When is interim the right form and when is functional sourcing, if a regulated function is unfilled?
We fill regulated functions in three forms: interim for a vacancy, team extension alongside your own staff, and functional sourcing for an entire process. Responsibility always stays with the marketing authorization holder, and the contract has to reflect exactly that.
Overview
Why does outsourcing a regulated function fail?
Interim staffing, team extension and functional sourcing · outsourced activities under Chapter 7 of the EU GMP Guide and Chapter 7 of the GDP guidelines · QPPV under Art. 104(3) of Directive 2001/83/EC · outsourced processes under MDR Art. 10(9) and EN ISO 13485 section 4.1.5
Last updated: September 16, 2026
An unfilled regulated function is rarely a staffing matter alone. It hits deadlines, releases and inspection readiness at the same time, and the form you choose decides much of the outcome.
- Responsibility is believed to move with the work. Under Article 23 of Directive 2001/83/EC the marketing authorization holder remains responsible, and Chapter 7 of the EU GMP Guide expressly assigns the assessment of the contract acceptor to the contract giver.
- The written agreement is missing or too general. Chapter 7 requires a contract that names the duties of both parties, the responsibilities and the lines of communication; without that split, every deviation turns into a question of who decides.
- The contractual form does not match how the work is actually done. Anyone who directs a person within their own team is within the scope of the German AÜG; anyone ordering a defined deliverable needs a different construction.
- The way back is not planned. Without handover, maintained documentation and a briefed successor, the end of the term recreates exactly the gap the assignment was meant to close.
Services
How we support you
Functional sourcing of a process
Taking over a defined process for the duration, such as change notifications, renewals or reporting obligations, measured against agreed indicators for timeliness and quality.
Contract, quality agreement and delineation
Setting up the written agreement under Chapter 7 of the EU GMP Guide, and the control of outsourced processes under EN ISO 13485 section 4.1.5 and MDR Article 10(9).
Handover and transition back
A planned ending rather than an abrupt one: documented status, a briefed successor and the process returned in house where the assignment was meant to be temporary.
How we work together
What it comes down to
The question is rarely whether a regulated function gets external support, but in what form. Three forms occur, and they differ less in price than in accountability: interim fills a position and follows your division of work, team extension places capacity alongside your team, and functional sourcing takes over a defined process together with accountability for running it.
What stays the same in all three is regulatory responsibility. Article 23 of Directive 2001/83/EC keeps it with the marketing authorization holder, Chapter 7 of the EU GMP Guide assigns assessment and oversight of the contract acceptor to the contract giver, and ICH E6(R3) keeps the sponsor accountable for duties it has transferred. What is outsourced is execution, never responsibility.
The third question is the uncomfortable one and is asked least often before the assignment starts: does the contractual form match the practice? Anyone working under another company's direction inside its team falls within the scope of the German AÜG, whatever the contract is headed. That classification belongs at the beginning, because later it is no longer settled in the project but in an audit.
Our approach
Our approach
Step
Result
Need and delineation
A described scope naming the tasks that move across and those that stay in house.
Form and contract
An agreed form from interim to functional sourcing, with a matching contractual construction and written agreement.
Selection and onboarding
A named person or team, briefed on your processes, systems and applicable standard operating procedures.
Operation against indicators
Ongoing operation with agreed indicators for timeliness, quality and availability.
Audit and inspection readiness
Demonstrable responsibilities, training records and documentation that holds up in an inspection.
Handover
Documented status, a briefed successor and a recorded end of responsibility.
Common pitfalls
Where projects commonly fail
Outsourcing is read as a transfer of responsibility.
Under Article 23 of Directive 2001/83/EC the marketing authorization holder remains accountable, and under ICH E6(R3) the sponsor remains responsible even for duties it has transferred.
The written agreement lists services but not responsibilities.
Chapter 7 of the EU GMP Guide requires the duties of both parties to be described; without that, nobody decides on a deviation when one occurs.
The person works under day-to-day direction while the contract describes a deliverable.
In Germany that is the delineation question of the AÜG, and it is not settled during the project but during an audit.
A named role is filled without checking its preconditions.
Under Article 104(3) of Directive 2001/83/EC the QPPV must reside and operate in the Union, and the Qualified Person needs the qualification set out in Article 49.
The end of the term is not part of the assignment.
Without handover and maintained documentation the gap returns, and knowledge about open commitments leaves the building with the person.
Regulatory Affairs
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- EU GMP Guide, Chapter 7: Outsourced Activities
- EU GMP Guide, Annex 16: Certification by a Qualified Person and Batch Release
- Directive 2001/83/EC, Articles 23, 49 and 104
- Commission Implementing Regulation (EU) No 520/2012
- Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01), Chapter 7
- Regulation (EU) 2017/745 (MDR), Article 10
- EN ISO 13485:2016, section 4.1.5
- ICH E6(R3): Guideline for Good Clinical Practice (Step 4 of 6 January 2025)
- German Temporary Employment Act (AÜG), primary text
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All insights →Regulations & standards considered
- EU GMP Guide, Chapter 7 (outsourced activities: contract giver, contract acceptor, written agreement)
- Directive 2001/83/EC, Article 23 (continuing responsibility of the marketing authorization holder)
- Directive 2001/83/EC, Article 104(3) (QPPV residing and operating in the Union)
- Commission Implementing Regulation (EU) No 520/2012 (pharmacovigilance tasks and their delegation)
- GDP guidelines 2013/C 343/01, Chapter 7 (outsourced activities in distribution)
- EU GMP Guide, Annex 16 (certification by the Qualified Person)
- EU 2017/745 (MDR), Article 10(9) (the quality management system covers outsourced processes)
- EN ISO 13485:2016, section 4.1.5 (control of outsourced processes)
- ICH E6(R3) (transfer of duties to a contractor, responsibility remains with the sponsor)
- German Temporary Employment Act, AÜG (distinguishing service and works contracts from staff leasing in Germany)
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Have a concrete project?
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