Quality of pharmaceuticals

Question 1

What is the pharmaceutical definition of quality?

Answer 1

conformance to requirements

Question 2

What does conformance to requirements mean?

Answer 2

your product or medicines should comply with the et standards

Question 3

What is the 6 sigma quality?

Answer 3

a scale which is now a widely accepted tool to improve quality.
it is based on identifying defects and taking actions to prevent them.
It is divided into 6 levels where 6 sigma is the highest quality

Question 4

What is required to achieve level 6 of the six sigma quality?

Answer 4

you should not produce more than 3.4 defects or errors out of a million products to ensure you cna deliver a 99.99% quality

Question 5

Why should error be minimised?

Answer 5

prevention (of an error) is better than cure (rectifying the error)

Question 6

Why must certain standards and goals be set up to measure quality?

Answer 6

changes in quality can be subjective. you can’t directly measure it but you can measure the products against the standards and goals

Question 7

what are pharmaceuticals?

Answer 7

compounds and chemicals which have significant effect on the health of individuals

Question 8

What is the importance of quality in pharmaceuticals?

Answer 8

quality ensures medicines that reach the patient are of a safe, effective and appropriate quality

Question 9

What does quality in pharmaceuticals require?

Answer 9

a comprehensive quality assurance programme requiring both technical and managerial tasks.

Question 10

what do technical tasks include?

Answer 10

• preparing the documents about the specification,
• tests on raw materials,
• conducting the lab tests at each and every step.

Question 11

What do managerial tasks include?

Answer 11

• choosing the right suppliers,
• constantly communicating with them to make sure they are providing the right product each time.
• frequent checks on the suppliers to make sure they provide the same materials and quality.

Question 12

where are the standards and guidelines for quality published?

Answer 12

in the standard pharmacopoeias

Question 13

what is particular about quality in the pharmaceuticals?

Answer 13

Quality of pharmaceuticals cannot be judged by consumer,
customers can’t judge if its pure etc They can only judge if the medication is effective,
The effect of medicine is also quite dependent on the individual,

It is up to the formulation scientists and manufactures to check the quality of the pharmaceuticals.

Question 14

Why must testing be done at each and every step of the drug production?

Answer 14

it is not just the quality of the final product we have to ensure.
The raw materials, process of manufacturing, packaging and labelling also needs to be of high quality, and checked i,e, assurance requires multiple steps.
we must also be able to prevent, and detect cross contamination

Question 15

what are the two main parameters when determining a good quality pharmaceutical?

Answer 15

safety and efficacy

Question 16

what other parameters do you use to determine the quality of the medicine?

Answer 16

identity
purity: 
potency
uniformity: 
bioavailability
stability

Question 17

Why is identity of the medication tested?

Answer 17

if a medicine claims to have a therapeutic purpose, its active ingredient MUST BE PRESENT.
we test this to make sure no labelling errors have been made and that the medicine is in fact what it is

Question 18

why is the purity of the medicine tested?

Answer 18

no chemical entity is 100% pure but its purity should be within set limits so that it is able to produce its claimed therapeutic effect

Question 19

why is potency tested?

Answer 19

potency is the measure of drug activity of which it has been labelled. i.e. whether the a certain amount of active ingredient can produce the desired effect.
this should be tested to ensure it meets its claim

Question 20

Why is uniformity tested?

Answer 20

This increases patient acceptability.

for example, in solid dosage forms like tablets, you need them to be all equal, and not one bigger than another.

Question 21

Why is bioavailability tested?

Answer 21

bioavailability determines how much active ingredient reaches the circulation to produce an effect and depends on formulation and excipients etc.
This affects the dosage and frequency of dose of the medicine to produce its desired therapeutic effect so must be tested

Question 22

why is stability tested?

Answer 22

the extent of degradation needs to be within the specified limit to ensure there is enough active ingredient to produce the desired therapeutic effect within a period of time.

the product should also be stable enough to withstand certain conditions

Question 23

what are the consequences of poor quality?

Answer 23

less desired therapeutic effect
toxic/adverse side reactions
chance of death
economoical effects like loss of credibility of healthcare system

Question 24

Who is responsible for quality?

