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 be scientifically justified and include a quality risk-management process. The process should include an audit of the manufacturing and sampling activity at the third-country site and evaluate the transportation steps for both the finished batch and samples to ensure the samples are representative of the imported batch.
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 of the batch, the guideline says.
QPs should also periodically analyze samples taken after importation to justify ongoing reliance on third-country samples and perform comprehensive reviews of any unexpected results or confirmed out-of-specification results.
The guideline also incorporates the recommendations of three International Conference on Harmonisation 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. Read it at www.fdanews.com/10-15-15-Annex16.pdf. — Kellen Owings