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Cover of the Good Distribution Practice for Active Substances Guidance
Cover if the GDP Guidance on Interpretation and Implementation


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09/03/2021
 

Questions & Answers on Good Distribution Practices (GDP) - Part 2

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

The Role of the Responsible Person for GDP

Question 2.1: Can the Responsible Person (RP) delegate all type of tasks? What about even more critical tasks such as release of product etc.?
Answer: Provided the RP ensures that all delegated tasks are properly documented and described in a formal procedure and the person performing the task has been appropriately trained he/she can delegate the performance of the task. However, the responsibility for that task remains with the RP.

Question 2.2: What legally-binding documents would the RP need to sign related to the products, besides Quality Agreements?
Answer: Apart from quality related document, no other requirement, but a company may choose to have their RP to sign of various documents.

Question 2.3: What is the impact of Brexit on RP requirements?
Answer: In UK, companies importing products from approved countries need to have a Responsible Person (import) (RPi), otherwise there is no change to the role of RP in EU.

Question 2.4: Can QMR be RP or separate person to be appointed? Also company is doing warehousing and distribution and it has multiple sites (e.g. 14 warehouse in the country in different location), does it require to have RP for all sites?
Answer: RP is a specific role for WDA holders. QMR is a defined role for companies handling APIs. If your company has 14 sites across the country it is unreasonable to assume one RP can manage all these sites, therefore a RP in each site may be required depending on the nature of the company as well as the scope of the licensed activities. They may report to a centrally appointed RP for consistency and management purposes.

Question 2.5: Which entities need a RP?
Answer: All WDA holders must have a RP.

Question 2.6: Can the provisions between RP and Deputy RP be described in the Site Master File?
Answer: Yes.

Question 2.7: Concerning annual training review of non-operation staff performing GDP tasks: is it mandatory that the RP review, document and sign this review or can it be delegated to QA personnel?
Answer: The RP is responsible for ensuring that initial and continuous training programmes are implemented and maintained. How they conduct this is possible through a number of different means and does not always mean that they must sign individual reviews. A review of the entire process may be conducted through, for example self inspection.

Question 2.8: In your experience, is there a background/profile that tends to be conducive for being successful in the role of a RP - e.g. QP experience, people with logistics background, etc.
Answer: This will depend on the nature of the company and the activities being performed. In general, the RP should have experience performing similar activities to the company in question. A broad base of experience is useful as RP's tend to come across issues across the entire supply chain/life-cycle of the product. The best approach (whilst not always practical or possible) may be for the old RP and new RP to have a handover period or for the new RP to have been employed by the company for a period of time prior to taking on the role to ensure they are familiar with the products being wholesaled and operations conducted.

Question 2.9: For the RP role & ongoing competency assessment, which function is best placed to oversee this: HR, Head of QA, Business Leader, ?
Answer: The RP themselves are often well-placed to know the areas where ongoing professional competence and training is required. Assessment of this may be performed and reviewed by HR or the RP's manager. The RP's manager should understand the RP's role and ensure suitable training is provided.

Question 2.10: If we are the contract manufacturer + 3PL for legal manufacturer/legal distributor who should have the RP employee in the organization chart?
Answer: The holder of the WDA is required to have the services of a RP. If this RP is not an employee of the legal entity being the WDA holder, then a contract should be in place between the RP employer and the WDA holder as the RP would be considered a contract RP. This contract should set out the availability of the RP to the WDA holder including the number of days per month etc.


 

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