Answer 24

management
suppliers
production department
quality control people
contract laboratories
distribution networks
pharmacists
regulatory agencies

Question 25

What are management responsible for?

Answer 25

they are the leaders. defining quality standards Seeing standards & objectives have been commnicated with the team properly and effectively

Question 26

what are the suppliers responsible for?

Answer 26

providing good quality raw materials provide right quality product with specifications and certification of analysis may also be suppliers of packaging materials which also need to be of high quality

Question 27

what are the production department responsible for?

Answer 27

checking for cross contamination and mix ups. | making sure everything follows procedures

Question 28

what are quality control people responsible for?

Answer 28

see if standards are followed properly starting from raw materials ensuring and testing all standards and specifications

Question 29

what are contract laboratories responsible for?

Answer 29

abiding by the guidance and standards from companies for the orders

Question 30

what are distribution networks responsible for?

Answer 30

storing medicines and dosage forms in the correct conditions to minimise degradation

Question 31

what are pharmacists responsible for?

Answer 31

we are the link between the medicine and consumer | we must not sell bad quality medicines

Question 32

what are regulatory agencies responsible for?

Answer 32

making sure that guidelines have been followed at each step

Question 33

what is quality assurance?

Answer 33

the sum total of all procedures to ensure quality. it ensures pharmaceutical products are of the required quality, desired safety and efficacy

Question 34

what does quality assurance involve/require?

Answer 34

-review and approval of procedures (unless these have been done you cannot continue with the development of the product) -review of associated costs -audit checks timely and routinely to determine -whether standards and procedures are followed overseeing trend analysis evaluations (of errors to prevent recurrence)

Question 35

What is good manufacturing practice?

Answer 35

Practice that ensures products are consistently manufactured to an appropriate standard, it is concerned with both manufacturing and quality control procedures

Question 36

What is the relationship between quality control and good manufacturing practice?

Answer 36

QC is a part of the GMP

Question 37

What else is quality control concerned with?

Answer 37

- sampling specification and testing - batch release (critical step which requires big decisions) - determination of sample size, - determination of quality control tests - how the sample should be recorded - documenting the QC test in a proper report - checking parameters (including appearance, solubility, level of impurity)

Question 38

what do quality control have the authority to do?

Answer 38

recall the product if at any stage they decide something does not comply with the standards

Question 39

What are the different good practices?

Answer 39

good clinical practice group laboratory practice good manufacturing practice current good manufacturing practice

Question 40

What is GCP?

Answer 40

good clinical practice: In clinical trials there are standards involving: taking info from patient participants, the safety of patient and volunteers before and after the study proper design of study who conducts it how the steps of the study are conducted, data collection, method of analysis these studies can be audited if their duration is 1-2 years

Question 41

What is GLP?

Answer 41

good laboratory practice: this applies to all analytical and toxic labs includes: all procedures & principles in all labs studies to be performed at a particular procedure at a particular standard

Question 42

What are the main components of the GLP study?

Answer 42

``` Plan Perform Monitor Record Archive Report ```

Question 43

What is the main purpose of the GLP?

Answer 43

``` safety identity strength purity quality ``` these can only be achieved if everyone understands the importance of GLP

Question 44

What is the GMP?

Answer 44

Good manufacturing practice. These often come into place following a tragic incident. 1937: sulphanilamide 1941: phenobarbitone 1960: thalidomide They are a set of regulations, codes and guidelines for the manufacture of drug substances and drug products in vivo and in vitro diagnostic products and food

Question 45

What do GMP's require?

Answer 45

They require that the manufacturers and packagers of drugs, medical devices, some food and blood have to ensure that their products are safe, pure and effective before marketing,

Question 46

Who is responsible in controlling GMP in NZ?

Answer 46

medsafe

Question 47

What do the GMP cover?

Answer 47

``` People Plant Products Processes Paperwork ```

Question 48

What are cGMPs?

Answer 48

current good manufacturing practices | These are current GMPs in case there are any immendements, e.g. new technology

Question 49

how is a cGMP certificate obtained?

Answer 49

First a company needs some standards, they then train their people to those standards and document all procedures, Then an external body comes and audits it, Once you have given them the answers and they are satisfied, you can get the certificate and start manufacturing,