USP completes Evaluation of Recall of USP 33

On 9 October 2010, the USP released a public statement on the recall of USP 33-NF 28, according to which the reasons for the recall of USP 33-NF 28 have been investigated and resolved and measures taken to ensure the quality of future volumes of the American Pharmacopeia.

In January 2010, USP 33-NF 28 was recalled after errors were discovered in the publication.

The USP has performed an evaluation of the recall. The reasons leading to this recall include:

  • Lack of appreciation of the project's complexity to redesign all monographs;
  • Inadequate staffing and resourcing. Part of the work was outsourced to consultants with inadequate training;
  • Unrealistic deadlines;
  • Quality Assurance and Quality Control steps usually carried out by the USP were not utilised in this case;
  • USP senior management did not adequately support the project.

On the basis of this understanding, USP has been implementing corrective and preventive action to ensure that future volumes of the U.S. Pharmacopeia are published again in the usual quality.

For further information please see the complete USP statement.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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