EMA, WHO Update Key GMP Guidelines

European regulators want to revise good manufacturing practice (GMP) guidelines to clarify how quality personnel oversee batches manufactured at remote sites. And the World Health Organization (WHO) is also updating its GMPs to reflect industry trends.

The European Medicines Agency (EMA) recently released a draft revision to Annex 16 of the GMP guidelines, bringing it up to date with current trends in the drug industry.

The annex, introduced in 2002, provides guidance on how a qualified person (QP) can certify a batch release. The QP can delegate some of the tasks required to certify a batch is safe and rely on the quality management system. However, the QP must ensure that this “reliance is well founded,” the guideline reads.

The EMA emphasizes that the QP is still responsible for ensuring that a particular batch was manufactured in accordance with EU GMPs.

Petra Rybackova, EMA scientific administrator for manufacturing and quality compliance, said the revision also brings the annex in line with the International Conference on Harmonisation’s Q8, Q9 and Q10 quality system guidelines.

The update also clarifies what documentation is needed to accompany batches that move between EU member states, she added.

Meanwhile, the WHO recently updated a guideline for quality risk management (QRM) also intended to address current trends. The update contains advice for global regulators and drugmakers on how to install QRM principles.

The guideline describes QRM principles as:

• The evaluation of the risk to quality based on science and patient protection; and
• The process of documenting QRM practices commensurate with the level of risk.

The WHO said that QRM principles can help regulators allocate inspection resources. They can also help manufacturers install a corporate culture of quality, the WHO said.

Drugmakers have been stepping up such efforts. Ranbaxy, like many of its peers, recently trumpeted a list of quality “enhancements” it is making that closely track recommendations FDA officials persistently promote to prevent problems. The Indian company, among other things, is encouraging its workers to communicate quality issues with upper management as well as through a new whistleblower program.

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