286 IVIVC and GMP

Question 1

what is dissolution? biopharm approach

Answer 1

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

Question 2

what is bioavailability?

Answer 2

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

Question 3

what is bioequivalence?

Answer 3

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

Question 4

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

Answer 4

level A correlation

this is a good strong correlation

Question 5

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

Answer 5

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

Question 6

What can GMP protect customers from buying?

Answer 6

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

Question 7

What is cGMP?

Answer 7

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

Question 8

How does GMP relate to pharmaceutical products then?

Answer 8

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

Question 9

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

Answer 9

GMP Ensures their safety, efficacy and Quality

Question 10

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

Answer 10

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

Question 11

QC QA & GMP inter-relationship of Quality management

GMP is part of _______

Answer 11

GMP is part of quality assurance

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

Question 12

QC QA & GMP inter-relationship of quality management

QC is part of _____

Answer 12

QC is part of GMP

Question 13

What is QC all about ?

Answer 13

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 

Question 14

What’s QA all about?

Answer 14

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

Question 15

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

Answer 15

Raw material qualification
Personnel training & hygiene
Premises and Equipment

Question 16

What are the five Ps?

Answer 16

Premises
Primary materials
People
Procedures
Processes defined and recorded

Question 17

What is Quality by design?

Answer 17

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?)

Question 18

Better processes will lead to products with less _______

Answer 18

Variability

Question 19

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

Answer 19

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

Question 20

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

Answer 20

GSK and Mclaren (race cars)

Transferable skills: the Mclaren group are to share their ultra technological high performance skills

Question 21

The folds of K_____ increase the small intestine SA 3 fold

Answer 21

Keckring

Question 22

The presence of _____ increases SA of small intestines 30 fold

Answer 22

Villi

Micro villi increase SA 600 fold

Question 23

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

Answer 23

Bicarbonate

Question 24

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

Answer 24

Lacks villi

Question 25

What three types of drugs reduce emptying rate?

Answer 25

Anticholinergics
Narcotics
Ethanol