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level: COMPONENTS

Questions and Answers List

level questions: COMPONENTS

Question	Answer
Components of the Drug Product	1 Drug Substance 2 Excipients
forms the BASIS OF DESIGN for the development of the product.	Quality Target Product Profile
Considerations for the quality target product profile could include:	1 Intended use in clinical setting, route of administration, dosage form, delivery systems; 2 Dosage strength(s); 3 Container closure system 4 Therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics 5 Drug product quality criteria appropriate for the intended marketed product.
is a physical, chemical, biological, or microbiological property or characteristic that should be WITHIN AN APPROPRIATE LIMIT, range, or distribution to ensure the desired product quality.	Critical Quality Attributes
It is valuable science-based process used in quality risk management that can aid in identifying which material attributes and process parameters potentially have an effect on product Critical Quality Attributes Its tools can be used to identify and rank parameters (e.g., process, equipment, input materials) with potential to have an impact on product quality The list can be refined further through experimentation to determine the significance of individual variables and potential interactions. Once the significant parameters are identified, they can be further studied	Risk assessment
The RELATIONSHIP between the process inputs (material attributes and process parameters) and the critical quality attributes can be described in this can be described in terms of ranges of material attributes and process parameters, or through more complex mathematical relationships. TIME DEPENDENT function a combination of variables such as components of a MULTIVARIATE MODEL.	Design Space
The applicant can choose to establish independent design spaces for one or more __, or to establish a single design space that spans multiple __	unit operations, operations
is designed to ensure that a product of required quality will be PRODUCED CONSISTENTLY	Control Strategy
A control strategy can include, but is not limited to, the following:	1 CONTROL OF INPUT MATERIAL ATTRIBUTES based on an understanding of their impact on processability or product quality; 2 Product specification(s); 3 Controls for unit operations that have an impact on downstream processing or product quality 4 In-process or real-time release testing in lieu of end-product testing 5 A monitoring program for verifying multivariate prediction models.
can be monitored to ensure that it is working as anticipated to deliver product quality attributes as predicted by the design space.	Process Performance