Lecture 17_ Quality Assurance Flashcards
(18 cards)
How is QA different from Quality Control (QC)?
QC tests materials and products after production. QA is broader—quality is built into processes from the beginning, not tested in afterward
What is the Pharmaceutical Quality System (PQS)?
A comprehensive system incorporating GMP and quality risk management, ensuring quality objectives are achieved consistently
What is Quality by Design (QbD)?
A proactive approach where quality is designed into the product/process from the start using science and risk-based tools
What is Process Analytical Technology (PAT)?
A system for real-time monitoring and control of manufacturing processes to ensure product quality
What is the PIC/S guide?
A harmonised GMP guide adopted by TGA and other global regulators, originating from WHO GMP guidelines
What is ICH?
The International Council for Harmonisation—sets global guidelines for pharmaceutical quality (e.g., ICH Q8–Q12)
Name three key ICH guidelines related to quality.
Q8: Pharmaceutical Development, Q9: Quality Risk Management, Q10: Pharmaceutical Quality System
When is GMP required?
GMP is required for commercial production and investigational medicinal products (IMPs), but not typically for preclinical or early clinical work
What is an Investigational Medicinal Product (IMP)?
A drug used in clinical trials.
What are Material Attributes?
Properties of raw materials (e.g. particle size, sterility) that impact product quality
What is a Critical Process Parameter (CPP)?
A process variable (e.g., temperature, pH) that directly affects a Critical Quality Attribute (CQA) and must be controlled
What is a Control Strategy?
A planned set of controls (process parameters, materials, testing) to ensure consistent product quality
What are the different types of packaging?
Primary (direct contact, e.g. vials), secondary (outer packaging, e.g. boxes), tertiary (bulk packaging for shipping)
What are container closure considerations?
Must be inert, compatible with the drug, and tested for leachables, sterility, and stability
What is a Drug Substance (DS)?
The active pharmaceutical ingredient (API) before formulation into the final product
What is a Drug Product (DP)?
The finished dosage form containing the drug substance and excipients
What must be validated in the manufacturing process?
At least 3 batches, including 1/10 of commercial scale, must be fully characterised to register the product
What types of analytical testing are used on drug products?
Includes identity, assay (HPLC), degradation, host cell contaminants, pH, viscosity, and sterility tests
