FDA Publishes a New Draft Guideline on Impurities in Raw Materials

GMP News No. 539

GMP News
12 April 2005

 FDA Publishes a New Draft Guideline
on Impurities in Raw Materials

In January this year, the FDA published a draft guidance on "ANDAs: Impurities in Drug Substances".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 drug, 

  • 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You can read the new draft guidance if you click here.

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.

Click here to read the detailed programme.

Dr Gerhard Becker
Project Manager

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