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MPharm Semester 2 > Legal Pharmacy > Flashcards

Legal Pharmacy Flashcards

1
Q

What are five ways in which the quality of medicines are controlled?

A 
Overall Design- Quality Assurance (QA)
Procedures- Good Manufacturing Practice (GMP)
Testing- Quality Control (QC)
Documentation
Training
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2
Q

If a medicine contains water, what else is it likely to contain?

A

A preservative, unless its single use

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3
Q

What is Quality Assurance (QA)?

A

It is the sum total of the organised arrangements made with the object of ensuring the medicinal products are of the quality required for their intended use

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4
Q

What is Good Manufacturing Process (GMP)?

A

Is a list of standards that you need to comply to
Shows the minimum standards medicines manufacturer must meed in their production process
Is part of the QA
Documentation needs to be written down

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5
Q

What is Quality Control (QC)?

A

Part of the GMP
Concerned with sampling, specifications and testing
Comparisons against specifications
Mainly testing of raw materials and finished products

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6
Q

What are the two types of specifications in a factory and what do they include?

A

Raw material specification
- describes the necessary chemical and physical properties of a raw material
- gives the reference number of necessary tests
• Finished product specification
- describes the necessary chemical and physical properties of a finished product
- gives the reference number of necessary tests

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7
Q

Name the seven types of records for documentation:

A
  1. Analytical test record
  2. Cleaning record
  3. Training record
  4. Use and maintenance record
  5. Receipt record
  6. Dispatch record
  7. Reconciliation record
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8
Q

What is an analytical test record?

A

Describes in detail the results of all tests on a product
- gives the reference number of the tests used
- states who did the work
- states whether the batch complies with the relevant
specification

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9
Q

What is a cleaning record?

A

Records that equipment has been cleaned before being used

  • states who did the cleaning
  • states who approved that the cleaning was done and that the equipment was fit for use
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10
Q

What is a training record?

A

Records that staff have been trained in a particular procedure

  • states who did the training
  • states the “level of achievement” of the trained individual
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11
Q

What is a use and maintenance record?

A

Records the use of a particular piece of equipment

  • states who used it
  • states the product it was used for
  • states any maintenance or repair of the equipment
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12
Q

What are batch manufacturing documents?

A

A unique summary of how each batch was manufactured and packaged, part SOP and part record

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13
Q

What is a specification and how would something pass this?

A

A statement about an attribute with which the product must comply to be approved for use. Each attribute will have a separate specification. To pass it would need to pass ALL specification tests

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14
Q

Name all nine specifications of a tablet and state whether they are unofficial or official:

A

1) Weight uniformity (mass uniformity) OFFICIAL
2) Content (Composite Assay) UNOFFICIAL
3) Content uniformity (individual) OFFICIAL
4) Disintegration time OFFICIAL
5) Dissolution profile OFFICIAL
6) Hardness UNOFFICIAL
7) Friability OFFICIAL
8) Thickness UNOFFICIAL
9) Loss on Drying (LOD) (UNOFFICIAL but OFFICIAL for some specific drugs

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15
Q

Describe the tablet specification for weight uniformity:

A
  • Weigh individually 20 tablets from the same batch
  • Calculate mean weight
  • Batch passes if it complies with the following specification:
    Not more than 2 tablets deviate from the mean weight by more than the allowable limit and none by more than twice the limit
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16
Q

Describe the tablet specification for content:

A

To ensure that the average drug content of the tablets in a batch is as stated
- Assay 10 tablets from the same batch as a “composite”
- calculate average content
- batch passes if the result is within 90 to 110 % of stated value
• During development, use a specification of 95 to 105 % of stated

17
Q

Describe the tablet specification for content uniformity individual:

A

To ensure that all individual tablets of a batch contain the stated amount of drug
Method (stage 1)
- assay (test) individually 10 tablets from the same batch
- calculate mean drug content
- batch passes if all tablets are within 85 and 115 % of the mean - batch fails if more than one tablet is outside these limits
- batch fails if one tablet is outside 75 to 125 % of the mean
Method (stage 2)
- if one tablet from stage 1 was outside 85 to 115 % of the mean but within 75 to 125 % of the mean
- assay (test) individually 20 more tablets from the same batch
- calculate mean drug content of the 30 tablets
- batch passes if not more than one tablet is outside 85 to 115 %
of the mean and none is outside 75 to 125 % of the mean

18
Q

Describe the tablet specification for disintegration time:

A

Specifications:
uncoated tablets 15 minutes, coated tablets 30 minutes, effervescent tablets 5 minutes, soluble tablets 3 minutes
• Most immediate-release tablets disintegrate in 5 minutes
• Enteric-coated tablets must remain intact in 0.1 M HCl for 2 hours and disintegrate in phosphate buffer pH 6.8 within 1 hour

19
Q

Describe the tablet specifications for dissolution profile:

A

Test conditions reflect the stomach conditions: 0.1 M HCl

Immediate-release tablets, “standard” is 80 % dissolved within 15 minutes

20
Q

Describe the tablet specification for friability:

A

To ensure that the tablet can withstand handling
Method:
- weigh 20 tablets (up to 650 mg) or 10 tablets (> 650 mg) - place tablets in a drum and rotate for 100 revolutions
- weigh tablets and calculate weight loss
• BP specification = 1 % weight loss - this is very high!!!!!
• In development, use 0.2 % weight loss as the limit

21
Q

Name all four specifications of a capsule and state whether they are unofficial or official:

A

1) Weight uniformity (mass uniformity) (OFFICIAL)
2) Content (Composite Assay) (UNOFFICIAL)
3) Content uniformity (OFFICIAL)
4) Disintegration time (OFFICIAL)

22
Q

Describe the capsule specification for weight uniformity:

A

Method
- weigh an intact capsule
- empty contents completely (without losing any part of the shell)
[NOTE: For soft shell capsules, wash the shell with a suitable solvent and allow to stand until the odour of the solvent is no longer perceptible.]
- re-weigh the shell
- calculate weight of contents by difference
- repeat 19 times
- calculate mean weight
- batch passes if it complies with the following specification:
the contents of not more than 2 capsules deviate from the mean weight by more than the allowable limit and none by more than twice the limit

23
Q

Describe the capsule specification for content:

A

To ensure that the average drug content of the tablets in a batch is as stated
- Assay 10 tablets from the same batch as a “composite”
- calculate average content
- batch passes if the result is within 90 to 110 % of stated value
• During development, use a specification of 95 to 105 % of stated

24
Q

Describe the capsule specification for content uniformity:

A

Method (stage 1)
- assay (test) individually 10 capsules from the same batch
- calculate mean drug content
- batch passes if not more than one individual capsule is outside
85 to 115 % of mean and none is outside 75 to 125 % of mean
- batch fails if more than three individual capsules are outside 85 to 115 % of mean or if one or more capsules are outside 75 to 125 % of mean
Method (stage 2)
- if two or three capsules from stage 1 were outside 85 to 115 % of the mean but within 75 to 125 % of the mean
- assay (test) individually 20 more capsules from the same batch
- calculate mean drug content of the 30 capsules
- batch passes if not more than three capsules are outside 85 to 115 % of the mean and none is outside 75 to 125 % of the mean

25
Q

Describe the capsule specification for disintegration time:

A

Specifications:
30 minutes
- shells take about 3 to 5 minutes to disintegrate
- most fills disintegrate by 10 minutes
- Enteric-coated capsules must remain intact in 0.1 M HCl for 2 hours and disintegrate in phosphate buffer pH 6.8 within 1 hour

MPharm Semester 2 (9 decks)

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