Quality of pharmaceuticals Flashcards
What is the pharmaceutical definition of quality?
conformance to requirements
What does conformance to requirements mean?
your product or medicines should comply with the et standards
What is the 6 sigma quality?
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
What is required to achieve level 6 of the six sigma quality?
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
Why should error be minimised?
prevention (of an error) is better than cure (rectifying the error)
Why must certain standards and goals be set up to measure quality?
changes in quality can be subjective. you can’t directly measure it but you can measure the products against the standards and goals
what are pharmaceuticals?
compounds and chemicals which have significant effect on the health of individuals
What is the importance of quality in pharmaceuticals?
quality ensures medicines that reach the patient are of a safe, effective and appropriate quality
What does quality in pharmaceuticals require?
a comprehensive quality assurance programme requiring both technical and managerial tasks.
what do technical tasks include?
- preparing the documents about the specification,
- tests on raw materials,
- conducting the lab tests at each and every step.
What do managerial tasks include?
- 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.
where are the standards and guidelines for quality published?
in the standard pharmacopoeias
what is particular about quality in the pharmaceuticals?
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.
Why must testing be done at each and every step of the drug production?
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
what are the two main parameters when determining a good quality pharmaceutical?
safety and efficacy
what other parameters do you use to determine the quality of the medicine?
identity purity: potency uniformity: bioavailability stability
Why is identity of the medication tested?
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
why is the purity of the medicine tested?
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
why is potency tested?
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
Why is uniformity tested?
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.
Why is bioavailability tested?
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
why is stability tested?
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
what are the consequences of poor quality?
less desired therapeutic effect
toxic/adverse side reactions
chance of death
economoical effects like loss of credibility of healthcare system
Who is responsible for quality?
management suppliers production department quality control people contract laboratories distribution networks pharmacists regulatory agencies
What are management responsible for?
they are the leaders.
defining quality standards
Seeing standards & objectives have been commnicated with the team properly and effectively
what are the suppliers responsible for?
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
what are the production department responsible for?
checking for cross contamination and mix ups.
making sure everything follows procedures
what are quality control people responsible for?
see if standards are followed properly starting from raw materials
ensuring and testing all standards and specifications
what are contract laboratories responsible for?
abiding by the guidance and standards from companies for the orders
what are distribution networks responsible for?
storing medicines and dosage forms in the correct conditions to minimise degradation
what are pharmacists responsible for?
we are the link between the medicine and consumer
we must not sell bad quality medicines
what are regulatory agencies responsible for?
making sure that guidelines have been followed at each step
what is quality assurance?
the sum total of all procedures to ensure quality.
it ensures pharmaceutical products are of the required quality, desired safety and efficacy
what does quality assurance involve/require?
-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)
What is good manufacturing practice?
Practice that ensures products are consistently manufactured to an appropriate standard, it is concerned with both manufacturing and quality control procedures
What is the relationship between quality control and good manufacturing practice?
QC is a part of the GMP
What else is quality control concerned with?
- 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)
what do quality control have the authority to do?
recall the product if at any stage they decide something does not comply with the standards
What are the different good practices?
good clinical practice
group laboratory practice
good manufacturing practice
current good manufacturing practice
What is GCP?
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
What is GLP?
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
What are the main components of the GLP study?
Plan Perform Monitor Record Archive Report
What is the main purpose of the GLP?
safety identity strength purity quality
these can only be achieved if everyone understands the importance of GLP
What is the GMP?
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
What do GMP’s require?
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,
Who is responsible in controlling GMP in NZ?
medsafe
What do the GMP cover?
People Plant Products Processes Paperwork
What are cGMPs?
current good manufacturing practices
These are current GMPs in case there are any immendements, e.g. new technology
how is a cGMP certificate obtained?
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,
