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Pharmacy Year 2 Semester 2 > Quality control > Flashcards

Flashcards in Quality control Deck (31)
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1
Q

Definition of quality - subjective

A

Attribute, characteristic, or property of a thing or phenomenon that can be observed and interpreted, and may be quantified but cannot be measured e.g. beauty, feel, flavour, taste.

2
Q

Objective definition of quality

A

Measurable and verifiable aspect of a thing or phenomenon, expressed in numbers or quantities, such as lightness or heaviness, thickness or thinness, softness or hardness.

3
Q

Manufacturing definition of quality

A

Strict and consistent adherence to measurable and verifiable standards to achieve uniformity of output that satisfies specific customer or user requirements.

4
Q

ISO definition of quality

A

the totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs.

5
Q

Definition of pharmaceutical quality

A

“ The term quality control refers to the procedures undertaken to ensure the identity and purity of a particular pharmaceutical. Such procedures may range from simple chemical experiments e.g. screening for the presence of particular pharmaceutical substance, to more complicated requirements of pharmacopoeial monographs.

6
Q

Quality managements

elements and explanation of the elements

A

Quality Assurance - Wide range concept covering all matters that influence the quality of a product

Good manufacturing process: ensures that products are produced and controlled to meet appropriate quality standards

Quality control: is a process dedicated to sample, test and specify materials at each end level of manufacturing, determining if they meet the requirements

7
Q

Pharmaceutical quality

list of aspects

A

Identity: existence of API(s) indicated on the label;
Purity: no harmful contaminants, no cross-contamination;
Strength or potency: API(s) content range [90-110], ensuring long shelf life;
Uniformity of the dosage form in: consistency, colour, shape, size of tablets/capsules, etc.;
Bioavailability: speed and completeness with which the pharmaceutical enter the bloodstream;
Stability: the medicine should retain its properties until the expiration date.

8
Q

examples of poor quality

A

-A poor quality medicine may contain toxic substances that have been added unintentionally.

A medicine that contains little or none of the claimed active ingredient will not have the intended therapeutic effect.

9
Q

Anti-counterfeit packaging

A

Counterfeit is a problem of product security!
Counterfeiting products, packaging or product-pack means producing replica of the originals, products which are not controlled as authentic ones.
With reference to packaging, counterfeit can act as:
Duplication: copying labels, packaging, products, instructions and usage information;
Substitution: placing products of low (or not controlled) quality in authentic or reused packaging;
Tampering: by altering packages/labels and using not controlled products in place as real;

10
Q

anti-counterfeit - medicines

A

problem of poor quality control
Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They couldhave the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health.
FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation’s drug supply from the threat of counterfeits.[1]

11
Q

Counterfeit medicines can act as

A

With reference to medicines, counterfeit can act as:
May contain no API(s)
May contain the wrong API(s), e.g. cheap vs expensive
May contain an incorrect quantity of the API(s), e.g. low
May be included in a low-quality packaging
May be manufactured using low-quality API(s) or excipients
May be manufactured under poor standards of good manufacturing practice (GMP) compliance

12
Q

Importance of quality control

list

A

-correct and dosed ingredients
-Labels: instructions, expiration date, storage and ingredients
-number of items per pack
-packaging requirements
etc

13
Q

Quality control in medicines

A

Quality is tested by the manufacturer’s Quality Control department,
Quality of products must be checked also by other authorities e.g. British Pharmacopoeia
Product specifications are assessed by the government regulatory agency
Monographs can be used to provide information about the quality of the medicinal product.

14
Q

Where is quality control performed at?

A

Quality Control is performed at:
Suppliers (materials)
Manufacturing levels (production)

15
Q

Quality control department -examples of things checked

A

Raw materials are examined to make sure they meet the appropriate specifications;
Partially completed products are also analysed (correct production processes);
Finished pharmaceutical products are tested to determine if the requirements are met.
Suitable packaging specifications are issued (pack-product requirements);
Stability tests are performed to determine product’s shelf-life and storage conditions.

