Quality Control Tablet

  • Created by: LBCW0502
  • Created on: 25-10-18 20:58
What is quality control?
Refers to a procedure or set of steps taken during manufacturing of a product to ensure that it meets pharmacopoeia requirements and that the product is reproducible (barrier line to protect patient)
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What does quality mean?
A measure of excellence or a state of being free from defects, deficiencies and significant variations
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What is quality assurance?
Gaining confidence that required quality of the product or service if satisfactory for its intended use
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What is quality control part of?
Good Manufacturing Practice (GMP) - concerned with sampling, testing and specifications
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Describe the criteria for quality assurance - focus and goal
Prevent defects with focus on process. Improve development and test processes so defects don't arise
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Describe the criteria for quality assurance - how and what
Establish good quality management system/assessment of its adequacy with continuous monitoring. Prevention of quality problems through planned/systematic activities
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Describe the criteria for quality assurance - responsibility and tool
Involves everyone on the team. QA is a managerial tool
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Describe the criteria for quality control - focus and goal
Identify defects in finished product. Identify defects after product is developed and before it's released
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Describe the criteria for quality control - how and what
Find sources of quality problems to continually meet customer's requirements. Analytical techniques used to maintain product quality/process
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Describe the criteria for quality control - responsibility and tool
Specific team that tests products for defects. QC is a corrective tool
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Why is quality important in pharmaceuticals?
Essential operation of PI. Aim for consistent manufacture and deliver zero-defect products to patients. Objects include: efficacy, safety, quality and compliance
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Quality control is required for which three processes?
All raw materials/API and excipients (e.g. spectroscopy, titration, HPLC assays, differential scanning calorimetry). Packaging (contact with drug tested, visual appearance, spectroscopy, loss on drying). Finished product (HPLC, dissolution, CU)
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Which two processes are likely to be carried out in the same area?
Raw materials and finished product (PI). Packaging components involved in supply areas
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State the features of the impact of ignoring medicine quality
Manufacturing process, packaging, transportation, storage condition. Lack of therapeutic effect: toxic/adverse reaction, waste of limited financial resources, loss of credibility
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State the features of the impact of ignoring medicine quality - variations in manufacturing
Materials (variation of same substance), batch-to-batch variability from same supplier, variations within same batch
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State the features of the impact of ignoring medicine quality - variations in machinery
Variation of equipment for the same process, difference in adjustments required, age of machine and maintenance
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Describe features of quality metrics
IPSE. Measurement standard by which efficiency, performance, progress compliance, quality of process, product assessed. Key performance indicators identified based on impact on organisation goals and quality. Communication to top management
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Give examples of KPIs
Batch failures, market complaints, deviations, changes, stability issues (need developments to improve failed KPIs)
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What is the difference between accuracy and precision?
Accuracy relates to how close the measured value is to the true value. Precision relates to the measure of dispersion around the measured value (e.g. analogy of target board)
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What is a pharmacopeia?
Focus on quality of products using tools of analytical sciences. Achieve global harmonisation of quality specifications (APIs, excipients, dosage forms), increases globalisation/reciprocal collaboration. Legally binding (national/regional)
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Describe features of the International Pharmacopoeia
Issued by WHO. Aims to provide international standards which are less technical. Adopted by member states. Help to achieve global uniformity of quality specifications
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Describe features of the British Pharmacopoeia
Statutory component in control of medicines. Complements/assists licensing and inspection processes of MHRA with BNF. Defines UK's pharmaceutical standards
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Describe features of pharmacopeia quality control tests for solid dosage forms (tablets and capsules)
Tablets: uniformity of dosage units, dissolution test, disintegration test, resistance to crushing, friability. Capsules: uniformity of dosage units, dissolution test
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Describe features of uniformity of dosage units
CU and MV. Consistency of dosage form of units. Each unit in batch should have API content within narrow range around label claim. CU (destructive/wet chemical analysis)
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Give examples of non-destructive tests
Near Infrared Spectroscopy (NIR), MV
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Outline the process for uniformity of dosage units - CU
30 units. Measure drug content of 10 units. Calculate dose as % of label claim (accuracy). Calculate arithmetic mean as SD of 10 doses (% of label claim). Calculate AV (<15.0). Make sure no single value if <0.75M or >1.25M
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Outline the process for uniformity of dosage units - MV
30 units. Assay content of drug. Calculate % of label claim. Weight 10 units. Calculate arithmetic mean and SD of 10 weight values. Use equation to calculate estimated content for each dosage form. Calculate X, s and AV. Check batch (pass/fail)
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Which table should be referred to when looking at uniformity of dosage forms?
Table 2.940-2 in BP
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What is disintegration?
Physical process related to mechanical breakdown of a tablet into smaller particles/granules
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Outline the in vitro disintegration test
Place dosage form in an immersion medium under defined experimental conditions, measure time taken for dosage form to disintegrate. Time in which dosage form disintegrates is defined in monograph.
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Describe features of in vitro disintegration - procedure for uncoated tablets
6 tablets chosen. Tubes vertically raised/lowered for 30 times/min in water batch (37 degrees Celsius). Pass if all 6 tablets completely disintegrate within specified time. Fail if any tablet hasn't disintegrated. Various parameters/different tablets
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What is dissolution?
Process by which a solid enters into a solution
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Describe features of the in vitro dissolution test
Requirement for all solid oral dosage forms. Used in phases of development for product release/stability testing. Key analytical test to detect physical changes in API and in formulated product
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Outline the in vitro dissolution test - procedure for immediate release dosage forms
Place 1 unit into 6 dissolution beakers (paddles/rotations). Withdraw samples at 45 mins. Replace volume with equal amount of buffer. Determine amount of API in sample. Pass (>70% dissolved by 45 mins). Fail - further 6 tablets tested (need to pass)
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Describe features of resistance to crushing of tablets
Crushing strength (hardness) - minimum diametric compressional force which fractures a tablet. Tablet diameter/thickness affect force necessary to break it. Tensile strength (equation)
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Which units are used for crushing strength measurements?
Kg, N and pounds
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Outline the procedure for crushing strength measurements (1)
10 random tablets placed between jaws of instrument (note orientation, shape, break marks, inscriptions). Apply pressure/measure force at break. Express results - mean force (N). Provide max/min force measured, info - instrument/tablet orientation
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Outline the procedure for crushing strength measurements (2)
Calculate tensile strength of each tablet and mean/SD
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What is friability?
Resistance to abrasion. % weight loss resulting from chipping, abrasion and erosion of tablets under stress conditions
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Outline the procedure for friability measurements (1)
If single tablet weights <0.65g, select 20 random tablets. If single tablet weight >0.65g, select 10 random tablets. Tablets dedusted, weighed, placed in Perspex drum, tumbled (rotate 100 times). Reweigh tablets
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Outline the procedure for friability measurements (2)
Pass if <1% friability (<0.1% realistic). If >1%, repeat twice. Mean weight loss of all three repeats must be <1% to pass (application - research about breaking tablets in half, also practice Qs - see lecture notes)
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Other cards in this set

Card 2

Front

What does quality mean?

Back

A measure of excellence or a state of being free from defects, deficiencies and significant variations

Card 3

Front

What is quality assurance?

Back

Preview of the front of card 3

Card 4

Front

What is quality control part of?

Back

Preview of the front of card 4

Card 5

Front

Describe the criteria for quality assurance - focus and goal

Back

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