FDA Announces Withdrawal of 5 and Revision of 2 Guidances

GMP News No. 746

GMP News
19 June 2006

FDA Announces Withdrawal of 5 and Revision of 2 Guidances

As it announced at the beginning of June, the Food & Drug Administration (FDA) has now withdrawn seven guidances, two of them for revision. The guidances in question had been issued by the "Center for Drug Evaluation and Research" (CDER), the "Center for Biologics Evaluation and Research" (CBER) and by the "Center for Veterinary Medicine" (CVM) or by several of them.

As the reason for the withdrawal, the Agency states that these guidances are inconsistent with the "cGMP for the 21st Century" Initiative. According to the FDA, many of the guidances were created before the new initiative and do not comply with its defined objectives. By means of the initiative, which was introduced in 2002, the FDA intends to promote innovations in the field of production, to concentrate its resources and regulatory attention on the manufacture of medicinal products as well as on the major potential quality risks and to harmonise its regulatory approach.

The list of withdrawn guidances includes some surprises, e.g. BACPAC I by CDER and CBER. Since 2001, this guidance was among the most important documents concerning GMP and Regulatory Compliance in API production. To many, also the withdrawal of the 2 "CMC Draft Guidances" both for APIs and for finished drug products, which had been published as late as 2003 and 2004 respectively, came as a surprise.

The withdrawn guidances include:


  • Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application,
    (February 1987)


  • Submitting Documentation for the Stability of Human Drugs and Biologics(February 1987)
  • Stability Testing of Drug Substances and Drug Products (Draft), (June 1998)
  • Drug Product: Chemistry, Manufacturing, and Controls Information (Draft), (January 2003)
  • Submission of Chemistry, Manufacturing and Controls Information for Synthetic Peptides,
    (November 1994)

The following guidances were withdrawn by CVM for revision (and therefore taken from the CDER and CBER websites):

  • BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Post-approval Changes: Chemistry, Manufacturing, and Controls Documentation(February 2001)
  • Drug Substance: Chemistry, Manufacturing, and Controls Information (draft), (January 2004)

Interestingly, CVM (not CBER and CDER!!) is planning to publish revised versions of both documents. For BACPAC I, this has already been done.

The current developments in API production are the focus of the most important API conference in Europe, which is organised every year by APIC (Active Pharmaceutical Ingredients Committee). More than 20 speakers - among them 2 FDA representatives - will give you first-hand information at the

9th APIC/CEFIC Conference on Active Pharmaceutical Ingredients to be held at the InterContinental Hotel Prague, Czech Republic, from 9-11 October 2006

Details can be found at www.api-conference.org

Compiled by:
Wolfgang Heimes
on behalf of ECA

Source: www.fda.gov/OHRMS/DOCKETS/98fr/85d-0243-nwl0001.pdf

The revised BACPAC I Guideline of CVM can be found here: 

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