LABS507 Week 1- GLP Exam 2023 Update

LABS507 Week 1- GLP Exam 2023 Update What is GXP? - ANS-A collective term for the good practice quality guidelines and regulations used in many industries What is the intention of GXP guidelines? - ANS-To ensure products are safe and capable of meeting intended use in accordance with regulatory standards What are some internationally recognised standards? - ANS-GLP, GCP, GPvP, GMP and GDP Who is responsible for checking all licensed medicines in the UK before they are given to patients? - ANS-The Medicines and Healthcare products regulatory Agents (MHRA) What is the main objective of the MHRA? - ANS-To protect the health of the general public by ensuring the safety and efficacy of medicines, healthcare products in the UK before they are given to patients How does the MHRA ensure safety of medicines before they are given to the general public? - ANS-A group of inspectors that monitor specific units What is the focus of GLP? - ANS-To assess the credibility of lab data submitted in cosmetics, food additives, agrochemicals and pharmaceuticals What is GLP? - ANS-Good Laboratory Practices What do GLP inspectors target? - ANS-Companies that perform non-clinical studies, which submit their data to authorities to examine the safety of new drugs to the environment, animals and humans What is GCP? - ANS-Good Clinical Practice What is the focus of GCP? - ANS-A range of sites including research organisations, clinical (and non-clinical) trial labs and pharma sponsor establishments What do GCP inspectors target? - ANS-They monitor if clinical trials are conducted in compliance with the requirements of EU guidelines and regulations What is GMP? - ANS-Good Manufacturing Practices What is the focus of GMP? - ANS-For manufacturing sites inside and outside of the UK for UK supply, to ensure products are made to the correct standards in safety, quality and efficacy What do GMP inspectors target? - ANS-They certify that medicines in the UK are consistently delivered to a high standard. They assess and authorise NHS manufacturing units, biological products, investiagtional medicinal products and blood product establishments What is GDP? - ANS-Good Distribution Practices What is the focus of GDP? - ANS-Designated sites used by wholesale traders for storing and distributing medicinal products What do GDP inspectors target? - ANS-They are in agreement with the requirements set by the Medicines for Human Use Regulations 2005 and the EC Guide for Good Distribution Practice for Medicinal Products for Human Use What is GPvP? - ANS-Good Pharmacovigilance Practice What is the focus of GPvP? - ANS-To ensure compliance post marketing for safety in clinical practice What do GPvP inspectors target? - ANS-They assess whether marketing authorisation holders are complaint with European legislations What distinct stages can the drug discovery process be separated into? - ANS--Basic research -Disease discovery -Drug discovery (not regulated) -Preclinical development (GLP) -Clinical trials I, II, III (GCP) -Manufacturing including APIs and QC labs (GMP) What is stage 1 of the drug discovery process? - ANS-It begins with elementary discovery methods and in turn the results may be used to define efficacy for prospect drugs. This generally involves screenings of thousands of NMEs to target a particular diseases. There are guidelines but no regulatory standards What are NMEs? - ANS-New Molecular Entities What is stage 2 of the drug discovery process? - ANS-Successful NMEs are examined by screening-type assays for potential toxic affects. This reduces the number of potential drugs taken to the next stage. Toxicology and safety pharmacology research must be compliant with GLP. The studies are non-clinical and are not performed on humans What is stage 3 of the drug discovery process? - ANS-The clinical stage, where GCP is fundamental for quality, ethical conduct and regulatory compliance. GCP is established in all clinical trials... Continues...