The new Annex 16 is coming into Force
The new Annex 16 “Certification by a Qualified Person and Batch Release” will become effective as of 15 April 2016. The contents will reflect the coming state of expectations regarding the batch release.
The new Annex 16 “Certification by a Qualified Person and Batch Release” will become effective as of 15 April 2016.
It is centrally pointed out that the main duty of a Qualified Person (QP) is the certification of batches. In this context, the QP must personally ensure that the responsibilities listed under Chapter 1.6 are fulfilled. Chapter 1.7 lists many other responsibilities to be guaranteed by the QP. However the related activities can be delegated and the QP can rely on the respective quality management systems. Yet, the “QP should have on-going assurance that this reliance is well founded” (1.7). The 21 responsibilites listed include amongst others:
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