QA- Lec 2 Flashcards
1
Q
Bad days and disasters
A
- 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
2
Q
Dispensing error
A
- 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
3
Q
Swiss cheese model of errors
A
- 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
4
Q
Eu legislation- Eudaralex
A
- 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
5
Q
Vol 4- GMP guidelines
A
- Intro
- Part I- basic requirements for medicinal products- chap 9
- Part II- Basic requirements for API
- Part III- GMP related documents
- Annexes- 19 total
6
Q
EC guide to GMP characters
A

7
Q
EC guide to GMP part II and III
A

8
Q
EC guide to GMP annexes
A

9
Q
Pharmaceutical quality systems
A
- 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)
10
Q
Quality assurnace/ management
A
- Everything that make a product fit for use
- Including
- Production
- Research and development
- Quality control (QC)
- Training
- Documentation
11
Q
QA/QM
A
- 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
12
Q
GMP
A
- Ensures that products are reproducibly manufactured fit for use
- Consistency
- Quality
- Intened for use
- Concerns production and QC
13
Q
QC
A
- Testing and all associated with testing and final product release
- Testing of final product release
- Quality has been judged to be satisfactory
14
Q
QC control department
A
- Quality control is sometimes used in the sense of the organisation entity which has the responsibility of these functions
15
Q
Product quality review
A
- 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
16
Q
Quality risk management
A
- 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
17
Q
QA/GMP/QC inter-relationship
A
- 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

18
Q
Quality assurance some contributing processes
A
- Documentation
- Product development
- Provess
- GLP
- Environment
- Raw material
- In-process testing
- End-product testing
- Audit
19
Q
The 7 pillar model

A
- 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

20
Q
Medicinal products
A
-
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
21
Q
Medicines can be
A
- Licensed
- MA (product license)
- Specific formulation, manufacturing method, licensed manufacturer
- Unlicensed
- Prescribers clinical freedom
- Patient with special needs- often very elderly or young
22
Q
Unlicensed medicines
A
- 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
23
Q
Section 10- dispensing
A
- Dispensing against a prescription
- Tablet packs
- Extemporaneous dispensing
24
Q
Responsibility- The qualified person
A
- 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
25
Q
Responsibility- The qualified person
A
- Finished product certification before release
- Manufactured and tested in accordance to the MA
- Manufactured under GMP
- Directs and recall’s