Gmp Samenvattingen, Aantekeningen en Examens

cGMP Exam 1 What type of training should personnel receive in order to remain qualified for their positions? - In the particular operations that the employee performs On a continuous basis with sufficient frequency In current good manufacturing practice as they relate to the employee's function. From qualified individuals. How many qualified personnel should a company have to perform and supervise the manufacture, processing, packing, or holding of each drug company? - An adequate nu...

What does CFR and HPFB stand for? What do they do? - Answer-CFR = Code of federal regulations HPFB = Health products and food branch set regulations that contain the minimum requirements for cGMP What is the goal of cGMP regulations? - Answer-To have a consistent process that will lead to a safe product that is of the quality and purity that it is purported to have What are the areas that must be compliant according to part 211 of cGMP regulations? - Answer-1) General Provisions 2) Or...

PGMP EXAM STUDY GUIDE

Dit document is een beknopte overzichtelijke samenvatting van met name de hoorcolleges, aangevuld met de literatuur uit het boek. Ik heb het gebruikt tijdens het tentamen om snel mijn kennis op te frissen en geen aspecten te vergeten. Het is daarmee een functioneel document die de onderwerpen in hoofdlijnen in kaart brengt.

PGMP EXAM QUESTIONS AND ANSWERS

PMI PGMP EXAM STUDY GUIDE

PgMP EXAM STUDY GUIDE

LP and GMP Principles Review Test 2023 What does GLP stand for? - ANS-good laboratory practices What does GMP stand for? - ANS-good manufacturing practices When were biologics manufactured on a large scale? - ANS-1980 What does CDER stand for? - ANS-Center for Drug Evaluation and Research What does the CDER regulate? - ANS-small molecules and drugs What does CBER stand for? - ANS-Center for Biologics Evaluation and Research What does CBER regulate? - ANS-biologics Which agency regulates ...

PgMP® Exam Practice Test and Study Guide with Solutions 2023/2024

GMP, GLP & GDP Questions And Answers 2023 What is the role of OA in a GLP study? - ANS-Make sure documentation is done correctly. What is the role of QA in a GMP environment? - ANS-Make sure documentation is done correctly (batch records, SOPs) Work with CAPA What is the essence of GDP? - ANS-If it's not documented, it didn't happen. What is the purpose of GDP? - ANS-To prove the manufacturer did what it said it would do. To comply with FDA regulations. To discover the root cause ...