QC and QA compliance

Question 1

What is QA?

Answer 1

All matters influencing quality of product.

Question 2

What does a QA system ensure?

Answer 2

Products are designed and developed to GMP
Controls on the environment
Controls on starting, intermediate and finished products
Operators competent to perform functions
Correct system for release
Storage & distribution consistent with shelf life
Pharmaceutical quality system operates

Question 3

What are the requirements of QC?

Answer 3

1. adequate facilities, trained personnel, and approved procedures are available
2. samples are taken from all parts of the process and retained samples kept for future testing
3. test methods are validated
4. records made of sampling and deviations
5. qualitative and quantitative tests comply with label
6. participate in investigations of complaints

Question 4

A BSC/HLFC can be used to manufacture sterile MPs in what level backgroud?

Answer 4

Grade B background (as isolators are open fronted)

Question 5

A Isolator can we used with what level background to manufacture sterile products?

Answer 5

Grade D background

Question 6

How is air monitored in a clean room?

Answer 6

Known volume of air (typically 1m3) using impaction/centrifugal forces.
(This can cause physical stress to bacteria) It is important to not interchange instrument design (as some cause more stress than others)

Question 7

Are settle plates a passive or active QC technique

Answer 7

Passive

Question 8

What are the advantages of settle plates?

Answer 8

No physical stress to bacteria.

Simple to measure, easy and cheap

Question 9

What are the disadvantages of settle plates?

Answer 9

Only represents

Question 10

Why should contact plates contain a neutraliser?

Answer 10

To stop any pick up of disinfectant which may prevent any microbes from growing

Question 11

Why is it important to wash work surface after plating with contact plate?

Answer 11

Agar will act as food for any existing bacteria

Question 12

Why is sterility testing not often carried out in aseptics?

Answer 12

Sterility test takes 14 days - don’t usually have this much time, as often making personalised medicines close to the time of administration.

Question 13

What are the main issues associated with syringe leakage?

Answer 13

Droplets between the seals
Gross failure beyond both deals
Acceptance criteria

Question 14

What is dead space and what can it result in?

Answer 14

Dead space at syringe entrance up to 0.2ml. Addition of a needle leads to double dead-space. Can lead to incorrect amount of drug.

Question 15

What are the consequences of air in syringe?

Answer 15

Risk of air embolism in patient
Incorrect volume of solution
Implications for stability and infusion rate

Question 16

What are the consequences of drug in bung?

Answer 16

Risk of contamination to user as seal has been compromised.
Integrity of the syringe has been compromised exposing the contents of syringe to microbiological contamination .
Risk of exposure to cytotoxic drugs
Creates a fluid pathway for microbiological contamination into the solution.