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Extemp > QC/QA/GMP/PMS/QMS > Flashcards

QC/QA/GMP/PMS/QMS Flashcards

1
Q

How does QA relate to GMP and QC?

A

QA encompasses GMP which encompasses QC.

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2
Q

What do quality assurance systems ensure?

A

Quality. Products are designed and developed according to GMP.

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3
Q

What is the Orange Guide definition of QC?

A
  • concerned with sampling, specifications and testing, and organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out and that materials are not released for use until their quality has been judged to be satisfactory.
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4
Q

What are the main requirements of Quality Control? [6]

A
  1. Adequate facilities, trained personnel and approved procedures.
  2. Samples of all steps in process tested and retained.
  3. Validated test methods.
  4. Records of sampling and any deviations made.
  5. Testing should include product in final container with label applied.
  6. Complaints handling process must exist.
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5
Q

What does ‘Fit for intended purpose’ mean? [8]

A
  1. Sterile
  2. particle free - unless suspension.
  3. Contamination free.
  4. For right patient.
  5. Containing correct drug at correct dose, concentration and frequency.
  6. Labelled correctly.
  7. Appropriate shelf-life.
  8. Appropriate administration device.
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6
Q

What are the recommended microbial contamination limits for a Grade A room?

A

Air Sample:

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7
Q

What are the recommended microbial contamination limits for a Grade B room?

A

Air Sample: 10
Settle plate (4hrs): 5
Contact plate: 5
Glove: 5

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8
Q

What are the recommended microbial contamination limits for a Grade C room?

A

Air Sample: 100
Settle plate (4hrs): 50
Contact plate: 25
Glove: N/A

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9
Q

What are the recommended microbial contamination limits for a Grade D room?

A

Air Sample: 100
Settle plate (4hrs): 100
Contact plate: 50
Glove: N/A

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10
Q

How is it possible to measure the quality of the air in a room? [2]

A
  1. RCS High flow device which takes a known volume of air and uses impaction or centrifugal forces but causes physical stress to the bacteria which may cause lower than actual reading.
  2. Settle plate. Passive technique where-by bacteria settle out via gravity. Simple to measure and causes no physical damage to the bacteria. But only represents
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11
Q

What are the drawbacks to the different methods of monitoring the air quality in a room?

A
  1. RCS High flow device which takes a known volume of air and uses impaction or centrifugal forces but causes physical stress to the bacteria which may cause lower than actual reading.
  2. Settle plate. Passive technique where-by bacteria settle out via gravity. Simple to measure and causes no physical damage to the bacteria. But only represents
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12
Q

How is it possible to monitor the microbiological bioburden of the working surface in a lab?

A

Contact plates are used or a contact swab.
Surface should be washed down after contact to remove any agar residues from work surface. Agar must contain a neutraliser to prevent any disinfectant present on bench from transfering across and preventing growth.

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13
Q

Why must a neutraliser be included in the plates used in contact testing?

A

Surface should be washed down after contact to remove any agar residues from work surface. Agar must contain a neutraliser to prevent any disinfectant present on bench from transfering across and preventing growth.

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14
Q

Is sterility testing used for aseptic products?

A

No. Takes 14 days, too long may even be longer than shelf-life of product prepared. Only tests the one container sampled not useful if only 5 were prepared.

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15
Q

How are aseptic products tested for sterility?

A

Broth is pumped through any equipment used in their preparation and grown overnight to assess for any contamination.

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16
Q

Why do we measure the degree of particle free-ness of a room?

A

It can provide an early indication of potential microbial contamination. HEPA filters, Bubble point filter tests. Continuous particle monitoring.

17
Q

What are the particle limits of a Grade A room at rest?

A
  1. 5: 3,520

5. 0: 20

18
Q

What are the particle limits of a Grade A room in operation?

A
  1. 5: 3,520

5. 0: 20

19
Q

What are the particle limits of a Grade B room at rest?

A
  1. 5: 3,520

5. 0: 29

20
Q

What are the particle limits of a Grade B room in operation?

A
  1. 5: 352,000

5. 0: 2,900

21
Q

What are the particle limits of a Grade C room at rest?

A
  1. 5: 352,000

5. 0: 2,900

22
Q

What are the particle limits of a Grade C room in operation?

A
  1. 5: 3,500,000

5. 0: 29,000

23
Q

What are the particle limits of a Grade D room at rest?

A
  1. 5: 3,520,000

5. 0: 29,000

24
Q

What are the particle limits of a Grade D room in operation?

A

N/A

25
Q

How do we test the contents of aseptic products? [3]

A
  1. Flame photometry for ion content
  2. UV absorption for ID of drug content.
  3. End process testing such as HPLC or atomic absorption.
26
Q

What are the main quality issues that arise when using needles/syringes? [3]

A
  1. Droplets between seals occurring: after preparation, during transport, during storage.
  2. Gross failure of seals.
  3. Dead space + double dead space.
27
Q

What risk do air bubbles in parenteral products pose?

A

Air embolism, incorrect volume + therefore concentration/dose of drug.
Implications for stability and infusion rate.

28
Q

What risks do an incorrect bung seal on a syringe pose?

A
  1. Reduced safety barrier.
  2. Integrity of syringe is compromised.
  3. Risk of contamination to patient.
29
Q

How can Quality Assurance ensure that products are contamination free? [7]

A
  1. Use of licensed starting materials.
  2. CE marked devices and components.
  3. Appropriate segregation of products and/or facilities.
  4. Appropriate diluent(s)
  5. Appropriate shelf-lifes and stability testing.
  6. Validated cleaning procedures.
  7. Demonstration that cross-contamination is not occurring.

Extemp (12 decks)

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