EMA Updates Inspector Expectations for API Audits

By Zachary Brennan

- Last updated on GMT

EMA Updates Inspector Expectations for API Audits

Related tags Audit

As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.

As part of their assessment of a manufacturing authorisation holder’s (MAH) systems for confirming GMP (good manufacturing practice) compliance, inspectors will expect to see “full details of these [audit] reports upon request, including responses received from the audited site, indication of closure of deficiencies raised and/or commitments made​,” the EMA said in an update to its Q&A on GMP​.

The scope of such audit reports should include a minimum of information on high risk areas and focus on:

  • Process, cleaning and validation;
  • Risk of cross contamination with other active substances or other substances;
  • Potential for unknown impurities;
  • Risk of confusing materials and products through handling and packing materials;
  • Change control;
  • Deviation recording and management; and
  • Security sealing of API containers and security or temperature control of shipments.

In addition to ensuring the validity and impartiality of the audit report when it’s conducted by a third party, the report also must contain background information on the API manufacturer, the length of the audit and information on “key staff​” participating in the audit.

Auditor Qualification

The EMA also updated how auditors should have sufficient scientific and technical experience to ensure their audits of active substance manufacturers are “adequate and thorough​.” 

Auditors must be trained and assessed in their knowledge of EU GMP Part II and in auditing techniques in general, with full documentation of such training and experience. 

Where a proposed auditor lacks an appropriate level of direct experience in the field of active substance manufacture, he or she should undergo a documented training and assessment program in the areas that are relevant to the audit, taking into account the auditor’s anticipated role in the audit and the technologies that are likely to be encountered during the audit​,” the EMA says. 

Upcoming Deadlines​ 

The updated Q&A on active substance audit reports comes as the European Commission prepares to take action on its July 2 deadline for API (active pharmaceutical ingredient) imports. Such importers must obtain written confirmation that they adhere to EU GMP standards.

Last month, the Commission said that China and India​ have more work to do in order to meet that deadline.

Since then, India’s CDSCO (Central Drugs Standards Control Organization) revealed that it only provided written confirmation to Teva for API exports to the EU, according to the regulator’s website. The written confirmation is valid for three years.

A few days prior to CDSCO, China’s CFDA (China Food and Drug Administration) said​ that it recently issued a notice specifying the scope of what companies can apply to have their active substances exported to the EU.

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