Finally published: new Annex 16 on QP Certification and Batch Release

New Drug Approvals

Finally published: new Annex 16 on QP Certification and Batch Release

The European Commission finally has published the new 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 Annex 16 “Certification by a Qualified Person and Batch Release”. Deadline for coming into operation is 15 April 2016.

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 responsibilities listed in 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. However “the QP should have on-going assurance that…

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