Quality

controlof

capsule

Supervised By :Dr: SAFIA A.ALREZAMI

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QUALITY CONTRO

L

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Q.C. LABSeparated department which contain specific designWith suitable space ,suitable construction ,good ventilation and separate air supplyAlso 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 ,…

AREA

1- adequate and NO. with practical experience.2-clear responsibilities and no any interpretation.3- high training.4- qualified person with high scientific education.

Q.C. EQUIPMENT

Q.C. EQUIPMENT MUST BE1- VALIDATION 2- CALIBRATION

3-QUALIFICATION 4- S.O.P

5- LOG BOOK

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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 procedures or specifications impacting on the identity, strength, and purity of the drug product.4-mointering in production by I.P.C5-Doing all required tests for arrived material or in production or in finished product or retest of material6-stability study

ROLE

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Q.C TEST

30 capsules are selected and 10 of these are assayed individually.

(1) content uniformity

- At least 9 of these contain 85 – 115 % of drug and none contain below 75- 125% of drug

- If 1 to 3 of them fall outside of 85 – 115% limits–the remaining 20 capsulesare 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.

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- This test applies to all types of capsules and it is to be done on 20 capsules. Limit-Not more than two of the individual weights deviate from the average weight by more than the percentage deviation, and none deviatesby more than twice that percentage.Average Weight of Capsule Content Percentage Deviation Less than 300 mg 10300 mg or more 7.5.

Q.C TEST

(2) WeightUniformity

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The disintegration test determines whether capsulesdisintegrate within a prescribed time when placed in a liquidmedium 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 shouldonly consist of fragments of shell

Q.C TEST

(3) Disintegration

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Q.C TEST

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The dissolution test is carried out using the dissolution apparatusofficial in both the U.S.P. and N.F.

Q.C TEST

What about friability and hardiness and thickiness ?

(4) Dissolution:

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

The finish product

THANK YOU