Lecture 3 Flashcards
What is Quality by Design (QbD), and how is it achieved?
QbD stands for “Quality by Design.” It ensures quality throughout the product lifecycle by validating the manufacturing process to maintain consistency and safety.
How is “quality” defined in the context of drug products?
Quality is “fitness for intended purpose.” A drug is fit for purpose when it:
Is the correct product with proper formulation and identity
Has the right concentration
Is effective and free from contamination
Is safe for patient use
What are the consequences of failures in microbiological quality?
Public Health Risks: Illness or death from contaminated products
Bad Publicity: Damage to reputation
Litigation: Lawsuits from affected individuals
Financial Costs: Destruction of contaminated batches
Loss of Export Opportunities: Restricted export capabilities to certain countries
What is the role and responsibility of the microbiology lab?
Leads contamination control efforts
Ensures accurate and consistent test results
Conducts investigations to control contamination
Serves as the “microbiological conscience” of the company
What are the problems with relying on end-product microbiological testing?
It is retrospective, revealing issues only after production
Limited sample size since tests are destructive
Restricted testing range, as not all contaminants can be tested
Delayed results due to long incubation times
High warehousing costs because batches must be quarantined
Why is end-product testing still done?
Provides necessary documentation for batch release
Required by regulatory authorities
Confirms the effectiveness of control measures
What is the aim of a Microbiological QA/QC Programme?
The aim is to minimize or eliminate microbial contamination. This is achieved by:
Preventing contamination during production
Monitoring all control measures
Performing sterility testing on sterile products
Releasing products with proper certificates of analysis or quality
