Danish Medicines Agency - Questions and Answers on GMP for APIs

The Danish Medicines Agency (DMA) offers a list of questions and answers dealing with the GMP requirements on active pharmaceutical ingredients (APIs).

This collection of questions and answers is not new, but maybe of interest to colleagues involved in this field. The first Q and A highlights that future inspections of medicinal product manufacturers will also focus on the audit reports, which must be available for each API manufacturer.  The second Q and A stresses that the DMA will accept Third-Party Audit reports. The Agency again emphasises the requirements laid down by EMEA. One key issue here is the independence of the auditor from the company to be audited. An important issue, which was also highlighted by the API Compliance Institute just recently.

Which documentation is required to substantiate that the active substance has been manufactured in accordance with GMP?

Answer: The pharmaceutical manufacturer must have audit reports on all its API manufacturers (in respect of manufacturing, packaging, repackaging, mixing, labelling, relabelling and supplementary labelling). Audit reports will become an issue for future inspections at the premises of pharmaceutical manufacturers.

What measures does the Danish Medicines Agency accept in respect of audit of API manufacturers?

Answer: The Danish Medicines Agency accepts third-party audit reports. However, in connection with all audit reports the following must be documented:

  • " That the auditor is qualified to audit.
  • " That the auditor is independent of the company to be audited.
  • " That the auditor is acquainted with the Rules Governing Medicinal Products in the European Union, Volume 4, Part II.
  • " That the audit report has been reviewed by the pharmaceutical manufacturer.
  • " That the audit report is adequate. In connection with third-party audit reports, summaries are not accepted.

Source: DMA Website

What is your experience with other EU agencies? You can follow up on these topics. Please submit your comments in our discussion forum.

Will the EU inspectors request a closer look into the audit reports? With regard to internal audits, this has never been requested; but this may change. Are there any experiences yet? Here you can enter your comments.

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