Pharmaceutical quality 3

Question 1

What is GMP?

Answer 1

• Is one component of the
  broad regulatory framework utilised by the pharmaceutical industry.
• Its primary objective is ensuring that quality is maintained throughout the
  process.

Question 2

What are the key components of the GMP?

Answer 2

• 1. Quality Management
• 2. Personnel
• 3. Premises and Equipment
• 4. Documentation
• 5. Production
• 6. Quality Control
• 7. Contract Manufacture and Analysis
• 8. Complaints and Product Recall
• 9. Self Inspection

Question 3

Briefly explain quality management.

Answer 3

• The manufacturer must produce products that are fit for their intended use and do not place patients at risk.

Question 4

What is meant by personnel?

Answer 4

• A satisfactory system of Quality Assurance
  depends on people.
• There must be sufficient qualified personnel to
  carry out the necessary tasks.

Question 5

How are premises and equipment important for pharm quality?

Answer 5

• The layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance.

Question 6

What does documentation prevent?

Answer 6

• Errors from spoken communication

Question 7

What must production follow?

Answer 7

• Clearly defined procedures and should be performed only by trained and competent people

Question 8

What are quality control activities concerned with?

Answer 8

Sampling, specifications and testing and ensure than products are not released for sale or distribution before their quality has been judged satisfactory

Question 9

What is contract manufacture?

Answer 9

• where a third party manufacturer performs some activities on behalf of the original manufacturer

Question 10

How is compliance achieved?

Answer 10

By having an effective quality management system

Question 11

What does the quality unit consist of?

Answer 11

Quality Assurance and Quality Control and must be independent of production

Question 12

What does QC carry out?

Answer 12

Analytical testing and checks that specifications are met for raw materials,
intermediates and final products

Question 13

What does QA ensure?

Answer 13

That all aspects of the organisation’s quality management systems are maintained

Question 14

What does a QP mean?

Answer 14

A Qualified Person - a licensed pharmacist, biologist or chemist
- Regulations specify that no batch of medicinal Proust can be released for sale or supply prior to certification by a QP

Question 15

State the characteristics of a licensed medicine.

Answer 15

• Clinical and toxicological data
• Stability data
• Analytical method development
• Process development
• Issue ML
• Marketing
• Global sales

Question 16

State the characteristics of unlicensed medicines.

Answer 16

• Single patient use
• Controlled by MHRS Guidance Note 14
• Prescriber has full responsibility
• No stability data-1 months shelf life
• Can’t copy something licensed
• Often no finished product testing

Question 17

What are key features of specials manufacture?

Answer 17

• Simple but effective methods on batch sheets
• Standard Operating Procedures
• Perform risk assessments
• In house risk mitigation techniques to prevent errors