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Separated department which contain specific

design
With suitable space ,suitable construction ,good
ventilation and separate air supply
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Also has separated rooms for
1-large instrument or dangerous ones e.g ,HLPC,
Spectroscopey , IR,radition.
2-Room for micrological and biological tests.
3-room for small instrument e.g pH meter
,viscometer, Dissolution ,friability ,…
1- adequate and NO. with practical experience.
2-clear responsibilities and no any interpretation.
3- high training.
4- qualified person with high scientific education.
1- make the decision of approval or reject of material,
packaging material or finished product.
2- evaluate production record .
3-process of vaildation and cailbration
4-the responsibility for approving or rejecting all
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procedures or specifications impacting on the identity,
strength, and purity of the drug product.
4-mointering in production by I.P.C
5-Doing all required tests for arrived material or in
production or in finished product or retest of material
6-stability study
1
( ) content uniformity
30 capsules are selected and 10 of these are assayed
individually.

least 9 of these contain 85 – 115 % of drug and none

- At

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contain below 75- 125% of drug

- If 1 to 3 of them fall outside of 85 – 115% limits

–the remaining 20 capsules

are individually assayed and the requirements are met if
no few than 27contain 85 – 115 % of drug and none contain
less than 75 – 125 % of drug.
 2
( ) WeightUniformity
- This test applies to all types of capsules and it is to be
done on 20 capsules.
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Limit
-Not more than two of the individual weights deviate
from the average weight by more than the percentage
deviation, and none deviates
by more than twice that percentage.
Average Weight of Capsule Content Percentage
Deviation Less than 300 mg 10
300 mg or more 7.5.
 3
( ) Disintegration
The disintegration test determines whether capsules
disintegrate within a prescribed time when placed in a
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liquid
medium under the prescribed experimental conditions.
-The capsules pass the test if
– No residue remains on the screen of the apparatus or,
– If a residue remains, it consists of fragments of shell or,
– Is a soft mass with no palpable core.
– If the disc is used, any residue remaining on its lower surface should
only consist of fragments of shell
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 4
( ) Dissolution:
The dissolution test is carried out using the dissolution apparatus
official in both the U.S.P. and N.F.

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What about friability and hardiness and thickiness ?

After package quarantine in storage to
Finish check up by Q.C
And after complete the file batch
Send to Q.A
Which send supervisor to check the finish
product and to give order to release
Which Q.C response of release
To marketing……..