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The European Commission publishes the final version of the revised  EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release"

The European Commission has published the final version of the revised EU-GMP Guideline. The guideline specified in Annex 16, under the title "Certification by a Qualified Person and Batch Release" Deadline for coming into operation is 15 April 2016.

The Annex has been revised to reflect the globalization of the pharmaceutical supply chains and the introduction of new quality control strategies. Furthermore, the ICH documents Q8, Q9 and Q10 were implemented. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

The major task of a Qualified Person (QP) is the certification of a batch for its release. In this context, the QP must personally ensure the responsibilities; listed in particular chapter specified (Chapter 1.6) are fulfilled. In chapter 1.7 a lot of additional responsibilities are listed which need to be secured by the QP. The work can be delegated and the QP can rely on the respective Quality Management Systems.

It is important to mention in this context that "the ultimate responsibility for the performance of an authorised medicinal product over its lifetime; its safety, quality and efficacy lies with the marketing authorisation holder (MAH). However "the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force (…), in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).

In that case QP has to rely on the correct functioning of the quality management system of other sites, the QP "should ensure that a written final assessment and approval of third party audit reports has been made". The QP should also "be aware of the outcome of an audit with critical impact on the product quality before certifying the relevant batches."

Another important section clarifies the role of the QP when it comes to deviations, implementing main features of the EMA Position Paper on QP Discretion. Chapter 3 of the draft describes the "handling of unexpected deviations". A batch with an unexpected deviation from details contained within the Marketing Authorisation and/or GMP may be certified if a risk assessment is performed, evaluating a "potential impact of the deviation on quality, safety or efficacy of the batch (es) concerned and conclusion that the impact is negligible." Depending on the outcome of the investigation and the root cause, the submission of a variation to the MA for the continued manufacture of the product might be required.

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