16
Q

Drug development process

A
Synthesis
Biological testing
Chemical development
Product development
Process development
Package development
Stability
Clinical trials
Drug approval 
Manufacture: large scale production
17
Q

Chemical development

A

Design the synthesis method for the drug as raw material, with the most economical and safest large scale production.
Identity:
infrared spectroscopy, ultraviolet spectroscopy, nuclear magnetic resonance spectroscopy, mass spectroscopy
Strength:
assay, iodine value, saponification value
Quality:
pH, optical rotation, specific gravity, viscosity, and refractive index
Purity:
solubility, melting point, boiling point, loss on drying, residue on ignition, readily carbonisable substances, congealing range, sulfate, chloride, heavy metals, arsenic, lead, foreign matter, and known impurities
Physical Properties:
colour, taste, texture, crystallinity, description

18
Q

Define accuracy

A

the sense of trueness and precision.

19
Q

Define specificity

A

the ability to register only the desired analyte, while all other components in the formulation do not influence the results.

20
Q

Define sensitivity

A

the smallest absolute amount of change in analyse that can be detected by a measurement.

21
Q

Questions to answer when accuracy testing

A

Questions to answer:
Is a substance present or not?
In which range of concentration is the substance present?
Does the concentration lie far from a verifiable threshold limit?
Has the threshold limit been exceeded?
In what concentration, ± confidence interval, is the substance in question present in the sample?

22
Q

QC at prototyping level

A

From its discovery, the new drug is produced in a variety of dosage forms, e.g. tablet, capsule, cream, liquid syrup, injectable solution, etc.
In its dosage form, the drug substance is usually mixed with excipients, e.g. filler, binder, lubricant, disintegrant, etc.

Quality Control tests designed to test the purity of materials in small batches

23
Q

QC at small-scale production

A

Quality Control tests designed to optimise and validate the production

Review of formulation for the new equipments used.
Review of validation methods for large scale production.
Evaluation of the process in which materials are compounded into dosage form(s) is complex and efficient: all quality requirements are here considered.

24
Q

QC of drug metabolism/pharmacokinetics

A

Develop analytical techniques for measuring compound and metabolite concentrations in tissues
Determine major metabolites in relevant test species
Determine PK parameters in test species

25
Q

QC safety assessment

A

Safety pharmacology
In vitro toxicology
Short- and Long-term animal tests

26
Q

QC clinical development

A

Phase I: assessment of PK characteristics and side effects in normal volunteers
Phase II: dose-finding and efficacy tests in small groups of patients
Phase III: definitive trials of efficacy in large groups of patients

27
Q

3 main QC steps and what they are

A
  • sampling
  • testing
  • documentation
28
Q

Sampling SPC method

A

Statistical Process Control (SPC) methods:
extend the use of descriptive statistics to monitor the quality of the product and process.
are used to make sure production stays within this normal range.
quickly detect the occurrence of identifiable causes of quality variation in the production process.

Control charts are the most commonly used tool for monitoring a production process, showing whether a sample can be classified within the required range of variation.
By collecting data from samples at different points within the process, process variations that may affect the quality of the finished product can be detected and corrected, thus reducing waste (and costs) as well as customer’s risks.

29
Q

Acceptance sampling

A

Acceptance sampling is a form of Statistical Quality Control that involves random testing of samples from lots or batches either before ore after a manufacturing process.
Note: The test is always performed against standards.
Acceptance Sampling plans: single, double or sequential sampling plan;
Acceptance/Rejection criteria are based on: the size of the lot, the number of tested samples and the level of confidence to attain (requirements);
The operating characteristic (OC) curve is used to determine the probability of accepting a lot given various proportions of defects in a lot.

30
Q

Testing quality of finished product

A

Assay the API(s) and other ingredient(s), if appropriate, to match Quality Standards.
Medicine homogeneity e.g. uniformity of content in tablets and capsules of ingredient(s).
Release of the active ingredient from the formulation (to match with bioavailability requirements).
Microbiological tests e.g. sterility tests for injectable and ophthalmic products.

31
Q

Documentation of QC

A

Registration number of the sample (batch number)
Date of receipt
Name and address of the laboratory testing the sample
Name and address of the originator of the request for analysis
Name, description, and batch number of the sample (where appropriate)
Name and address of the original manufacturer
Reference to the specification used for testing the sample
Results of all tests performed (mean and standard deviation, if applicable) with the prescribed limits
Conclusion as whether or not the sample was found to be within the limits of the specification
Expiry date or retest date, if applicable
Date on which the test(s) was (were) completed
Signature of the head of laboratory or other authorised person