Documents & Records
The organization with the authority to review all documentation associated with the product of a drug or device product, including SOPs, calibration records, validation files, and all other files that contribute to the "written history" of the product
The FDA
What requires adequate space for placement of equipment and must be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations?
Facility Design
THIS type of risk management provides numerical assignment of risk
Quantitative Risk Management
Which organization's guidelines are divided into these four categories: Quality, Safety, Efficacy, Multidisciplinary
ICH
(International Council for Harmonisation)
Quality Policy
The location that describes the amount of time a record must be kept according to regulatory & local requirements
The Document Retention Schedule
This aspect of FUE is essential to proper product quality, especially true for inspection stations
Lighting
Risk Management should begin and be continued throughout THIS to fully help characterize the product and process
Product Lifecycle
The term used to describe the characterized drug product and process during development, and the limits and justifications for such
Design Space
Which Quality Subsystem only applies after a product has been commercially launched?
Post-Market Surveillance
The single most important purpose of GDP (Good Documentation Practices)
Activity Recreation
All ____________ that could affect product quality should be qualified and appropriately monitored and action should be taken when limits are exceeded
Utilities
Which Regulatory or Standards document provides the current guidelines for Quality Risk Management?
ICH Q9 Quality Risk Management
What is a core element of QbD that identifies concerns in advance and develops appropriate mitigation strategies?
Quality Risk Management (ICH Q9)
Where are CGMP regulations documented that are binding and have the force and effect of law?
Code of Federal Regulations (CFR)
The document that defines objective, measurable characteristics of a product, product component, or critical quality process
Specification Document
THIS is prevented when a facility is designed to keep product and components from intermingling
Product Mix Up
The level of effort, formality and documentation of the quality risk management process should be THIS
Commensurate with the risk
This ICH guidance has three primary objectives: 1) Achieve product realization, 2) Establish and Maintain a state of control, and 3) Facilitate continual improvement
ICH Q10- Pharmaceutical Quality System
We ___________ to regulations and we ___________to standards and guidances.
Comply, Conform
The Section of the 21 CFR 211 titled "Written Procedures; Deviations"
Equipment, Filters, and Lubricants all must be considered with regards to ________________ when determining if the setup is of proper design and able to prevent product contamination. (Hint: stability testing and extractable/leachable testing would detect contamination is insufficiently controlled)
Product Contact
Modern control strategies are used to do THIS when there is a well characterized drug product and process
Mitigate Risks
What Quality process demonstrates that a process meets the critical quality attributes and is consistently able to achieve the expected outcome?
Validation
An organized, documented system for reviewing all changes to assess their impact on manufacturing or product
Change Control