Control Laboratory Practice, or GQCLP. Regulatory authorities inspect laboratories to confirm that they meet the standards. This course explains how to comply with GQCLP, and it provides advice on laboratory work in general.
The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory authorities typically require GLP rules to be followed for nonclinical studies intended to support an application for approval of clinical research or marketing of a product containing the test item. This course outlines the history of GLP and explains why it is important, identifies the penalties that may be incurred for noncompliance, and sets out requirements that need to be met. Learners are also referred to the two main sources of GLP rules: The Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice and US Regulation 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies.
Understanding specific words and terms used in the healthcare sector is an absolute must if you are looking to progress in this profession. Once you have a basic understanding of how medical words are constructed they become easy to understand and use are internationally used by nurses, doctors, allied healthcare professionals, dentists and many other medical specialities.
Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + QLS Endorsement | Assessment & Tutor Support Included
Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included