Question { Mylan, 159931 }

what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control

Answer

DEVIATION MEANS - YOU ARE NOT FOLLOWING THE WRITTEN
DOCUMENTED PROCEDURS-MEANS U HAVE ALREADY THE SYSTEM FOR
HANDLING PARTICULAR THING OR EVENT BUT U R NOT FOLLOWING IT
MAY BE PLANNED OR UNPLANNED
BUT IN CASE OF CHANGE CONTROL U R CHANGING THE PROCEDURE
COMPLETLY STATING THAT THE CHANGED PROCEDURE IS THE FINAL
DOCUMENTED PROCEDURE AND ANY VIOLETION FROM IT IS TREATED
AS DEVIATION

Question { Wockhardt, 65323 }

what is the major definition and difference between
uniformity of content and content uniformity as official
test for all tablets?

Answer

uniformity of content(dosage unit):is by two method by
weight variation and by content uniformity.wt variation
means performing assay annd relating with indiviual unit
weight of dosage form.and content uniformity means for ten
sample (dosage unit) individually analysed