What are cgmps - Study guides, Class notes & Summaries

Learn2Serve Food Manager Certification – Exam Notes (2023/2024) High Risk foods include: - Protein rich, moist and at room temperature; "Ready-to-Eat" foods Food spoilage is caused by - Rough handling, exaggerated high or ow keeping temps, bacteria, enzymes, mold and pests Prerequisite programs to HACCP are based on what? - Good Manufacturing Practices (cGMPs) Deciding how often the entire HACCP system will be checked for flaws and efficiency is a part of what stage? - #6) ...

TX MPJE LATEST UPDATE GRADED A+ Food Drug and Cosmetic Act of 1938 Followed deaths by sulfanalimide elixier; required new drugs to be SAFE; established FDA as primary federal law dealing with food, drug, costmetic, and medical device safety Durham-Humphrey Act of 1951 Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for drugs and est...

PHR 2500 Final Exam With 100% Correct Answers 2024

BTECH Exam 12,13 Questions & Answers 2024/2025 Q 1 What is the first Act that required the inclusion of name and place of manufacture of drug in drug labels? - ANSWERSFair Packaging and Labeling Act What is a well built quality system not designed to prevent or reduce the number of? - ANSWERSEfficacious products entering the marketplace FDA's ____________ are guidelines that intend to integrate quality systems and risk management approaches into its existing programs with the goal o...

PHR 2500 Exam 2 With 100% Correct Answers 2024

PHR 2500 Final Exam (All Modules) With 100% Correct Answers 2024

A drug...shall be deemed adulterated...if...the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding, do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and _____________ and meets the quality and ______________ characteristics, which it purports or is represented to possess." solution:palata...

PHR 2500 Final Exam With 100% Correct Answers 2024

MPJE – Michigan Questions And Answers 100% Verified. Misbranding - correct answer. Drugs which are sold, dispensed or distributed in violation of labeling requirements of FDCA Adulterated or Misbranded?: False/misleading labeling - correct answer. Misbranded Adulterated or Misbranded?: Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity of drug - correct answer. Misbranded Adulterated or Misbranded?: Any wor...

BACE EXAM VERSION B QUESTIONS AND ANSWERS What event occurred in the 1950's that contributed to the growth of biotechnology? Structure of DNA described, as well as its method of replication The advent of recombinant DNA technology began with which of the following events? Isolation of restriction enzymes Which of the following statements is FALSE regarding vaccines? They signal the immune system to make antigens against the microorganism for which the vaccine was developed. ...