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
Crystal chemistry book PDF
Physical Methods in Inorganic Chemistry
First Half: Crystallography
Textbooks
W. Massa/R. Gould: Crystal Structure Determination (Springer)
•
C. Giacovazzo(Ed.): Fundamentals of Crystallography
(Oxford University Press)
•
L. Bragg (Ed.): The Crystalline State (4 volumes)(Cornell University Press)
•
Kleber/Bausch / Bohm: Einführungin die Kristallographie
(VerlagTec)
ANALYTICAL INSTRUMENT QUALIFICATION as per USP Gen Chapter
1058
ANALYTICAL INSTRUMENT QUALIFICATION
INTRODUCTION
A
large variety of laboratory equipment, instruments, and computerized
analytical systems, ranging from simple nitrogen evaporators to complex
multiple-function technologies (see Instrument Categories),
are used in the pharmaceutical industry to acquire data to help ensure
that products are suitable for their intended use. An analyst's
objective is to consistently obtain reliable and valid data suitable for
the intended purpose. Depending on the applications, users validate
their procedures, calibrate their instruments, and perform additional
instrument checks, such as system suitability tests and analysis of
in-process quality control check samples to help ensure that the
acquired data are reliable. With the increasing sophistication and
automation of analytical instruments, an increasing demand has been
placed on users to qualify their instruments.
Unlike
method validation and system suitability activities, analytical
instrument qualification (AIQ) currently has no specific guidance or
procedures. Competing opinions exist regarding instrument qualification
and validation procedures and the roles and responsibilities of those
who perform them. Consequently, various approaches have been used for
instrument qualification, approaches that require varying amounts of
resources and generate widely differing amounts of documentation. This
chapter provides a scientific approach to AIQ and considers AIQ as one
of the major components required for generating reliable and consistent
data. Note that the amount of rigor applied to the qualification process
will depend on the complexity and intended use of the instrumentation.
This approach emphasizes AIQ's place in the overall process of obtaining
reliable data from analytical instruments.
Wednesday, 21 May 2014
Principle of Reversed-Phase Chromatography with animation
Principle of Reversed-Phase Chromatography with animation
Reversed-phase chromatography is all about the particle surface of the HPLC/UPLC column and the eluent solvent. The first slide shows a diagramatic view of the column with many small silica particles
Click here for principle-of-reversed-phase-chromatography-hplcuplc-with-animation/
Reversed-phase chromatography is all about the particle surface of the HPLC/UPLC column and the eluent solvent. The first slide shows a diagramatic view of the column with many small silica particles
Click here for principle-of-reversed-phase-chromatography-hplcuplc-with-animation/
Monday, 19 May 2014
SOPs FOR ALL DEPARTMENTS
This link is one of the best to create a SOP for any department like production, QC, QA etc.Its providing most information regarding content and template and arrangement of SOP.
Follow this link when you creating new SOP
CLICK HERE
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