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PY365 Quality Of Sterile Medicines > Sampling and Quality control > Flashcards

Sampling and Quality control Flashcards

1
Q

what are the steps taken to ensure compliance

A
  1. HACCP and GMP
  2. ICH adherence and standardised manufacture, incorporating process testing
  3. quality control, calibration and sound measurements in respect of error and variation
  4. sampling- from capture to strategy and planning
  5. process analytics, recovery of sample and cleaning validation
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2
Q

who is the founder of good manufacture

A

GMP or cGMP

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3
Q

what is HACCP

A

hazard analysis of critical control points
- basis for safety

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4
Q

what does HAZOP stand for

A

Hazard and operability study

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5
Q

what do the ICH guidelines aim to address

A

aim to address concerns of producing the medicine

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6
Q

where are production concerns covered in ICH guidelines

A

ICH Q7 and Q11

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7
Q

where are HACCP and HAZOP addressed in ICH guidelines

A

ICH Q9

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8
Q

what does Q1 cover in ICH guidelines

A

product stability

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9
Q

what does Q2 cover in ICH guidelines

A

analytical methodologies

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10
Q

what does Q3 cover in ICH guidelines

A

contaminants

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11
Q

what does Q4 cover in ICH guidelines

A

Pharmacopoeias, compendia

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12
Q

what does Q5 cover in ICH guidelines

A

biological and biotech products

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13
Q

what does Q6 cover in ICH guidelines

A

specifications

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14
Q

what does Q7 cover in ICH guidelines

A

good manufacturing practice

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15
Q

what does Q9 cover in ICH guidelines

A

risk management (HACCP)

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16
Q

what does Q10 cover in ICH guidelines

A

quality systems

17
Q

what does Q11 cover in ICH guidelines

A

manufacturing of drug substances

18
Q

What does HACCP consist of

A
  • points of weakness
  • points of loss of control
  • points of external influence
    flagged up notifiers at these points
  • involves testing point analysis as part of a regime of quality control
19
Q

outline the 7 point system of HACCP

A
  1. conduct a hazard analysis
  2. establish critical control points based on decision tree
    - temperature, time, pH, particle size
  3. establish critical limits/thresholds so that each CCP has 1 or more limits
  4. establish procedure to monitor CCPs
  5. establish corrective action in event of exceeded limits
  6. record keeping, full documentation
  7. verification of findings in terms of effective working of HACCP policy
20
Q

give examples of limits used in HACCP

A

content of drug, impurities, toxins, microbes

21
Q

what are the advantages of the documentation process

A
  1. regulatory compliance
  2. validation and assurance
  3. legal protection
22
Q

what are the disadvantages of the documentation process

A

bureaucracy

23
Q

what are the advantages of using a formal guide

A
  1. reduction of systematic error
  2. fulfilment of a licence requirement
24
Q

name the key activities used in quality control

A
  1. physical sampling
  2. statistical testing
  3. routine in and on process tests
25
Q

how is physical sampling used in quality control

A
  1. confidence and reproducible sample recovery
  2. lab tests using valid analytical methods (VAM)
  3. system suitability
26
Q

Give examples of routine in and on process tests

A
  1. magic eye- metal, colour, obscuration, smart materials
  2. rapid tests- impedance/DEFT, limit tests (chemical analysis), product history markers
  3. manual sorting
27
Q

what process aids can be used

A
  1. magic eye technologies for on-line/in-line/at-line testing
  2. light beam magnetic field- transmission reflection, interruption, barcode reading
28
Q

Why is calibration performed

A
  1. standard purity
  2. consistency
  3. reliability and trueness of results
  4. compatibility with other data
  5. removes systematic error
  6. maximises capabilities of equipment and technologies
29
Q

what is standard deviation

A

the root of variance and lies at the heart of measured quantity variation

30
Q

what is experimental variance

A

the sum of individual contributions

31
Q

what is meant by propagation of errors

A

errors can be additive or multiplicative
- additive- routine variability
- multiplicative- multifactor driven increasing change

32
Q

what are sampling regimens

A
  • physical capture of a representative sample
  • physical sampling is associated with quality control
  • strategy for sampling is associated with manufacturing
33
Q

describe how a sample pot is used

A
  1. plastic containers are taken into production area for sampling purposes
    - glass is generally not allowed due to risk of contamination of product by shards
  2. the compounds that can leach out of non inert plastic sample containers are:
    - bisphenol A, which is used in tough polycarbonate products (antioxidant)
    - plastic softeners called phthalates
    - vinyl chloride monomer from PVC
34
Q

describe what lot sampling in manufacture involves

A
  • inert container, blank/control
  • avoidances: sifting, carry over, deabsorption, atmospheric addition, volatilisation
35
Q

what are the procedural modes in lot manufacture

A
  1. continuous mode sampling
    - portion
    - continuous flow (liquid/gas) trapping
  2. batch mode sampling
    - Auger, quartering, coning, rifling, sampling thief
    - random
36
Q

what is a major contributor to experimental error

A

sampling

37
Q

what are the 4 most important features limiting analysis

A
  1. cost
  2. time
  3. staff skill base
  4. equipment
38
Q

what are the uses of analysis in cleaning validation

A
  • surface techniques
  • contact, settle
  • swab or rinse
  • air impingers
39
Q

what is used for measurement of analysis in cleaning validation

A

use a modified product assay
- chromatographic- HPLC, LC/MS
- total organic carbon
- UV VIS
-pH
- colony counts, microbial load (DEFT)

PY365 Quality Of Sterile Medicines (19 decks)

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