What are cgmps - Study guides, Class notes & Summaries

What does HAACP stand for? - Answer-Hazard Analysis Critical Control Points What is HACCP? - Answer-Systematic approach to the identification, evaluation, and control of food safety hazards HACCP's method is based on _______ rather than inspection - Answer-Prevention HACCP is focused solely on _____ not product quality - Answer-Hazards Where was HACCP originated? - Answer-Food for Manned Space Flights Pillsbury Company & NASA What is the problem with end-product sampling? - Answer-- No r...

What does HAACP stand for? Hazard Analysis Critical Control Points What is HACCP? Systematic approach to the identification, evaluation, and control of food safety hazards HACCP's method is based on _______ rather than inspection Prevention HACCP is focused solely on _____ not product quality Hazards Where was HACCP originated? Food for Manned Space Flights Pillsbury Company & NASA What is the problem with end-product sampling? - No real assurance of safety - Impractical, destructi...

RAC Chapter 18N (15)- OTC Drug Products Questions and Answers In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: ANSWER • habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? ANSWER • benefits clearly outweigh p...

RAC Chapter 18N (15)- OTC Drug Products Questions And Answers In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: - ANS-• habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? - ANS-• benefits clearly outweigh pos...

Biotechnician Assistant Credentialing Practice Exam Latest Update Graded A After performing the PCR reaction with the primers she designed to amplify lanA, the same technician found that her PCR reaction contained two distinct bands, one at the expected size of 1200 kilobase pairs, and another unexpected band at 2000 kilobase pairs. What is the most likely reason there is an unexpected band in her PCR reaction? She used an annealing temperature that was too low In a biotechnology lab, tap wate...

4 stages of drug system 1. Research and devlopment 2. Regulatory review 3. Manufacturing, marketing and distribution 4. Medication use system What are CGMPs and why are they important Current good manufacturing practices, detect is a productive is safe and if it will work. What does a drug company spend the most money on Marketing 4 ways drug companies s market drugs to health care professions 1. Give out freebies 2. Sponsor 3. Ads 4. Detailing (drug reps talk and ...

In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: - Answer-• habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? - Answer-• benefits clearly outweigh possible risks • potential for misuse and abuse is low •...

TX MPJE Summary Notes Latest Updates 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 ...

Texas pharmacist can administer all vaccines - ANSWER True requires written protocol with MD What age can pharmacist administer influenza - ANSWER 7 Can C2 prescriptions be refilled? - ANSWER no therefore no emergency refills What is the min age for vaccines other than the flu? except? - ANSWER 14 unless the child is referred by a physician can only be given at pharmacy or location provided in protocol (LTCF) How many hours for nuclear training - ANSWER 700 hours State board ...

MPJE Section 1 Questions and Answers 2023 Food, Drug, and Cosmetic Act of 1938 Followed deaths caused by sulfanilamide elixir 1937 Requires new drugs to be proven safe prior to marketing Established FDA Primary federal Law dealing with food, drug, cosmetic and medical device safety today (has lots of amendments) Durham-Humphre Amendments of 1951 2 classes of drugs: RX OTC Authorized verbal prescriptions and prescription refills Study tip: RX vs OTC Expect...