MDM: Quality1

Question 1

What is quality?

Answer 1

A product that is fit for purpose: The right medicine for the right person that is safe and effective.

• The right drug
• Right dose
• released in the right place
• at the right time
• in a bioavailable form
• no contaminents
• suitable for patient

Question 2

What is Quality Assurance?

Answer 2

Wide ranging concept which convers all matters which influence the quality of the product. It is the sum total of the organised arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use.

Question 3

What is the good manufacturing practice (GMP)

Answer 3

that part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation or product specification

Question 4

What is quality Control?

Answer 4

“that part of GMP. Ensure that the necessary and relevant tests are actually carried out and that materials are not release for use, nor products release for sale or supply, until their quality has been judged to be satisfactory.”

Question 5

What are examples of systems used to assure the quality of medicines?

Answer 5

• Good laboratory practice
• Good clinical practivce
• Good manufacturing practice

Question 6

What is good laboratory practice?

Answer 6

• Doccumentation of work carried out during the development and evaluation of medicines
• Doccumentation of analysis of the medicines during and following production process

Question 7

What is good clincial practice?

Answer 7

• Following doccumented proccedures during the clincial evaluation of a medicine
• Doccumentation of the evaluation of a medicine including any effects experienced by test subjects

Question 8

What is good manufacting practice

Answer 8

• Following doccumented proceedures and using the correct materials to make a medicine which meets the specifications as stated by the marketing authorisation
• Doccumentation and witness of all actions that occur during the process production

Question 9

Why do we need to follow doccumented proceedures?

Answer 9

• Reproducibility
• The ability to be confident that what is in the packet is what is stated on the packet

Question 10

Why do we need to assure the quality of a medicine

Answer 10

• Prevent harm to patient and ensure it works
• uphold the imagine of the company who developed and manufatured the product
• to protect the professional integraty of the pharmacist

Question 11

What are the requirements of a quality assuracne system?

Answer 11

• Quality assurance department - over sees all activites
• Validated methods for all departments
• development department
• production department
• quality control department

Question 12

How is QA implemented?

Answer 12

• Ensure written systems in place to control all aspects of development, production, evaluation and distribution
• Ensure all written proceedures followed
• Ensure staff adequetly trained and kept up to date
• Ensure facilities suitable and maintained
• ensure all aspects checked on a regular basis to comply with audits
• ensure audits doccumented
• ensure all doccumentation kept for the required lenght of time

Question 13

What staff are required to implement a QA system?

Answer 13

• Quality manager - ensures all proceedures and systems comply with appropriate GxP
• Qualified person - acess complicane with QA. Rejects or approves batches of medicinal products depending on compliance
• production manager - over sees production facility and ensures QA process are being adhered too
• Quality control manager - over sees testing facilities to ensure all QA process are being adhered too and all testing complies with procedures outlined

Question 14

What QA systems are currently in place?

Answer 14

• IS9000
• pharmaceutical quality assurance

Question 15

What quality improvements is there?

Answer 15

• Total quality management - integrated effort to improve quality at every level of the organisation
• Quality by design - quality can’t be put into a product by testing, needs to be put in at start
• 6 sigma - a system for the evaluation of processes to ensure that 99.9999998% of all products meet the specification, by reducing waste and improving yield.

Question 16

What organisations are involed?

Answer 16

• MHRA
• WHO
• ICH