QA- Lec 2

Question 1

Bad days and disasters

Answer 1

• Missed pharmaceutical practicals
  
  • The day you were all organised, but I can not believe all the things that went wrong
  • My alarm did not go off

Question 2

Dispensing error

Answer 2

• There was a locum doctor
• The surgery computer was down so he hand wrote the Rx
• The prescriber got the dose wrong which confused
• The patients friend collected the prescription
• They got the wrong drug

Question 3

Swiss cheese model of errors

Answer 3

• Holes due to active failures
• Other holes due to latent conditions
• Every so often
• all the defences in place fail (all holes line up) and the hazard turns into an accident

Question 4

Eu legislation- Eudaralex

Answer 4

• 10 volumes- including
  
  • Vol 2 notice to applicants and regulatory guidelines for medicinal products for human use
  • Vol 10 guidelines for clinical trials
  • Vol 4- Guidlines for good manufacturing practice for medicinal products for human and veterinary use

Question 5

Vol 4- GMP guidelines

Answer 5

• Intro
• Part I- basic requirements for medicinal products- chap 9
• Part II- Basic requirements for API
• Part III- GMP related documents
• Annexes- 19 total

Question 6

EC guide to GMP characters

Answer 6

Question 7

EC guide to GMP part II and III

Answer 7

Question 8

EC guide to GMP annexes

Answer 8

Question 9

Pharmaceutical quality systems

Answer 9

• Terms and definitions
  
  • Quality management (QM) / Quality assurance (QA)
  • Good manufacturing practice (GMP, cGMP)
  • Quality control (QC)
  • Product quality review (PQR)
  • Quality risk management (QRM)

Question 10

Quality assurnace/ management

Answer 10

• Everything that make a product fit for use
• Including
  
  • Production
  • Research and development
  • Quality control (QC)
  • Training
  • Documentation

Question 11

QA/QM

Answer 11

• Quality management is a wide-ranging concept
• Which covers all matters, which individually or collectively influence the quality of a product
• It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use
• QA therefore incorperated GMP

Question 12

GMP

Answer 12

• Ensures that products are reproducibly manufactured fit for use
• Consistency
• Quality
• Intened for use
• Concerns production and QC

Question 13

QC

Answer 13

• Testing and all associated with testing and final product release
• Testing of final product release
• Quality has been judged to be satisfactory

Question 14

QC control department

Answer 14

• Quality control is sometimes used in the sense of the organisation entity which has the responsibility of these functions

Question 15

Product quality review

Answer 15

• Regular review, usually annually, of a finished product or a range of finished product
• Should include
  
  • Starting materials
  • In-process checks
  • Out of specifications deviations, complaints
  • Change
  • Ongoing stability studies

Question 16

Quality risk management

Answer 16

• Systematic process to:
  
  • Assessment, control communicate, review RISKS
• Principles of QRM are
  
  • Based on scientific knowledge, process experience, protects the patient
  • Level of effort is commensurate with the level of risk

Question 17

QA/GMP/QC inter-relationship

Answer 17

• QA
• GMP- part of QA
• QC- part of GMP- testing and release
• PQR= part of QC
• QRM= effects all area’s so we have to think about at each stage

Question 18

Quality assurance some contributing processes

Answer 18

1. Documentation
2. Product development
3. Provess
4. GLP
5. Environment
6. Raw material
7. In-process testing
8. End-product testing
9. Audit

Question 19

The 7 pillar model

Answer 19

• Training
• Document control
• Validation
• Change control
• Maintenance
• Control of purchase
• Self inspection
• Roof of building is the overall goals
• Without foundations (post surveillance systems-YELLOW CARD) or pillars (general quality system) overall goals collapse

Question 20

Medicinal products

Answer 20

• Full product licence
  
  • MRHA licence for specific products
• Pharmaceutical specials
  
  • Manufactured in a MHRA licensed unit to the specification of the prescriber
• Dispensed
  
  • Prepared under the supervision of a pharmacist in a registered pharmacy
  • Sec 10 exemption of the 1968 medicines act

Question 21

Medicines can be

Answer 21

• Licensed
  
  • MA (product license)
  • Specific formulation, manufacturing method, licensed manufacturer
• Unlicensed
  
  • Prescribers clinical freedom
  • Patient with special needs- often very elderly or young

Question 22

Unlicensed medicines

Answer 22

• Medicines for patients special needs
  
  • Imported into the UK that are licensed abroad but not licensed in the UK
  • Imported into the UK that are not licensued abroad or in UK
  • Licensed in the UK, but not used for their licensed indication (off label)
  • Prepared as specials by licensed manufacturers but do not hold marketing authorisations
  • Dispensed medicines (sec 10)- under the supervision of a pharmacist

Question 23

Section 10- dispensing

Answer 23

• Dispensing against a prescription
• Tablet packs
• Extemporaneous dispensing

Question 24

Responsibility- The qualified person

Answer 24

• Each batch of finished product must be certified by a QP within the EC/EEA before being released for sale or supply in the EC/EEA or for export
• Members of: RPS of GB; Institute of biology; Royal society of chemists
• Relevant body of knowledge: See websites; courses
• Suitable experience: Product license
• Viva- representative from each society

Question 25

Responsibility- The qualified person

Answer 25

* Finished product certification before release * Manufactured and tested in accordance to the MA * Manufactured under GMP * Directs and recall's