28/29 September 2021
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.