GMP & GDP Qualified & Responsible Persons.
Supporting your GMP & GDP obligations.

What are GMP & GDP Qualified & Responsible Persons?

Qualified & Responsible Persons are both roles that are mandated by legislation by Good Manufacturing Practices (GMP) guidelines and Good Distribution Practice (GDP) guidelines. GMP places a stronger emphasis on the responsibilities of the Qualified Person (QP), whereas GDP highlights the role of the Responsible Person.

While these roles share similarities, they are distinct, with specific responsibilities outlined in the relevant guidance for GMP and GDP. For instance, an RP is not authorized to certify the release of a product batch, whereas a QP can. A QP is usually required to have further certification, which reflects the legal and safety importance attached to batch release.

Both roles typically fall under the wider umbrella position of Technical Director, where this would require being a QP in manufacturing and an RP in distribution amongst other duties, but only the requirements for these two roles fall under regulatory requirements.

Qualified Persons.

According to European Law, it is mandatory to designate a Qualified Person (QP) to authenticate batches of any Medicinal Product before its utilization in clinical trials, distribution for sale within the EU, or export.

A QP is required to demonstrate ongoing training in the specific product type, production procedures, technological advancements, and modifications to GMP guidelines. Additionally, they must ensure compliance with the requirements and conditions of the legislation in each member state where they operate.

The QP must be listed on the Manufacturing and Import Authorization (MIA) as the individual responsible for the specified operations at the authorized manufacturing or certification site in question.

In the event of a quality issue or batch recall, the QP(s) involved in certifying a manufactured batch of medicinal products must be readily identifiable.

 

Responsibilities of a Qualified Person.

Whilst the primary responsibility of a QP is to certify batches of Medicinal products before their use, they also have additional responsibilities including:

  • Ensuring that all activities and materials comply with Marketing Authorization (MA) and adhere to GMP principles and guidelines.
  • Establishing and maintaining a current and active Quality Management System (QMS) along with a self-inspection program.
  • Documenting the entire supply chain up to the certification point, ensuring products are distributed in accordance with GDP guidelines.
  • Conducting audits of all relevant sites, confirming compliance with the MA, and ensuring that Quality/Technical Agreements are in place, with all records being complete and endorsed by appropriate personnel, including in-process controls.
  • Evaluating the impact of any changes to manufacturing or testing and completing additional checks as necessary.
  • Ensuring any deviations from GMP regulations are identified, documented, and investigated, and that corrective actions are taken to prevent a recurrence.
  • Ensuring that all investigations related to the batch have been sufficiently concluded, and that any ongoing complaints, investigations, or recalls do not compromise the conditions for the certification of the current batch.

Click here for more information from the European Commission on QP GMP Certification and Batch Release.

Responsible Persons.

European Good Distribution Practice (GDP) Guidelines require wholesale distributors to designate a Responsible Person (RP) to manage the risks associated with inadequate or substandard product distribution processes.

Like Qualified Persons (QPs), RPs are required to be knowledgeable in GDP guidelines, conduct regular GDP training, and possess a thorough understanding of the company’s licensed activities and procedures.

RPs must also satisfy the legislative qualifications and conditions required by the member state issuing the Wholesale Distribution Authorization (WDA), and have prior experience in overseeing, controlling, and managing the wholesale distribution of medicinal products.

They must have knowledge in a range of areas including the product, its authorisation status, serialisation requirements, storage requirements, the entire supply chain, agreements with third parties, and the Quality Management System (QMS).

 

Responsibilities of a Responsible Person.

In addition to ensuring compliance with GDP regulations, RPs have additional responsibilities including:

  • Ensuring adherence to Wholesale Distribution Authorization (WDA) requirements and regulations, including the creation of precise and comprehensive quality records.
  • Implementing and sustaining the quality system, approving, and signing relevant Standard Operating Procedures (SOPs).
  • Supervising WDA and GDP training programs.
  • Ensuring products are transported, stored, and delivered according to the license.
  • Ensuring products are not tampered with, stolen, or counterfeited during distribution.
  • Ensuring products are properly labelled and that all necessary documentation is completed and maintained.
  • Ensuring any deviations from GDP regulations are identified, documented, and investigated, and that corrective actions are taken to prevent a recurrence.
  • All personnel involved in the distribution process are trained and competent in GDP regulations.
  • All records related to the distribution process are complete, accurate and maintained.
  • Coordinating recalls at the site and addressing customer complaints.
  • Overseeing self-inspections/audits and deciding the actions with returned, rejected, recalled, or falsified medicinal products.

 

Click here for more information from the European Commission on Wholesale Distribution and RPs within GDP guidelines.

Why choose Aegisana’s Qualified & Responsible Persons services?

Responding to your needs.

Aegisana’s Compliance team is fully experienced with the legislative and operational requirements of Qualified & Responsible Persons under GMP and GDP.

We can provide a fully outsourced person for each role or provide support service to your internal QPs and RPs in these roles.

We understand the importance of Qualified and Responsible Persons in relation to compliance and patient safety, alongside the part they play in the release and supply of your products and their commercial realization.

Confidence from experience.

Our objective is to provide you with peace of mind and confidence that comes from knowing our services to you as QPs, RPs, or in support to these roles are being led by an experienced team who have previously acted in these roles internally and understand the operational requirements of manufacturing and distribution.

We hope to establish a successful and robust strategic and operational compliance partnership, grounded in effective communication, reliability, and trust. Our comprehensive support extends across all our service areas, providing expert solutions throughout the entire life cycle of your human and animal products.

Typical areas included as Functional Service Provision or as support services include:

GMP Auditing.

 

Qualified Person (GMP).

GDP Auditing.

 

Responsible Person (GDP).

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.