Save
Upgrade to remove ads
Busy. Please wait.
Log in with Clever
or
show password
Forgot Password?
Don't have an account?  Sign up 
Sign up using Clever
or
Username is available taken
show password


Make sure to remember your password. If you forget it there is no way for StudyStack to send you a reset link. You would need to create a new account. Your email address is only used to allow you to reset your password. See our Privacy Policy and Terms of Service.

Already a StudyStack user? Log In

Reset Password
Enter the associated with your account, and we'll email you a link to reset your password.
focusNode
Didn't know it?
click below
 
Knew it?
click below
Don't Know
Remaining cards (0)
Know
0:00
edit
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.

  Normal Size     Small Size show me how

QC 2 Lec

Documentations

QuestionAnswer
Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies Accelerated testing
The design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package size, are tested at all time points as in a full design. Bracketing
The four zones in the world that are distinguished by their characteristic prevalent annual climatic conditions Climatic zones
Production batches of a drug substance or drug product for which the stability studies are initiated or completed post approval through a commitment made in the registration application. Commitment batches
The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. Container closure system
A pharmaceutical product type (e.g., tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipients. Dosage form
The dosage form in the final immediate packaging intended for marketing. Drug product
The unformulated drug substance that may subsequently be formulated with excipients to produce the dosage form. Drug substance
Anything other than the drug substance in the dosage form Excipient
The date placed on the container label of a drug product designating the time prior to which a batch of the product is expected to remain within the approved shelf life specification. Expiration date
Long term and accelerated (and intermediate) studies undertaken on primary and/or commitment batches according to a prescribed stability protocol to establish or confirm the re-test period of a drug substance or the shelf life of a drug product. Formal stability studies
Containers that provide a permanent barrier to the passage of gases or solvents, e.g., sealed aluminum tubes for semi-solids, sealed glass ampoules for solutions. Impermeable containers
Studies conducted at 30°C/65% RH and designed to moderately increase the rate of chemical degradation or physical changes for a drug substance or drug product intended to be stored long term at 25°C. Intermediate testing
Stability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling. Long term testing
The process of adding together the assay value and levels of degradation products to see how closely these add up to 100% of the initial value, with due consideration of the margin of analytical error. Mass balance
The design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations is tested at a specified time point Matrixing
A single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance Mean kinetic temperature
An active pharmaceutical substance not previously contained in any drug product registered with the national or regional authority concerned. New molecular entity
A batch of a drug substance or drug product manufactured by a procedure fully representative of and simulating that to be applied to a full production scale batch. Pilot scale batch
A batch of a drug substance or drug product used in a formal stability study, from which stability data are submitted in a registration application for the purpose of establishing a re-test period or shelf life, respectively. Primary batch
A batch of a drug substance or drug product manufactured at production scale by using production equipment in a production facility as specified in the application. Production batch
The date after which samples of the drug substance should be examined to ensure that the material is still in compliance with the specification and thus suitable for use in the manufacture of a given drug product. Re-test date
The period of time during which the drug substance is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the drug substance has been stored under the defined conditions Re-test period
Containers that allow the passage of solvent, usually water, while preventing solute loss. Semi-permeable containers
The time period during which a drug product is expected to remain within the approved shelf life specification, Shelf life (also referred to as expiration dating period)
The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of a drug product at the time of its release Specification – Release
The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of a drug substance throughout its re-test period, or that a drug product should meet throughout its shelf life. Specification - Shelf life
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies. The equipment should be capable of controlling the storage condition within the ranges defined in this guideline. Storage condition tolerances
Studies undertaken to elucidate the intrinsic stability of the drug substance. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing. Stress testing (drug substance)
Studies undertaken to assess the effect of severe conditions on the drug product. Such studies include photostability testing Stress testing (drug product)
Data, other than those from formal stability studies, that support the analytical procedures, the proposed re-test period or shelf life, and the label storage statements. Supporting data
Created by: kateperryy
 

 



Voices

Use these flashcards to help memorize information. Look at the large card and try to recall what is on the other side. Then click the card to flip it. If you knew the answer, click the green Know box. Otherwise, click the red Don't know box.

When you've placed seven or more cards in the Don't know box, click "retry" to try those cards again.

If you've accidentally put the card in the wrong box, just click on the card to take it out of the box.

You can also use your keyboard to move the cards as follows:

If you are logged in to your account, this website will remember which cards you know and don't know so that they are in the same box the next time you log in.

When you need a break, try one of the other activities listed below the flashcards like Matching, Snowman, or Hungry Bug. Although it may feel like you're playing a game, your brain is still making more connections with the information to help you out.

To see how well you know the information, try the Quiz or Test activity.

Pass complete!
"Know" box contains:
Time elapsed:
Retries:
restart all cards