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48 Terms
Who is promptly informed of recalls?
Consignees, authorities, distribution/warehouse, and manufacturer
What does 21 CFR 211.142 refer to?
Holding and Distribution
What is the purpose of Good Distribution Practices (GDP)?
Ensure drugs are stored, handled, distributed, and remain safe and traceable
What does GDP stand for?
Good Distribution Practices
Who can drug products be delivered to?
Authorized entities such as licensed wholesalers and pharmacists
What information is required for an effective recall?
Lot number, product, strength, dosage form
What does QU stand for?
Quality Unit (QA + QC)
Who must approve change control before implementation?
Quality Unit (QU)
Who can initiate change control?
The company internally or regulatory authorities
What are change controls used for?
Proactive improvements and corrective actions
What does VCR stand for?
Validation Change Request
Changing manufacturing equipment is classified as what type of change?
Major change
Who ensures compliance with the Quality System?
Management Representative
What prevents counterfeit drug products?
Serialization
What validates an operator if they cannot be directly validated?
Education, training, and experience
What regulation supports 21 CFR 211.110?
21 CFR 211
How many stages are in process validation?
Three
What are the three stages of process validation?
Process Design, Process Qualification, Continued Process Verification
Which validation stage proves the process produces consistent quality?
Process Qualification
Which stage involves ongoing monitoring of manufacturing?
Continued Process Verification
What does CPV stand for?
Continued Process Verification
What is the goal of Continued Process Verification?
Ensure ongoing validation and consistent product quality
Which validation stage includes R&D and Quality by Design?
Process Design
Major validation projects and requalification are what type of activities?
Project-based activities
What does Quality by Design focus on?
Reducing variability and improving yield
What is the focus of Six Sigma?
Reducing variation and defects in processes
What does a higher Sigma level indicate?
Fewer defects and better quality
What does ICH stand for?
International Council for Harmonisation
What four areas does ICH focus on?
Quality, Identity, Purity, Strength
Is Quality by Design universally mandatory in the EU and Japan?
No, it is a recommended regulatory approach
What did the FDA's cGMPs for the 21st Century initiative promote?
Integration of quality systems and risk management
What formula defines risk in quality systems?
Probability × Severity
What are the 8 analytical validation parameters?
Linearity, selectivity, accuracy, bias, calibration model, precision, intermediate precision, reproducibility
What are examples of Quality System concepts?
CAPA, change control, risk management
Can method validation only be created electronically for analytical processes?
No
What does the triangular diagram represent?
The four elements of equipment qualification
What is the purpose of method validation?
Confirm the method is fit for its intended use
Is validation clearly defined in 21 CFR 210 and 211?
No
What verifies accuracy of sample analysis?
Analytical Method Validation
What is validation?
Collection and evaluation of data from process design through commercial production
During which qualification stage do you determine if equipment upgrades are needed?
Design Qualification
What is the correct order of equipment qualification?
DQ → IQ → OQ → PQ
Serial number, functionality, and product description belong to which qualification stage?
Installation Qualification
What caused the Dextrose IV contamination incident at Davenport Hospital?
Miscommunication about autoclave protocol
Who reviews and approves validation documents?
Validation Review Board
What does AIQ stand for?
Analytical Instrument Qualification
What does AIQ ensure?
Analytical instruments and procedures are suitable and properly documented
If an absorption peak appears at the wrong time in flow cytometry what should be done?
Troubleshoot the instrument and consider requalification