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Pharmacovigilance inspection program: Guidance for medicine sponsors

Version 1.0, September 2017

1 September 2017

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Grading deficiencies

Critical deficiency

A deficiency in pharmacovigilance systems, practices or processes that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines.

Deficiencies classified as critical may include a pattern of deviations classified as major.

A critical deficiency also occurs when a sponsor is observed to have engaged in fraud, misrepresentation or falsification of data.

Major deficiency

A deficiency in pharmacovigilance systems, practices or processes that could potentially adversely affect the rights, safety or well-being of patients or that could potentially pose a risk to public health or that represents a violation of applicable legislation and guidelines.

Deficiencies classified as major may include a pattern of deviations classified as minor.

Minor deficiency

A deficiency in pharmacovigilance systems, practices or processes that would not be expected to adversely affect the rights, safety or well-being of patients.

A deficiency may be minor either because it is judged as minor or because there is insufficient information to classify it as major or critical.

Comment

The observations might lead to suggestions on how to improve quality or reduce the potential for a deviation to occur in the future.

Note:

  • Deficiencies are classified by the assessed risk level and may vary depending on the nature of medicine. In some circumstances an otherwise major deficiency may be categorised as critical.
  • A deficiency reported after a previous inspection and not corrected may be given higher classification.

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