286 IVIVC and GMP Flashcards Preview

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Flashcards in 286 IVIVC and GMP Deck (25)
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1

what is dissolution? biopharm approach

the amount of active ingredient in a solid dosage form that is dissolved per unit time under standardised conditions of liquid-solid interface, temperature, and media composition

2

what is bioavailability?

the rate/ extent to which an active ingredient is absorbed from a drug product and becomes available at the site of action

3

what is bioequivalence?

when there is no difference in the rate and extent of which the active ingredient becomes available at the site of drug action, between pharmaceutical equivalents, when administered at the same dose under similar conditions in a well designed study

4

if multiple level C correlation is achievable, then level __ correlation is also likely to be present

level A correlation
this is a good strong correlation

5

GMP is part of _________ _________ which ensures that products are consistently manufactured and controlled to the ______ ______ appropriate to their intended use.

GMP is part of Quality Assurance which ensures that products are consistently manufactured and controlled to the Quality Standards appropriate to their intended use.

6

What can GMP protect customers from buying?

Protects customers from purchasing a product which is ineffective or even dangerous

7

What is cGMP?

Current good manufacturing practice
It requires companies to use technologies and systems that are up to date in order to comply with regulations
Allows companies to use modern technologies and new approaches to achieve higher quality through continual improvement

8

How does GMP relate to pharmaceutical products then?

Any product sold in the UK that claims to have medicinal properties must have a Marketing Authorisation

The Health agency consider product dossier (documentation) and inspect the manufacturing site before issuing a Marketing License

Before obtaining a Marketing License, the manufacturing site must be GMP compliant

9

GMP provides a high level of assurance that medicines are manufactured in a way that ensures their _____,______, and _______

GMP Ensures their safety, efficacy and Quality

10

What four aspects are interrelated aspects of quality management, and should be the responsibility of all personnel?

Quality assurance
GMP
Quality control
Quality risk management
The relationship between these is important to the production and control of pharmaceuticals

11

QC QA & GMP inter-relationship of Quality management
GMP is part of _______

GMP is part of quality assurance
It is aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use

12

QC QA & GMP inter-relationship of quality management
QC is part of _____

QC is part of GMP

13

What is QC all about ?

QC is concerned with sampling, specification, and testing, documentation, and release procedures

These are to ensure that the necessary and relevant tests are performed, and that the product is released for use only after ascertaining its quality

Usually happens in a laboratory 

14

What's QA all about?

All the organized arrangements that ensure the product will be of the Quality required
It's all the systematic actions that are done to make sure that a product will satisfy requirements for quality

15

GMP is implemented in all aspects of production, which are? (3 things)

Raw material qualification
Personnel training & hygiene
Premises and Equipment

16

What are the five Ps?

Premises
Primary materials
People
Procedures
Processes defined and recorded

17

What is Quality by design?

To determine how material properties and processing conditions determine the structure of formulations and influence product functionality
It's used to develop predictive understanding of the relationship between structure and functionality (how does the structure of a product affect how it functions?)

18

Better processes will lead to products with less _______

Variability

19

What's an example of better processes we can use to give us less variability?

PAT
This is Process Analytical Technologies
This will give us more of a consistent output
Variable input -> adapted process -> consistent output -> drug product
Compare this to our current GMP processes:
Variable input -> fixed process -> variable output -> drug product

20

What's an example of two companies coming together to creat an innovative strategic partnership?

GSK and Mclaren (race cars)
Transferable skills: the Mclaren group are to share their ultra technological high performance skills

21

The folds of K_____ increase the small intestine SA 3 fold

Keckring

22

The presence of _____ increases SA of small intestines 30 fold

Villi

Micro villi increase SA 600 fold

23

In the duodenum, acid from the stomach is neutralised by secretions of ______

Bicarbonate

24

Large intestine SA v small compared to small intestine as it lacks _____

Lacks villi

25

What three types of drugs reduce emptying rate?

Anticholinergics
Narcotics
Ethanol

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