Quality control Flashcards
What do quality and quality control mean?
Quality can be measured using different parameters, it’s essentially a measure of the degree of excellence of something and how it compares to things of a similar kind. Essentially it is the features/ characteristics of a product meet the requirement. Can be objective, subjective etc. Quality control concerns the procedures done to ensure the identity and purity of a particular pharmaceutical
Why is quality important?
it ensures drugs are safe and effective a process dedicated to sample, test and specify materials at each level of manufacturing. It determines if materials/products meet the requirements
What is capping?
is the detachment of a cross sectional fragment from the tablet face and is a direct result of lack of quality control
What are some parameters used to assess product quality?
disintegration, hardness, uniformity of content, dissolution, API stability, mean weight, loss on drying
Why are hardness and disintegration important parameters?
they are necessary to test that product is fit for purpose. Disintegration to determine how long till max conc of drug has been released and where in the GIT that will be
Why should methods to quantify parameters be validated?
to ensure measurements are accurate and precise
What methods are necessary to test that product is fit for purpose?
uniformity of content
What is important to ensure that tablet is safe & effective?
that all components evenly mixed and active component is present at the required dose in each tablet
To meet the requirements for uniformity of dosage units, each unit in a batch should have?
Known content of active component within a narrow range around label claim
Define the term uniformity of dosage units
the degree of uniformity in the amount of API compared to other dosage units
Uniformity can be measured by how many methods? – Explain them all including when they should be used
2 methods, content uniformity used for less potent drugs containing less than 25mg or 25% wt of active ingredient in formulation & weight variation is used for more potent drugs with more than 25mg or 25% wt active ingredient in formulation
How are acceptance values determined for each method?
for CU it depends on the analytical method used and WV they are determined based on the number of samples tested
For solid dosage forms, how many units should be tested?
10 units
What is quality management?
a system in place in pharmaceutical industries which is responsible for monitoring and certifying the quality of products. They must ensure that raw materials, intermediates and final products are sampled, tested and evaluated against BP spec
Why is quality by design good?
reduces chance of batch being rejected because it doesn’t meet requirements, meds can be produced in a controlled and consistent fashion which increases efficacy
What does quality control apply to?
all aspects from manufacture to the raw products, intermediate and final product
What should QC departments sample, test and document the quality of?
raw ingredients, intermediate products, final dosage form, pack, product pack, information about ingredients, instructions for storage and administration
What are the quality requirements of pharmaceutical products?
What are the quality requirements of pharmaceutical products?
What is the purpose of in-process testing?
to assure product integrity and batch uniformity, validate performance of manufacturing procedures, monitor output and quality of final product
Who are responsible for testing quality?
manufacturer’s QC department, other authorities such as BP, product specifications assessed by gov regulatory agency
BP monographs do not only define the tests and methods needed, but also what?
required sampling, levels of acceptance, levels of impurities etc
What should analytical methods in QC ensure and specify?
accuracy, precision, repeatability, specificity, detection limit, quantitation limit, linearity and range of measurements
What is specificity?
the ability to register only the desired analyte, while all other components in formulation do not affect the result
What is sensitivity?
smallest amount of change in analyte that can be detected by a measurement
Requirements should always have a set value and?
defined range of acceptance
What should you consider when selecting the analytical method?
Repeatability (min of 9 determinations at different concs and 6 at 100% conc), intermediate precision (Evaluate the effects of random events on the precision of the analytical method/procedure), Reproducibility (same analytical method/procedure should be validated inter-laboratory), Acceptance criteria (Numerical limits, ranges or other criteria defined for each test)
When would a proposed analytical test be rejected?
if you cannot detect the analyte in the required range of concentration and with the required precision
Why is documenting required?
to prove that you have done all the necessary activities for that dosage forms and demonstrate adherence to methods in the BP monographs
Name some things that should be included in the certificate of analysis
batch number, date of receipt, name and address of lab, expiry date or retest date, date test was completed, signature of the head of lab, shelf life
What is counterfeit medicine?
a fake medicine that may contain the wrong or no active ingredient
What are some characteristics of a counterfeit med?
manufactured with poor standard of GMP, packed in low quality packaging, contains incorrect quantity or strength of API, made using low quality excipients, contains wrong API
QA, GMP and QC are all key areas of what?
quality management system
What is the difference between quality control and quality assurance?
they are both part of the quality management systems, but QC aims at detecting product defects and monitoring the manufacturing products but QA aims at preventing it.
What else does the quality management system deal with?
Detection of defects in pharmaceutical products, Certification of the quality of products, Use of monographs to provide information about the quality of the medicinal product, Set the procedures (accordingly to policies, guidelines and regulations) that are designed to maintain products robustness and quality.
Discolouration is mainly due to what?
storage at wrong temp, humidity, light exposure
What is the quality assurance department responsible for?
Identify quality requirements of a product, as well as the responsible person to assess quality requirements, Maintain laboratories to the desired quality, such as maintenance of equipment, calibrated equipment against standards, Conform to pharmacopoeia material standards and methods, and use approved reference materials
What are quality assurance activities divided into and what’s the difference between the two?
technical (evaluate product documentation, perform or review quality control lab tests, monitor product performance) and managerial activities (select reliable suppliers, prepare contract terms, monitor supplier performance, perform inspection procedures)
What is the definition of good manufacturing practice?
a system in place to make sure the people and the products are adhering to requirements. GMP deals with documentation, labelling, cleanliness and training.
What is the definition of good laboratory practice?
standards and protocols to regulate research/studies, similar to GMP but applies more to research-based activities. Promotes quality and validity of test data
What is QbD?
an approach to control and constantly develop a manufacturing process in order to obtain consistent products
How can you ensure quality by design?
Consider formulation and process used to manufacture, identify which are high risk operations and what variables will impact them, have contingency plan to de-risk the possibility to have intermediate and final products lacking in quality and identify operations to add to the process and how you can modify the problematic variables
What are some GMP requirements?
all manufacturing processes clearly defined, all necessary facilities are provided
What does GMP mainly focus on?
the layout of the site, identify equipment and define procedures to operate them
Are quality control procedures included in GMP?
All manufacturing processes should be clearly defined, all necessary facilities are provided including: appropriately trained personnel, suitable equipment and services, adequate premises and space
What are SOPs?
a sub class of instructions used to report all the procedures to put in place when running activities on the manufacturing site
Who defines GMP requirements?
regulatory bodies
Why should records be available and retained?
to show that they’ve followed all the steps in the procedure and that they achieved the desired quality of the product & to enable the traceability of the movements of a batch
Name some of the 10 GMP principles
make sure you have the correct written instructions before starting a task, follow instructions precisely, correct equipment, prevent contamination & mix up, work accurately and precisely, ensuring you use the right equipment, ensure cleanliness, look out for mistakes and report them, make good records
What are the 4 main components of GMP?
personnel, premises/equipment, hygiene & validation
GLP helps scientists obtain results that are?
reliable, repeatable, auditable and recognised by scientists worldwide
