Ideation
Formulation Development
CTM Delivery
Tech Transfer
Final Jeopardy
100
This system has been developed to provide a scientific approach to allow for the prediction of in vivo pharmacokinetics of drug products by classifying compounds based on their solubility related to dose and intestinal permeability in combination with the dissolution properties of the dosage form.
What is the BCS Classification system?
100
I am the most constraining factor in formulating a drug product.
What is the Active Pharmaceutical Ingredient?
100
All clinical manufacturing and testing activities must be conducted following this standard.
What is Good Manufacturing Practice (GMP)
100
The action of proving and documenting that any process, procedure, or method actually and consistently leads to expected results
What is validation?
100
It is important to assess this as part of the Ideation Process in order to mitigate potential significant delays later in development.
What is the API Supply Chain?
200
A patent search which identifies the technologies and/or formulation approaches that are covered by other company's IP defines this.
What is Freedom to Operate?
200
The technical term for all inactive ingredients used in a product.
What are excipients?
200
Analytical test results are compiled in this QA approved document.
What is a Certificate of Analysis or CoA?
200
Batches of product using the intended commercial process that are the culmination/final step of a successful TT and are used to set product shelf life
What are registration/exhibit batches?
200
I am the ICH term used to provide a description of the product quality and design aspects for a new product that guide the overall product development.
What is the Quality Target Product Profile?
300
Information source for analytical methods and specifications for approved products.
What are pharmacopeias?
300
This manufacturing process consists of blending all ingredients and making the single dosage form.
What is Direct Compression?
300
A GMP compliant system used by GSK to document the shipment of clinical supplies to sites around the world.
What is Xpress?
300
This process examines the current understanding of the product being transferred compared to the intended ‘reliable state’
What is gap/risk analysis
300
The graph that displays the release of drug over time in a glass vessel is known as what pharmaceutical term?
What is the dissolution profile?
400
By examining the chemical structures of two APIs, Organic Chemists can assess whether or not this is likely to occur.
What are API to API stability interactions.
400
This process irreversibly defines many critical product qualities and can make 1 million dosage units in about 2.5 hours.
What is Tablet Compression (compaction)?
400
The process by which clinical grade API may be brought into the US when GSK does not have an open IND/NDA.
What is the Import for Export process?
400
A formal system used to determine if action is needed to ensure a system(s) remains in its validated state
What is change control?
400
The common name for the UK guidance titled “Rules and Guidance for Pharmaceutical Manufacturers and Distributors” which covers GMPs.
What is "The Orange Guide"?
500
This information about the API can help you know if you may have processing or dissolution issues in your formulation development.
What are physical properties?
500
If you mess up the last production process all of the previous steps are for naught. But if you get me right the products will be happily packaged and on their way. They will also look heavenly!
What is Tablet Coating?
500
All raw materials and APIs for use in clinical manufacture must have this designation prior to use.
What is QA approved status? or What is QA approved supplier?
500
A step in the process at which control is essential to prevent a quality incident from occurring
What is Critical Process Parameter (CPP)
500
This is the systematic process used to pass documented knowledge and experience from development to a capable commercial manufacturing unit.
What is the Technical Transfer (Process)?
M
e
n
u