【讨论】European Commission publishes Question & Answer Document on GDP

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On 28 March 2014 the European Commission has published a new question and answers document which will clarify some frequent asked questions about the interpretation of the new EU GDP Guideline.
The document contains 25 questions and answers. Some of the questions are simply for clarification and confirmation. However, some other questions have become the basis for some discussion. The competent authorities of the different EU Member States should use a harmonised approach when it comes to inspections.
Question 5 for example refers to the requirement 3.2 about the physical segregation of certain products. According to the document, falsified, expired, recalled and rejected products need a physical segregation in any case. So a validated computerized system would not be possible in these cases.
Question 7 refers to chapter 3.2.1. about the number of probes which are necessary to monitor the temperature. The EU commission clarifies that "the number of probes and their placement depend on the risk analysis performed on the site and the placement should be in agreement with the mapping results".
Also question 8 highlights the importance of a risk analysis. In this question the topic of initial temperature mapping is covered. The document states that "initial temperature mapping is an exercise in which temperature sensors are placed on the points identified as most critical through a risk analysis (e.g. at different heights, near a sunny window, next to the doors, etc.). Once placed, a measurement is taken over a period of time and with the results obtained, the temperature sensors will be places where greater fluctuation occurred. The mapping should be performed in different seasons where highest and lowest temperatures are reached."
In question 22 reference was made to chapter 9 of the GDP Guide. Some stakeholders proposed to have a limited time frame (e.g. of 6 hours) in which a deviation of a defined temperature range (e.g. 2-25 C) would be allowed. But the EU Commission clearly states that this procedure would not be acceptable.
Source: EU Commission, Good Distribution Practice, Question and Answers, Version 1.0

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