EU-GMP: New Annex 16 released

The European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release".

As one important topic, it has been pointed out that 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 tasks listed chapter 3.5., and, for certain products, those listed in chapter 3.6 and 3.7. A lot of these tasks can be delegated and the QP can rely on the respective Quality Management Systems. However "the QP should have on-going assurance that this reliance is well founded" (3.5.3). Amongst these tasks are for example:

  • Starting material compliance and supply chain security, including GMP assessments by third parties
  • Manufacturing and testing performance
  • Manufacturing and testing processes validation
  • Changes and investigations completion

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). "(2.1.). "… the responsibility for ensuring that a particular batch has been manufactured in accordance with its marketing authorisation, with EU Good Manufacturing Practice (GMP), or equivalent, … lies with the QP"(2.2).

In the case that the 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 (which was issued in February 2006 and updated January 2008). Chapter 5 of the draft describes the "handling of unplanned deviations". A batch with an unplanned/unexpected deviation from details contained within the Marketing Authorisation and/or GMP may be certified if a risk assessment clearly indicates that the deviation has no "adverse  effect on quality, safety or efficacy of the product" (as long as the registered specifications for active substances, excipients and finished products have been met).

Stakeholders are invited to comment on this draft (150 KB) by 5 November 2013 at the latest. Comments should be sent by email to: and The deadline for coming into operation is 6 months from publication.

In a special session at the 8th QP Forum from 28-29 November 2013 in Lisbon, Portugal, you will also be able to discuss this draft.

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