Many companies are unable to provide their own Responsible Person and turn to a Contract Responsible Person to help manage and support their GDP Quality management system.
When selecting your Contract Responsible Person, how should you go about it?
Opinions vary, but many will pick a person they know, or is known by a trusted friend or contact.
Whether you know or like someone, are they fit to do the job? How do you validate this third party?
We were told by one client that they got support from someone who had “been to the MHRA symposia, and really knows their stuff… oh, they didn’t go last year, but did go the year before.”
Sound like a good pick? Possibly, but in this case definitely not.
Some will Google search the terms Responsible Person or Contract Responsible Person (Or Contract RP’s Deputy) and short list based on experience, or often costs.
How should you find your next Contract Responsible Person or RP’s Deputy, and what makes the most sense for your operation?
The Contract Responsible Person should ideally not have a commercial interest in the business, especially if it impairs decision making, or risks compromise. Public health and medicinal quality must come first, and products that are found to be unsafe or deviated outside of label conditions should be destroyed, if that is the manufacturers recommendation.
Some think that this is a conflict with the RP Gold Standard which states that the RP should
|practise continuous improvement practices and utilise appropriate tools and techniques to solve problems|
Proper paperwork, reporting and recording needs to happen at every stage of the process, to evidence during your inspections, and be subject to CAPA and Risk Assessment principles, to identify and ideally reduce/eliminate recurrence.
The focus on quality of product is critical, and your Quality Management System, and other procedures, are what will make or break your business.
Are you experienced enough to manage this alone, or do you need guidance?
Paradigm Shift Consulting have a team of Contract RPs/Contract Responsible Persons and Contract RP’s Deputy, who can assist you with advice, audit support and review and editing of your QMS/SOPs, but as you retain the full responsibility, are a lesser cost.
For those who know their GDP (Good Distribution Practice), the Deputy can be a useful tool, to bounce questions off them or for them to carry out certain duties or act as a double check.
The Deputy can also work with you to upskill your staff, offer training and support.
If you prefer regulatory support we offer a range of cost effective monthly service models, where we can help with the little things, or those big and nasty jobs.
Whatever you need, help for a day, help for a month, an annual contract, or ad hoc work, we can assist you.
If you would like some support with Change Control, Deviations, Corrective and Preventive actions, Quality Management Meetings, or self-inspections we can supply Contract Responsible Persons or Contracted Deputies to help support you and give better GDP compliance.
When you are hiring your Contract Responsible Person ask for personal and professional references. Ensure that they are there to support you and your business, and not just there to make money out of you.
We offer solutions to fit all pockets, and all models. A pharmacy wholesaler, collecting a few branded products, requires far less support than a wholesale exporting worldwide and sending cold chain shipments.
Not all Contract Responsible Persons are made the same, and we will do our best to place an associate with you who will help you achieve your goals and ensure GDP compliance.
Contact us for a no obligation chat, via our contact page.
Welcome to a new paradigm!
2 Apr 2019
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12 Feb 2019
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