Rx-360 Summary of the EU GDP Questions and Answers
![](/46/pdcnewsitem/03/32/52/nV8ZbWIg70yMAKN.png)
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
Related News
-
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance