L134- Specification Flashcards
what is quality assurance?
wide ranging concept which covers all matters which collectively or individually influence the quality of a product. 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.”
what are the documents for specification?
raw materials spec- describes the necessary chemical and physical properties of a raw material
finished product spec- describes the necessary chemical and physical
properties of a raw material
what must a specification be like?
- clear and unambiguous
- reviewed regularly
- approved by an appropriate person
what is a specification?
is a statement about an attribute with which the product must comply to be approved for use. Each attribute will have a separate specification.
what needs to happen for a batch of pharmaceutical products to pass?
the batch needs to pass ALL specification tests.
what are non-pharmacopoeial specifications?
specification thats are specific to individual product
what are the different types of tablet specifications?
1) weight uniformity -official
2) Content -unofficial
3) Content uniformity -official
4) Disintegration time- official
5) Dissolution profile -official
6) Hardness- unofficial
7) Friability -official
8) Thickness- unofficial
9) Loss of drying -unofficial/official
what is the weight uniformity specification?
- it ensures that all tablets contain the same amount of drug
- ensure that the patient gets a reproducible dose of the drug
what is the method for weight uniformity?
- weigh individually 20 tablets from the same batch
- calculate mean weight
- batch passes if it complies with the following specification:
1) no more than 2 tablets deviate from the mean by <80mg is 10%, 8-250mg is 7.5%, >250mg is 5%
what is the content spec?
• To ensure that the average drug content of the tablets in a batch
is as stated (within limits)
to ensure that the patient gets a reproducible dose of drug
• Used for activities such as stability studies
what is the method for content spec?
- 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
what is the content uniformity spec?
• Applies to all tablets eg uncoated, coated, effervescent, chewable
• To ensure that all individual tablets of a batch contain the stated
amount of drug (within limits)
to ensure that the patient gets a reproducible dose of drug
what is the method of the content uniformity spec?
- step one
-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
step two - 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
what is the disintegration time spec?
• Applies to all tablets eg uncoated, coated, effervescent, chewable
• To ensure that all tablets disintegrate within a specific time
to ensure that the biological effect is reproducible
• Test equipment and conditions specified in BP (water, 37°C)
what is the specification for disintegration time?
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
