30 Questions
What is the purpose of Process Validation?
To verify that a system performs as intended
What is the main objective of a Quality Audit?
To ensure compliance with regulations
What is the purpose of a Validation Protocol?
To provide a prospective experimental plan
What is Certification in the context of Validation?
A documented testimony of system qualification
What is the purpose of Phase III - Validation Maintenance?
To review process-related documents
What are the major types of Validation mentioned in the text?
Process validation, Cleaning validation, Equipment validation, and Validation of analytical methods
What is the primary purpose of maintaining master records of each batch?
To document each step in the production, control, packaging, labeling, and distribution of the product
What is the minimum time period for which master records of each batch must be maintained?
At least a year following the expiration date of a product batch
What is the purpose of identifying returned drug products by lot number?
To determine the product quality through testing
What happens to drug products that do not meet specifications?
They are not returned to the marketplace
What must be made available at the time of inspection by FDA officials?
All records
What is the purpose of maintaining complaint files regarding a drug product?
All of the above
What is the primary objective of pharmaceutical manufacturing?
To produce large quantities of drugs for distribution and sale
What is the main reason for the increase in extemporaneous compounding?
The need for customized medications for specific patients
What is a common characteristic of pharmaceutical manufacturing and extemporaneous compounding?
Both are regulated by cGMP
What is an example of a device that is covered by cGMP regulations?
Intrauterine devices
What is a common reason why patients require extemporaneous compounding?
All of the above
What is the purpose of cGMP regulations?
To ensure the quality and safety of medical devices
What is the primary purpose of a batch number?
To track the complete production history of a product
What information is typically included in a Master Batch record and Batch production record?
Product name, dosage form, batch size, list of each component, list of equipment used, calibration of instruments, and yield of final product
What is the purpose of the validation process in quality assurance?
To provide documented evidence of a process's consistency and quality
What is the main difference between a batch number and a lot number?
A batch number represents a specific production history, while a lot number represents a specific quantity of product
What phase of the validation process relates to drug development, pilot study, and scale-up?
Phase I - Pre-validation qualification
What is the primary purpose of a Master record?
To document the formulation, specifications, and manufacturing procedures of a product
What information is required by state law to be included on a prescription label?
The address of the patient
What is the purpose of including the 'indication' on the prescription label?
To help the pharmacist assure the prescribed drug is appropriate
What is typically included on an Over-the-Counter (OTC) medication label?
The name of the product, the name and address of the manufacturer or distributor, and the quantity of net contents
What information is required to be included on a prescription label in addition to the patient's name and directions for use?
The prescriber's name and the date of the prescription
What is the purpose of including the drug name, strength, and manufacturer's lot or control number on a prescription label?
To help the pharmacist ensure the correct medication is dispensed
What information is included in the 'drug facts' section of an Over-the-Counter (OTC) medication label?
The names and quantities of all active ingredients and inactive ingredients
This quiz covers the concepts of batch number, lot number, master record, and batch production record in pharmaceutical manufacturing. It tests your understanding of the differences between these terms and their importance in product identification and recall.
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