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Questions and Answers
What is the purpose of Process Validation?
What is the purpose of Process Validation?
What is the main objective of a Quality Audit?
What is the main objective of a Quality Audit?
What is the purpose of a Validation Protocol?
What is the purpose of a Validation Protocol?
What is Certification in the context of Validation?
What is Certification in the context of Validation?
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What is the purpose of Phase III - Validation Maintenance?
What is the purpose of Phase III - Validation Maintenance?
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What are the major types of Validation mentioned in the text?
What are the major types of Validation mentioned in the text?
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What is the primary purpose of maintaining master records of each batch?
What is the primary purpose of maintaining master records of each batch?
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What is the minimum time period for which master records of each batch must be maintained?
What is the minimum time period for which master records of each batch must be maintained?
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What is the purpose of identifying returned drug products by lot number?
What is the purpose of identifying returned drug products by lot number?
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What happens to drug products that do not meet specifications?
What happens to drug products that do not meet specifications?
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What must be made available at the time of inspection by FDA officials?
What must be made available at the time of inspection by FDA officials?
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What is the purpose of maintaining complaint files regarding a drug product?
What is the purpose of maintaining complaint files regarding a drug product?
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What is the primary objective of pharmaceutical manufacturing?
What is the primary objective of pharmaceutical manufacturing?
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What is the main reason for the increase in extemporaneous compounding?
What is the main reason for the increase in extemporaneous compounding?
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What is a common characteristic of pharmaceutical manufacturing and extemporaneous compounding?
What is a common characteristic of pharmaceutical manufacturing and extemporaneous compounding?
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What is an example of a device that is covered by cGMP regulations?
What is an example of a device that is covered by cGMP regulations?
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What is a common reason why patients require extemporaneous compounding?
What is a common reason why patients require extemporaneous compounding?
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What is the purpose of cGMP regulations?
What is the purpose of cGMP regulations?
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What is the primary purpose of a batch number?
What is the primary purpose of a batch number?
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What information is typically included in a Master Batch record and Batch production record?
What information is typically included in a Master Batch record and Batch production record?
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What is the purpose of the validation process in quality assurance?
What is the purpose of the validation process in quality assurance?
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What is the main difference between a batch number and a lot number?
What is the main difference between a batch number and a lot number?
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What phase of the validation process relates to drug development, pilot study, and scale-up?
What phase of the validation process relates to drug development, pilot study, and scale-up?
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What is the primary purpose of a Master record?
What is the primary purpose of a Master record?
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What information is required by state law to be included on a prescription label?
What information is required by state law to be included on a prescription label?
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What is the purpose of including the 'indication' on the prescription label?
What is the purpose of including the 'indication' on the prescription label?
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What is typically included on an Over-the-Counter (OTC) medication label?
What is typically included on an Over-the-Counter (OTC) medication label?
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What information is required to be included on a prescription label in addition to the patient's name and directions for use?
What information is required to be included on a prescription label in addition to the patient's name and directions for use?
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What is the purpose of including the drug name, strength, and manufacturer's lot or control number on a prescription label?
What is the purpose of including the drug name, strength, and manufacturer's lot or control number on a prescription label?
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What information is included in the 'drug facts' section of an Over-the-Counter (OTC) medication label?
What information is included in the 'drug facts' section of an Over-the-Counter (OTC) medication label?
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