Friday, 20 June 2014
Tuesday, 10 June 2014
Thursday, 5 June 2014
Sunday, 1 June 2014
Wednesday, 28 May 2014
Saturday, 24 May 2014
Frequently asked questions in Pharmaceutical QA Interview
Q. Brazil
falls under which climatic zone ?
Q. According
to WHO guidelines what is the storage condition of climatic zone IVa and
zone IVb?
Q. What is
dead leg?
Q. Brief about ICH stabilty guidelines?
Q. What is significant changes in stability testing?
Q. Why do
we check hardness during inprocess checks?
Q. Which
type of tablets are exempted from Disintegration testing?
Q. What needs to be checked during inprocess QA checks?
Q. In a tablet manufacturing facility ‘positive’ pressure is
maintained in processing area or service corridors?
Q. If sticking observed during tablet compression what may the
probable reason for the same?
Q. Why do we consider three consecutive runs/batches for process
validation? Why not two or four?
Q. Why do we calibrate a qualified equipment/instrument on definite
intervals?
Q. What needs to be checked during AHU validation?
Q. What is the difference between calibration and Validation?
Friday, 23 May 2014
OOS ( Investigating Out-of-Specification )
Guidance for Industry
Investigating Out-of-Specification (OOS)
Test Results for Pharmaceutical Production
I. INTRODUCTION
This guidance for industry provides
the Agency’s current thinking on how to evaluate out-of-specification (OOS)
test results. For purposes of this document, the term OOS results includes all test
results that fall outside the specifications or acceptance criteria established
in drug applications, drug master files (DMFs), official compendia, or by the
manufacturer. The term also applies to all in-process laboratory tests that are
outside of established specifications.
This guidance applies to
chemistry-based laboratory testing of drugs regulated by CDER. It is
directed toward traditional drug
testing and release methods. These laboratory tests are
performed on active pharmaceutical
ingredients, excipients and other components, in-process materials, and
finished drug products
to the extent that current good
manufacturing practice(CGMP) regulations (21 CFR parts 210 and 211)and the
Federal Food, Drug, and Cosmetic Act
(the Act) (section 501(a)(2)(B))
apply. The principles in this guidance also apply to in-housetesting of drug
product components that are purchased by a firm.
This guidance can also be usedby
contract firms performing production and/or laboratory testing responsibilities.Specifically,
the guidance discusses how to
investigate OOS test results, including the responsibilities of
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