Pharmaceutical quality 1

Question 1

Why do we need regulation?

Answer 1

• We all want safe and effective treatments
• We want to know that drugs have been
  developed in a safe and ethical manner.

Question 2

What do regulators do?

Answer 2

• Ensure than animal studies comply with Good Laboratory Practise
• Clinical trials comply with Good Clinical Practice
• Drugs are manufactures under current Good Manufacturing Practice

Question 3

What is the role of the US FDA?

Answer 3

Regulates drug products within the USA
- Ensures drugs are produced and marketed in accordance with the regulatory requirements

Question 4

What does the FDA regulate?

Answer 4

1. Drugs
2. Biologics
3. Medical devices
4. Food
5. Animal feed and drugs
6. Cosmetics
7. Radiation emitting products

Question 5

What does CDER do?

Answer 5

Centre for Drug Evaluation and Research
- Overseas the research, development, manufacture and marketing of small drug molecules

Question 6

What does CBER do?

Answer 6

Centre for Biologics Evaluation Research
- regulates the following:
1. Viral-vectored gene insertions
2. Drugs composed of human or animal cells
3. Allergen patch tests
4. Allergenics
5. Antitoxins
6. In vitro diagnostics
7. Vaccines
8. Blood, blood products and tissue for transplantation

Question 7

State the factors that ensure pharmaceutical quality.

Answer 7

• Product Design – including dose level and delivery
  rate to patient.
• API and excipient sourcing and purity.
• Primary and Secondary pack design including
  security.
• Security of supply chain from ingredients through
  to the pharmacy shelf.

Question 8

What is quality control?

Answer 8

• The laboratory testing of materials using analytical techniques to determine whether the result is within the specification limit

Question 9

What is quality assurance?

Answer 9

• A wide-ranging concept covering all matters that individually or collectively influence the quality of a product
• Describes a documentation review of all aspects of the product development and manufacture

Question 10

What are the major areas pharmaceutical quality is divided into?

Answer 10

1. Development
2. Quality control
3. Production
4. Distribution
5. Inspections

Question 11

What is the ISO 9000?

Answer 11

• A series of standards, developed and published by the International Organisation for Standardisation (ISO)that define, establish and maintain an effective quality assurance system for manufacturing and service industries

Question 12

What is verification (testing)?

Answer 12

External check of equipment accuracy

Question 13

What is calibration?

Answer 13

Equipment is adjusted based on comparison to certified or known reference materials

Question 14

What is a log book used for?

Answer 14

Record all pertinent operating parameters