The EU Guidance 2013/C 343/01 clearly outlines the 12 duties of an RP (Responsible Person) in Chapter 2.2.
Each of these duties will require the RP to have a high standard of knowledge on Good Distribution Practice; meaning that it is crucial that they have extensive training on all chapters of the EU guidelines as well as other relevant guidelines/legislation, and keep up to date with any changes.
If the RP doesn’t know how to correctly carry out their duties whilst ensuring compliance, the Quality Management System (QMS) will fail, resulting in a number of deviations and deficiencies. Your licence will be suspended if an MHRA inspector is not satisfied with the performance of both the RP and the QMS, which could also result in the removal of the RP.
Some of these duties of an RP include:
– Ensuring an effective QMS is implemented and maintained throughout the company.
– Ensuring that all records are accurate and of a high quality.
– Making certain that bona fides checks are carried out on all suppliers and customers to ensure that they are legitimate companies who are licensed to supply/receive the products.
– Performing (or overseeing) regular self-inspections.
– Deciding on what will happen to any returned, recalled, rejected or (suspected) falsified products.
The RP may delegate some duties to another member of staff who is suitably trained, but the main responsibility will always lie with them, so it is essential that they are involved in all processes/duties at some level.
Training, Backup and Support
At Paradigm we offer a range of services that we believe will help you to ensure that you have an RP who is effective in their duties. This could be with our range of training courses (both online and face-to-face), providing a Contract RP or RP’s Deputy to help you with Good Distribution Practice compliance throughout the company, or carrying out a third-party audit of your site to discover any areas that need improving (and offering advice on how to do this).
We have a number of different compliance support memberships that will give you the opportunity to choose the level of support and number of services you require. There is also the option for you to create a bespoke membership package, where you can choose which of the services available will be the most beneficial for your company.
We run monthly training courses that cover all 10 critical chapters of the EU Guidance, which is a requirement for all RPs before any of their duties begin. It can also be used for refresher training (which is needed annually). If needed we can come to your site to deliver the training, especially if there is a large group.
For more information about the services we provide, to book your place at one of our training courses or if you need help performing the duties of an RP, get in touch with us using the contact form below. You can also overview the Webinar for RPs and Management Course page on the link button provided. The next Webinar date will be shown.
Courses relating to this topic are shown below. To view the wider range of courses on offer, click on the button to visit the GDP Training Courses page.
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Related Courses
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