Rx-360 Summary of the EU GDP Questions and Answers

Rx-360 has provided the following summary of the EU GDP Questions and Answers:

On 28 March 2014 the European Commission published a question and answers document related to the new guideline on Good Distribution Practice of medicinal products for human use applicable as of November 2013.

The Q&A document contains 25 questions and answers. The questions focused mainly around

• Competence and training of personnel (chapter 2)

• Segregation of products, temperature and environmental control, alarms and deviations (chapter 3)

• Qualification of customer, verification of authorization for sale (chapter 5)

• Control of returned products and recall procedure (chapter 6)

• Transport requirements (temperature, safety) (chapter 9).
 

Some of the questions are simply for clarification and confirmation. Other questions may have become the basis for some discussion:

• Question 5 (chapter 3.2(3)): It was confirmed that falsified, expired, recalled and rejected products need a physical segregation in any case. A validated computerized system (electronic segregation) cannot substitute in these cases.

• Questions 7 & 8 refer to chapter 3.2.1. about temperature and environment control. The EU commission highlights the importance of risk assessments as basis for the design of temperature mapping studies and the positioning of monitoring sensors. Further clarification on the design of mapping studies was given (e.g. studies to be performed in different seasons).

• Questions 13 & 14 are related to product authorization for sale (chapter 5.4.(3)). Different requirements are applicable dependent on the origin of the product (EU member state or not). But in any case the wholesalers need to verify that a batch of medicinal products is authorized for sale in the target state (provision applicable today independent of potential future implementation of safety features allowing traceability through a database).
Question 22 (chapter 9.2.(1)): Some stakeholders proposed to allow transport conditions which may deviate from the standard storage conditions, e.g. greater temperature range for a limited time frame. The EU Commission clearly states that this procedure would not be acceptable.
  
To view or download the EU GDP Document, click here