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Exam 4

Terms in this set (16)

What is the FDA Mantra?
If it's not documented, it didn't happen
Quality assurance helps prevent quality issues through process-oriented methods. True or False?
True
Process validation establishes scientific evidence that a process is capable of consistently delivering quality product. True or False?
True
Which of the following Codes of Federal Regulation outlines how pharmaceutical companies need to record data and keep track of records?
CFR 21 Part 11
The outbreak of fungal meningitis in steroid injection produced by the New England Compounding Center led to the establishment of Kefauver-Harris Drug Amendments. True or False?
False
Shipping Studies should consider both minimum and maximum load scenarios. True or False?
True
Which of the following type of validation often leads to the transfer of manufacturing process from development phase to production phase?
Prospective
Which of the following type of audit reviews actions of the manufacturer undertaken in response to the violation of cGMP observed during a previous audit?
Compliance Audit
Process validation includes checking the product at one specified time and location within the production process. True or False?
False
Which of the following is involved in determining the standards used to coordinate cGMP and regulations?
Location of manufacturer
Location of intended use
Which of the following type of drug application is submitted for the approval of a generic drug product?
Abbreviated New Drug Application
Which of the following aspect of quality management system is in place to ensure that only current documents are being used by all personnel?
Document Control
Shipping studies help us understand the effect of shipping on the package design. True or False?
True
Which of the following is true about planned deviations?
The deviation must not affect the final quality of the product.
The following utilizes historical data to provide evidence that a process performs as claimed.
Retrospective validation
Which of the following type of audit occurs after a manufacturer submits a new product to the FDA?
Pre-Approval Audit
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