Contract Responsible Person

The Responsible Person, abbreviated as RP, is mandated by the EU GDP regulations. The Responsible Person is responsible for most Quality affairs within the company. These responsibilities include; maintaining the Quality Management System, performing recalls, ensuring staff is trained and deciding on the fate of returned products (amongst others).
The Responsible Person is contracted or employed by the warehouse or trader of medicinal products. Although there is a financial relationship, the Responsible Person is independent. Decisions on releasing products from the warehouse, return or quarantine should not be corrupted by commercial motives.

What is a Responsible Person?

  • Responsible person’s job requires expertise in various areas. What are the advantages of having a professional Responsible Person (RP)?

    1. It is the professional Responsible Person’s full time job to keep track of the ever-changing UK and EU legislation, making sure that they are familiar with the legislative updates so that customers’ cosmetic products remain compliant with the UK and/or EU legislation.
    2. Responsible Person provides the clients with regulatory advice and thanks to their expertise they are able to provide answers faster and more accurately. A professional RP can be your single point of contact for any regulatory issue in the UK and/or EU. RP experts in the field help clients to compile the Product Information File faster, ensuring that the file is fully compliant with the Regulation.
    3. A professional Responsible Person (RP) is proficient in the use of the local drug portal or local health authority notification process, they perform product notifications faster and without errors.
    4. Even if you change your distributor, your Responsible Person (RP) remains the same, eliminating the need to reprint your labels (labels have to state the name and address of the Responsible Person) and the need to notify your products once again.
    5. A professional Responsible person can easily answer the questions that the UK or EU competent authorities might have, and handle any crisis that might arise.
    6. You can be sure that a professional Responsible Person will treat your Product Information Files with care, keeping the information confidential. The files will be kept for 10 years the date of placing the last batch on the UK or EU market
    7. A professional Responsible Person’s task is to ensure the compliance of your products at all times.
  • The Responsible Person is responsible for ensuring the safety of the medicinal products throughout storage and distribution, and is your key contact.

    In the new GDP guidelines, the 12 listed duties of the Responsible Person are as follows:

    1. Ensuring that a quality management system is implemented and maintained;
    2. Focusing on the management of authorised activities and the accuracy and quality of records;
    3. Ensuring that initial and continuous training programmes are implemented and maintained;
    4. Coordinating and promptly performing any recall operations for medicinal products;
    5. Ensuring that relevant customer complaints are dealt with effectively;
    6. Ensuring that suppliers and customers are approved;
    7. Approving any subcontracted activities which may impact on GDP;
    8. Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
    9. Keeping appropriate records of any delegated duties;
    10. Deciding on the final disposition of returned, rejected, recalled or falsified products;
    11. Approving any returns to saleable stock;
    12. Ensuring that any additional requirements imposed on certain products by national law are adhered to.

Why you should hire a GXP WAY Contract Responsible Person (RP)

  • Hiring a Responsible Person is a time consuming process,
  • Finding a suitably qualified and trained Responsible Person is challenging,
  • Contracts are flexible and you only pay for hours worked,
  • Our Responsible Persons are highly experienced.

If you would like to have a conversation about any of the above, please get in touch with us.