The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect.

Among key changes, the guideline increases documentation of the supply chain for active pharmaceutical ingredients and requires drugmakers to have documented evidence ensuring the integrity of imported batches.

At third-country manufacturing sites, sampling should include a quality risk management plan, as well as an audit of the manufacturing and sampling activity at the third-country site.

QPs also need to describe the sampling process in the third country and the transported conditions of the sample and the imported batch, justifying any differences. A comparative analysis of samples taken in the third country and samples taken after importation also needs to be performed, taking into account the time difference between sampling and importation.

The guideline incorporates recommendations of three ICH standards: Q8 on pharmaceutical development, Q9 on quality risk management and Q10 on pharmaceutical quality systems.

The guideline — Annex 16: Certification by a Qualified Person and Batch Release — also details tasks that can be delegated to trained staff or third parties, such as ensuring that audits of manufacturing sites have been conducted and that appropriate arrangements for distribution and shipment are in place.

Robert Schiff, president and CEO of Schiff and Company, notes that for drugs to be released in the EU, the QP must be based there. That has implications for foreign multinationals, he says, noting an Indian drugmaker would need to have an EU-based QP to sell its product on the continent.

The guideline, which revises a July 2001 version, takes effect next April.

Get the last word on current regulations, guidelines, and auditing standards for APIs in our book Drugmakers’ Guide to Global Quality API Manufacturing. You’ll discover clear plain-English explanations of dozens of pressing manufacturing quality issues, including how regulators in various countries define APIs, how to prepare for and conduct audits of API suppliers and much more.