De Jong Pharma Consult as your Responsible Person? 5 Reasons why!
On 21 and 22 November 2018, De Jong Pharma Consult completed the training for Responsible Person for the Good Distribution Practices for medicinal products for human use. This intensive course, provided by PCS is one of the few courses recognized by the Dutch Health Authority and therefore required for everyone that want to be registered as a Responsible Person.
As the course is an open training, anyone can take the course and register. So why use a professional?
This is why you should hire a contractor as a Responsible Person instead of assigning a ‘volunteer’.
1: The responsible person may delegate duties but not responsibilities
One of the explicit parts in the GDP guideline stipulates that the responsible person may delegate duties but not responsibilities. This means that, although tasks can be performed by other staff, the RP should always have knowledge and control over the quality system and the issues that are present in the organization.
In smaller organizations, non-dedicated RP’s have other tasks and responsibilities. Not only can they conflict with the RP’s responsibilities, they may also receive more priority from an staff member that has the RP responsibilities assigned to them. Even in large organizations we’ve seen RP’s who have no clue of what is going on, just because they are too busy with other duties. We also see that during Health Authority Inspections, companies will own up.
Hiring a professional RP ensures an independent focus on the tasks and responsibilities of the RP. No distraction by other tasks, priorities or interests.
2: Self-inspections should be conducted in an impartial and detailed way by designated competent company personnel.
The GDP guidance has a very specific section on Self-inspections in chapter 8.2:
Self-inspections should be conducted in an impartial and detailed way by designated competent company personnel. Audits by independent external experts may also be useful but may not be used as a substitute for self-inspection.
This is interpreted by the Dutch Health Authority as: your own staff should conduct the self-inspections or internal audits. This may be done by a contract RP.
Internal auditing is a specific skill not everyone is comfortable with. By hiring De Jong Pharma Consult as your RP, you bring in the full auditing experience of a seasoned audit professional. In this manner you kill two birds with one stone.
3: Experience, Experience, Experience
By hiring a professional RP, your organization immediately obtains the vast experience available which is held by the professional RP. Since the professional RP performs these tasks and responsibilities in other organizations, and has done so over time, mistakes can be prevented and best practices are easily implemented.
The experience provided also enables the contract RP to work part-time for your organization, helping cost management. Depending on the size and scope of an organization, a contract RP can be available for a 1/2 day per week.
As we have functioned as Deputy Responsible Person for years, this experience has been obtained. Together with our auditing experience, we bring all the experience you need. We also have experience to perform the duties and responsibilities in a relative short amount of time, 1/2 or a full day per week.
4: But be ware of the pitfalls
Hiring a contractor to get your system up and running, well organized and compliant, sounds very attractive but also expensive. Easy to get the contractor to set things up and then taking over yourself to save money.
This may sound attractive but dismisses the advantages of the professional RP. Who is going to maintain the quality system, who is going to perform the independent self-inspections, who is going to provide the neutral, patient centered and compliant voice in the day-to-day operations.
Better to establish a long term relationship with your contract RP to ensure familiarity of products and systems in both directions.
5: Also for Active Pharmaceutical Ingredients
Guideline 2015 / C 95/01 of 19 March 2015 prescribes mandatory measures for Good Distribution Practices for active substances for Medicinal Products for human use. The guideline stipulates that all distributors of active pharmaceutical ingredients used in medicines for human use, must have a ‘designated person’ in order to secure the implementation of the GDP guidelines.
The guideline gives little detail of what this Designated Person should be able to do and what the responsibilities are, only a general text is available.
That is why it is all the more important to bring in an experienced professional to make and keep your quality system compliant. We extensive experience and are therefore your partner in a secure supply chain.
With the obtained certificate we can now be registered as your Responsible Person (or Designated Person).
This last step brings the experience we have and the formal Health Authority requirements together to benefit your organization.