Exam (elaborations)
MY FINAL EXAM CARDS BTEC 3320 QUESTIONS WITH 100% CORRECT SOLUTIONS!!
- Course
- Institution
MY FINAL EXAM CARDS BTEC 3320 QUESTIONS WITH 100% CORRECT SOLUTIONS!!
[Show more]
Content preview
MY FINAL EXAMCARDS BTEC 3320
QUESTIONS WITH
100% CORRECT
SOLUTIONS!!
BTEC 3320
Evatee 9/29/24 BTEC 3320
,MY FINAL EXAM CARDS BTEC 3320
QUESTIONS WITH 100% CORRECT
SOLUTIONS!!
What is not true of cGMPs?
cGMPs include guidelines in ICHQ7A
cGMPs includes Acts passed by the FDA
cGMPS require compliance with regulations as in CFR21 Part 211
cGMPs apply to drugs and devices
cGMPs apply to both marketed and investigational drugs Answer - cGMPs
includes Acts passed by the FDA
What applies to ISO9000 but not to GMP regulations?
Compliance to ISO9000 standards is required by law
ISO9000 regulations are specific to the pharma or medical industry
,Quality manual is not required
Compliance is monitored by a paid auditor who provides suggestions for
improvement
Originated in the United States Answer - Compliance is monitored by a paid
auditor who provides suggestions for improvement
The use of the term "current Good Manufacturing Practice" first became
prevalent in the:
"Federal Food, Drug and Cosmetic Act of 1938"
Biologics Control Act of 1902
Sherley Amendment of 1912
Kefauver-Harris Amendments of 1962
Pure Foods and Drug Act of 1906 Answer - Kefauver-Harris Amendments of
1962
"According to the International Organization for Standardization (ISO) website a
standard is a _______________ that provides requirements, specifications,
guidelines or characteristics that can be used consistently to ensure that
materials, products, processes and services are fit for their purpose." Answer -
Document
, What is not a major benefit in internal operations that comes with a company
being ISO certified?
enhanced inter-company communications
Improved documentation
greater operational efficiency & productivity
increased scrap and rework expenses
greater quality awareness by employees Answer - increased scrap and rework
expenses
(ISO certification should REDUCE expenses)
"What quality attribute was added as a requirement for drugs prior to
marketing in the Kefauver-Harris Amendments of 1962, but not in the Food
Drug and Cosmetic Act of 1938?"
Fitness
Safety
Purity
Strength
Efficacy Answer - Efficacy
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller EvaTee. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $27.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
82956 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now