Pharmaceutical Production Records

What is the purpose of Process Validation?

To generate documents for quality audit
To verify that a system performs as intended (correct)
To plan for equipment calibration
To ensure compliance with regulations

What is the main objective of a Quality Audit?

To ensure compliance with regulations (correct)
To certify a system's qualification
To plan for process validation
To evaluate the performance of a system

What is the purpose of a Validation Protocol?

To provide a prospective experimental plan (correct)
To generate documents for quality audit
To plan for equipment calibration
To ensure compliance with regulations

What is Certification in the context of Validation?

A documented testimony of system qualification (C) Signup and view all the answers

What is the purpose of Phase III - Validation Maintenance?

To review process-related documents (C) Signup and view all the answers

What are the major types of Validation mentioned in the text?

Process validation, Cleaning validation, Equipment validation, and Validation of analytical methods (D) Signup and view all the answers

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 (B) Signup and view all the answers

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 (D) Signup and view all the answers

What is the purpose of identifying returned drug products by lot number?

To determine the product quality through testing (B) Signup and view all the answers

What happens to drug products that do not meet specifications?

They are not returned to the marketplace (D) Signup and view all the answers

What must be made available at the time of inspection by FDA officials?

All records (D) Signup and view all the answers

What is the purpose of maintaining complaint files regarding a drug product?

All of the above (D) Signup and view all the answers

What is the primary objective of pharmaceutical manufacturing?

To produce large quantities of drugs for distribution and sale (C) Signup and view all the answers

What is the main reason for the increase in extemporaneous compounding?

The need for customized medications for specific patients (A) Signup and view all the answers

What is a common characteristic of pharmaceutical manufacturing and extemporaneous compounding?

Both are regulated by cGMP (D) Signup and view all the answers

What is an example of a device that is covered by cGMP regulations?

Intrauterine devices (B) Signup and view all the answers

What is a common reason why patients require extemporaneous compounding?

All of the above (D) Signup and view all the answers

What is the purpose of cGMP regulations?

To ensure the quality and safety of medical devices (A) Signup and view all the answers

What is the primary purpose of a batch number?

To track the complete production history of a product (C) Signup and view all the answers

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 (A) Signup and view all the answers

What is the purpose of the validation process in quality assurance?

To provide documented evidence of a process's consistency and quality (A) Signup and view all the answers

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 (A) Signup and view all the answers

What phase of the validation process relates to drug development, pilot study, and scale-up?

Phase I - Pre-validation qualification (C) Signup and view all the answers

What is the primary purpose of a Master record?

To document the formulation, specifications, and manufacturing procedures of a product (A) Signup and view all the answers

What information is required by state law to be included on a prescription label?

The address of the patient (D) Signup and view all the answers

What is the purpose of including the 'indication' on the prescription label?

To help the pharmacist assure the prescribed drug is appropriate (C) Signup and view all the answers

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 (B) Signup and view all the answers

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 (C) Signup and view all the answers

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 (B) Signup and view all the answers

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 (B) Signup and view all the answers