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The Medicine 2 - Sem 2 > Quality control > Flashcards

Quality control Flashcards

1
Q

What do quality and quality control mean?

A

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

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2
Q

Why is quality important?

A

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

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3
Q

What is capping?

A

is the detachment of a cross sectional fragment from the tablet face and is a direct result of lack of quality control

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4
Q

What are some parameters used to assess product quality?

A

disintegration, hardness, uniformity of content, dissolution, API stability, mean weight, loss on drying

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5
Q

Why are hardness and disintegration important parameters?

A

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

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6
Q

Why should methods to quantify parameters be validated?

A

to ensure measurements are accurate and precise

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7
Q

What methods are necessary to test that product is fit for purpose?

A

uniformity of content

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8
Q

What is important to ensure that tablet is safe & effective?

A

that all components evenly mixed and active component is present at the required dose in each tablet

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9
Q

To meet the requirements for uniformity of dosage units, each unit in a batch should have?

A

Known content of active component within a narrow range around label claim

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10
Q

Define the term uniformity of dosage units

A

the degree of uniformity in the amount of API compared to other dosage units

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11
Q

Uniformity can be measured by how many methods? – Explain them all including when they should be used

A

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

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12
Q

How are acceptance values determined for each method?

A

for CU it depends on the analytical method used and WV they are determined based on the number of samples tested

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13
Q

For solid dosage forms, how many units should be tested?

A

10 units

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14
Q

What is quality management?

A

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

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15
Q

Why is quality by design good?

A

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

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16
Q

What does quality control apply to?

A

all aspects from manufacture to the raw products, intermediate and final product

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17
Q

What should QC departments sample, test and document the quality of?

A

raw ingredients, intermediate products, final dosage form, pack, product pack, information about ingredients, instructions for storage and administration

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18
Q

What are the quality requirements of pharmaceutical products?

A

What are the quality requirements of pharmaceutical products?

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19
Q

What is the purpose of in-process testing?

A

to assure product integrity and batch uniformity, validate performance of manufacturing procedures, monitor output and quality of final product

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20
Q

Who are responsible for testing quality?

A

manufacturer’s QC department, other authorities such as BP, product specifications assessed by gov regulatory agency

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21
Q

BP monographs do not only define the tests and methods needed, but also what?

A

required sampling, levels of acceptance, levels of impurities etc

22
Q

What should analytical methods in QC ensure and specify?

A

accuracy, precision, repeatability, specificity, detection limit, quantitation limit, linearity and range of measurements

23
Q

What is specificity?

A

the ability to register only the desired analyte, while all other components in formulation do not affect the result

24
Q

What is sensitivity?

A

smallest amount of change in analyte that can be detected by a measurement

25
Q

Requirements should always have a set value and?

A

defined range of acceptance

26
Q

What should you consider when selecting the analytical method?

A

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)

27
Q

When would a proposed analytical test be rejected?

A

if you cannot detect the analyte in the required range of concentration and with the required precision

28
Q

Why is documenting required?

A

to prove that you have done all the necessary activities for that dosage forms and demonstrate adherence to methods in the BP monographs

29
Q

Name some things that should be included in the certificate of analysis

A

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

30
Q

What is counterfeit medicine?

A

a fake medicine that may contain the wrong or no active ingredient

31
Q

What are some characteristics of a counterfeit med?

A

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

32
Q

QA, GMP and QC are all key areas of what?

A

quality management system

33
Q

What is the difference between quality control and quality assurance?

A

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.

34
Q

What else does the quality management system deal with?

A

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.

35
Q

Discolouration is mainly due to what?

A

storage at wrong temp, humidity, light exposure

36
Q

What is the quality assurance department responsible for?

A

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

37
Q

What are quality assurance activities divided into and what’s the difference between the two?

A

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)

38
Q

What is the definition of good manufacturing practice?

A

a system in place to make sure the people and the products are adhering to requirements. GMP deals with documentation, labelling, cleanliness and training.

39
Q

What is the definition of good laboratory practice?

A

standards and protocols to regulate research/studies, similar to GMP but applies more to research-based activities. Promotes quality and validity of test data

40
Q

What is QbD?

A

an approach to control and constantly develop a manufacturing process in order to obtain consistent products

41
Q

How can you ensure quality by design?

A

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

42
Q

What are some GMP requirements?

A

all manufacturing processes clearly defined, all necessary facilities are provided

43
Q

What does GMP mainly focus on?

A

the layout of the site, identify equipment and define procedures to operate them

44
Q

Are quality control procedures included in GMP?

A

All manufacturing processes should be clearly defined, all necessary facilities are provided including: appropriately trained personnel, suitable equipment and services, adequate premises and space

45
Q

What are SOPs?

A

a sub class of instructions used to report all the procedures to put in place when running activities on the manufacturing site

46
Q

Who defines GMP requirements?

A

regulatory bodies

47
Q

Why should records be available and retained?

A

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

48
Q

Name some of the 10 GMP principles

A

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

49
Q

What are the 4 main components of GMP?

A

personnel, premises/equipment, hygiene & validation

50
Q

GLP helps scientists obtain results that are?

A

reliable, repeatable, auditable and recognised by scientists worldwide

The Medicine 2 - Sem 2 (14 decks)

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