Quality Of Medicine

Question 0

What is quality assurance?

Answer 0

This is an determined and implemented set of procedures, that when followed correctly will determine whether the operation within an organisation produce products of an appropriate quality.

Question 1

What is quality?

Answer 1

Quality is fitness for purpose.
Each dose should contain the correct concentrations
Appearance should be elegant and consistent
Should behave as expected
Should contain no contaminants or degradation

Question 2

What is GMP?

Answer 2

Good manufacturing practice is a part of quality assurance,and ensures that products are consistently produced and controlled to th quality standards that have been determined to be appropriate for the products use.

Question 3

What is QC?

Answer 3

Quality control is a part of GMP, and thus part of QA, which is to do with the sampling and testing of products/procedures to ensure they are relevant, and that all requir procedures are being performed. This prevents any products that do not meet quality requirements are not release for sale or supply until they are judged satisfactory.

Question 4

What is GLP?

Answer 4

Documentation of any work during manufacture or testing of products, to make sur that appropriate information is documented.

Question 5

What is GCP?

Answer 5

Following documented procedures during evaluation of the medicine, and documentation of any evaluation and effects during any clinical trial.

Question 6

What are the essential parts of a QA system?

Answer 6

1. Quality assurance department to oversee all activities
2. Validated methods
3. Group to do development
4. Group to use methods
5. Group to check quality of products.

Question 7

What should be done to implement QA?

Answer 7

Written systems to control all aspects of development,production,evaluation and distrubution
Make sure sop is followed
Ensure training is adequate
Ensure facilities are suitable
Ensure all aspects are reviewed regularly
Ensure all audit is documented
Retain all documentation for the relevant length of time

Question 8

What is ISO9000 series?

Answer 8

International standards organisation, generic standard quality, assessed by ISO, applicable worldwide so shows a standard of quality.

Question 9

What are some of the organisations involved in quality assurance ?

Answer 9

MHRA - medicines and healthcare products regulatory authority
EMA European Medicines Agency
FDA food and drug administration
WHO world health organisation