286 IVIVC and GMP Flashcards
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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
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
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
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
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.
What can GMP protect customers from buying?
Protects customers from purchasing a product which is ineffective or even dangerous
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
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
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
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
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
QC QA & GMP inter-relationship of quality management
QC is part of _____
QC is part of GMP
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
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
GMP is implemented in all aspects of production, which are? (3 things)
Raw material qualification
Personnel training & hygiene
Premises and Equipment
What are the five Ps?
Premises Primary materials People Procedures Processes defined and recorded
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?)
Better processes will lead to products with less _______
Variability
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
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
The folds of K_____ increase the small intestine SA 3 fold
Keckring
The presence of _____ increases SA of small intestines 30 fold
Villi
Micro villi increase SA 600 fold
In the duodenum, acid from the stomach is neutralised by secretions of ______
Bicarbonate
Large intestine SA v small compared to small intestine as it lacks _____
Lacks villi
What three types of drugs reduce emptying rate?
Anticholinergics
Narcotics
Ethanol
