Questions & Answers on Good Distribution Practices (GDP) - Part 4

In October 2020, the ECA offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic.

Below you will find the fourth set of questions which have been answered by the speakers' team. Further Q&As will be published step by step within the next weeks. All answers reflect the opinion of the speakers based on their experience.


Question 4.1: Is the document retention period at least 5 years or can we apply the shelf life plus one year criteria?
Answer: Both are correct. The requirement for GDP is at least 5 years. Manufacturers need to comply with the longest period, so if shelf-life plus 1 year is less than 5 years, then the 5 year requirement applies. Wholesalers must comply with the 5 year retention period, unless holding stock owned by their customer where the customer, for example, requests a longer retention period. Also refer to the requirements of your national legislation and competent authority in the event they require longer than 5 years.

Question 4.2: Regarding documentation, what requirements are there for hand-written documentation?
Answer: Legible, clear, dated and signed.

Questions 4.3: What are requirements for GDP documents in comparison with GMP documents?
Answer: There is no difference! Both need to comply with similar standards, there is alignment of documentation chapters in GMP & GDP.

Question 4.4: Is it okay if we use a seal instead of signatures? The seal will be person specific and controlled.
Answer: No! (There are other opinions on this as well. PIC/S PI 041 states: "The use of personal seals is generally not encouraged; however, where used, seals must be controlled for access. There should be a log which clearly shows traceability between an individual and their personal seal. Use of personal seals must be dated (by the owner), to be deemed acceptable.")

Question 4.5: Regarding electronic signatures, can AdobeSign or DocuSign be used to sign Technical Agreements, which is a GxP-document?
Answer: Any system or programme used to insert electronic or digital signatures needs to be verified and qualified to GxP requirements.
The UK MHRA has written a guide and a useful blog on this.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.