DMA Document on Expectations for Audits of API Manufacturers

The Danish Medicines Agency (DMA) has published a document entitled: The Danish Medicines Agency's expectations for audits of API manufacturers.

The Qualified Person must make sure that APIs are manufactured in compliance with the requirements laid down in the EU GMP Guide Part 2 (ICH Q7). The task of the qualification of API manufacturers can be delegated to sufficiently qualified staff.

The DMA defined a number of expectations which need to be fulfilled if the QP delegates the task to a third party. The following extracts are taken and shortened from the document

1) Auditors

The following information regarding the Auditors should be available

  • Independence (special caution when using auditors e.g. from traders)
  • Educational background 
  • Training 
  • Experience 
  • Personal qualities

2) Audit Report

An audit should cover all processes relevant to the manufacture and handling of the API concerned. In subsequent audits of an API manufacturer, the focus should be on the other areas than those focused on in the previous audit.

The following information should be part of the Audit report:

  • Products/APIs covered during the Audit (incl. reference to DMF or CEP) 
  • Evaluation of the Product Quality Review
  • Description of cleaning validation (important for multi purpose facilities)
  • Distribution of responsibility between QA and production
  • Correct Classification of deviations identified during the audit. It is recommended to use the classification used in the compilation of procedures (minor, major, critical)
  • An audit conclusion must be unambiguous and decide on the character of deviations

Based on the information provided above, a system-based audit would certainly not comply with the DMA requirements. Therefore, product specific audits are necessary to qualify an API manufacturer.

3) Assessment

In the assessment of an API manufacturer (documented by the QP), the following must be considered:

  • The API manufacturer's follow-up on deviations pointed out in an audit report 
  • Frequency/number of previous audits (and the outcome of those) 
  • Other previous experience from cooperation with the API manufacturer 
  • Any EU GMP certificates and inspection reports from EU authorities issued to the API manufacturer.

It is also important to conclude from data if the API manufacturer found to be GMP compliant.

4) Ongoing Assessment

The Agency also expects that the manufacturer of the medicinal products performs a risk assessment whenever a CEP is withdrawn or a GMP Inspectorates issues a statement of non-compliance.

Source: The Danish Medicines Agency

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