In January this year, the FDA published a draft guidance on "ANDAs:
Impurities in Drug Substances". At this stage, the industry can and
should hand in comments, as described on the first page of the document.
The guideline explains which specifications on the contamination
profile of chemically synthesized raw materials have to be made if, for a generic
an application of approval (abbreviated new drug application) or
supplements on this due to a change in the process
or synthesis or
a drug master file
is handed in.
The guideline also includes recommendations on the definition of
acceptance criteria for impurities in raw materials.
After its finalisation, this guideline is
meant to replace the document of the same name that was published in 1999.
The crucial reasons
for the revision were:
- the specifications for the listing of impurities and the
establishing of corresponding acceptance criteria had to be updated;
- the guideline "Q3A Impurities
in New Drug Substances (Q3A)(R)" published in February 2003 had to be taken into consideration.
So the guideline of 1999 includes several chapters
that are also part of Q3A(R), e.g. "Classification of Impurities",
"Rationale for the Reporting and Control of Impurities",
"Analytical Procedures". Through the revision of the
guideline these redundancies are eliminated.
You can read the new draft guidance if you
The important topic "qualification
of impurities and definition of acceptance criteria" is one of the focal
points of the GMP Education Course Impurities,
which is organised by the European Compliance Academy in co-operation with
CONCEPT HEIDELBERG in Prague on 10-11 May 2005.
to read the detailed programme.
Dr Gerhard Becker