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10 Cards in this Set

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Q: What is the highest monetary settlement in FDA history?
A: $500 million. In 2002, Schering-Plough agreed to a consent decree that obligated the company to pay a $500 million fine. The consent decree resulted from FDA finding significant GMP violations at several Schering-Plough facilities. (http://www.fda.gov/bbs/topics/NEWS/2002/NEW00809.html)
Consent decree
Q. How many prescription drugs were recalled in fiscal year 2003 (the most recent year for which data is available)?
A. 254 prescription drugs were recalled in fiscal year 2003. GMP deviations was among the top ten reasons for drug recalls in 2003. In fact, GMP deviations has ranked among the top ten reasons for drug recalls in each of the past five years! (http://www.fda.gov/cder/reports/rtn/2003/rtn2003.htm)
How many GMP inspections were conducted by FDA in fiscal year 2003 (the most recent year for which data is available)?
FDA conducted 1,512 good manufacturing practice inspections in fiscal year 2003. (http://www.fda.gov/cder/reports/rtn/2003/rtn2003.htm)
FDA and its European counterpart, the EMEA, have a confidentiality agreement allowing them to share documents related to product quality, including inspection reports and product test sample reports. True or false?
True. The confidentiality agreement was signed in 2003. (http://www.emea.eu.int/pdfs/general/direct/pr/Letter%20to%20EC%20and%20EMEA.pdf)
According to 21 CFR 211.100(b), “Any deviation from the written procedures shall be [blank] and [blank].”
Recorded and justified. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm)
Verbs
FDA requires that drug company employees must receive GMP training at least once per year. True or false?
False. The regulation is not that specific. According to 21 CFR 211.25(a), GMP training must be conducted “on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.” (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm)
In 2002, FDA adopted a systems-based approach for drug cGMP inspections. What are the six systems defined in the program?
Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, Laboratory Control System. When conducting a drug cGMP inspection, FDA will inspect two or more of these six systems: the Quality System and at least one other system. (http://www.fda.gov/cder/dmpq/compliance_guide.htm)
Under the FDA’s systems-based approach for drug cGMP inspections, a firm is considered out of control if two or more systems are out of control. True or false?
False. According to the FDA’s Compliance Program Guidance Manual, “A firm is out of control if any one system is out of control. A system is out of control if the quality, identity, strength and purity of the products resulting from that/those system(s) cannot be adequately assured. Documented CGMP deficiencies provide the evidence for concluding that a system is not operating in a state of control.” (http://www.fda.gov/cder/dmpq/compliance_guide.htm)
FDA recently acknowledged that “problems in physical design, characterization, manufacturing scale-up and quality control routinely derail or delay development programs and keep needed treatments from patients.” True or false?
True. This statement was included in a white paper published in March 2004 by FDA. The white paper outlined various ways in which FDA is trying to help speed up the development of new drugs and devices. For example, the white paper mentions that FDA has undertaken “an extensive, multi-year effort to incorporate the most up-to-date science into its regulation of pharmaceutical manufacturing and to encourage industry to adopt innovative manufacturing technologies.” (http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html)
The ICH process results in requirements that are mandatory in the U.S. True or false?
False. The ICH process results in guidance documents. Because guidances are not regulations or laws, they are not enforceable. (http://www.fda.gov/cder/audiences/iact/iachome.htm)