Pharma
- What applies
- Planning of qualification and validation under EU GMP Annex 15, changes through change control, and the site change as a variation under Regulation (EC) No 1234/2008.
How do project management and a PMO run plant, CAPEX and transfer projects in pharma, biotech and MedTech without qualification or the regulatory path breaking the schedule?
We provide project leadership and PMO for plant and CAPEX projects and support transfers, with construction plan, qualification, validation and regulatory path in one schedule. Annex 15 requires life-cycle planning of qualification and validation; a plan without these steps shows an end date that batch release will not meet.
Overview
Why do plant, CAPEX and transfer projects fail in a GMP environment?
Project leadership and PMO in production, quality and supply · EU GMP Annex 15 · ICH Q10 · ICH Q9(R1) · Regulation (EC) No 1234/2008
Last updated: October 19, 2026
A GMP project is finished only when the first batch has been released. Until then, construction, qualification, validation and the regulatory path run with their own dependencies, and each of them can set the end date.
- The schedule ends at mechanical completion. Annex 15 of the EU GMP Guide requires qualification and validation to be planned, taking the life cycle of facility, process and product into account (No. 1.1). If these steps are missing from the plan, the critical path lies outside the project.
- The quality unit is only the recipient of the project. Annex 15 leaves open to whom validation personnel report, but requires appropriate quality oversight over the whole validation life cycle (No. 1.3). Without a fixed place in planning and the steering committee, QA objections arrive only when protocols are up for approval.
- Design changes bypass change control. Under Annex 15 No. 11.4, planned changes are to be evaluated with quality risk management for their impact on validation, documentation and regulatory status; a decision taken only within the construction project leaves completed qualification open to challenge.
- The regulatory path is missing from the project plan. For medicinal products, a site change usually requires a variation under Regulation (EC) No 1234/2008; for medical devices with a quality management system approved by a notified body under Annex IX, MDR Annex IX Section 2.4 requires that notified body to be informed in advance of planned substantial changes to the quality management system. Both have their own lead times.
Industries
What this means in your industry
Biotech
- What applies
- The same rules as for medicinal products; for a transfer, ICH Q10 names as the goal the transfer of product and process knowledge as the basis for control strategy and validation approach.
Medical Devices
- What applies
- Quality management system under ISO 13485:2016 within the MDR (EU) 2017/745; planned substantial changes to the system go in advance to the notified body that approved the system under Annex IX (Section 2.4); manufacturers without such an approved system are not covered by this duty.
- Who audits
- Where a notified body has approved the quality management system under Annex IX, that notified body: it assesses the planned change and decides whether additional audits are needed.
Services
How we support you
PMO, Governance & Reporting
Setting up a PMO with a steering committee, reporting cadence, risk register and dashboards for project cost and project status; open GMP items belong in the same report as schedule and cost. The quality unit needs a fixed role in it; ICH Q10 Section 2.1 (b)(3) calls for a timely and effective escalation process for quality issues.
How we work together
What it comes down to
A plant, CAPEX or transfer project in a GMP environment is complete only when the first batch has been released. Until then the date depends on construction and commissioning, on qualification and validation under Annex 15 of the EU GMP Guide and on the regulatory path. Each of them can set the end date, and none of them is visible in the construction plan alone.
Annex 15 requires qualification and validation to be planned (No. 1.1) and states that for large and complex projects separate validation plans may enhance clarity (No. 1.6). The project plan references these plans and carries their steps as tasks with dependencies: URS, FAT and SAT, IQ, OQ and PQ, process validation and the approvals in between.
Annex 15 leaves open to whom qualification and validation personnel report. What it requires is appropriate quality oversight over the whole validation life cycle (No. 1.3). In a project this means the quality unit sits on the steering committee, and its review and approval times appear as tasks in the schedule, including for service provider protocols (No. 2.6).
During the project the design changes, and every change hits documents that already exist. Annex 15 Section 11 requires planned changes to be evaluated with quality risk management for their impact on validation, documentation and regulatory status. The project's change register therefore belongs with the site's change control.
A site change adds a path that the project does not control itself: for medicinal products the variation under Regulation (EC) No 1234/2008, for medical devices informing the notified body in advance of planned substantial changes to the quality management system under MDR Annex IX Section 2.4. Its timing belongs in the same plan as process validation.
For transfer projects, ICH Q10 names the goal itself: to transfer product and process knowledge between development and manufacturing or between sites, as the basis for the manufacturing process, control strategy and validation approach (Section 3.1.2). A transfer plan that only moves equipment and documents leaves this part open; in the PMO it is a work package of its own, with acceptance.
| Project type | What else the date of the first batch depends on | Regulation |
|---|---|---|
| New or retrofitted facility | Qualification from URS to PQ, process validation | EU GMP Annex 15, Sections 1 to 5 |
| CAPEX on existing equipment | Change control, requalification | EU GMP Annex 15, Sections 4 and 11 |
| Technology transfer | Knowledge transfer, validation at the receiving site | ICH Q10 Section 3.1.2, EU GMP Annex 15 |
| Site change | Variation or information to the notified body | Regulation (EC) No 1234/2008, MDR Annex IX Section 2.4 |
Our approach
Our approach
Step
Result
01
Project Charter & Scope
Scope, objectives, budget frame, milestones and owners defined, including the regulatory consequences of the investment or site change.
02
Integrated Schedule
Construction, qualification, validation and the regulatory path in one plan with a critical path; project plan and validation plan reference each other.
03
Governance & PMO
Steering committee, reporting cadence, escalation paths and risk register in operation, with the quality unit at the decision table.
04
Execution & Change Control
Progress, cost and open GMP items tracked together, every design change routed through change control under Annex 15 Section 11.
05
Qualification, Validation & Submission
IQ, OQ, PQ and process validation completed, variation or notified body information submitted at the planned time.
06
Handover to Operations
First released batch, closed deviations, documentation handed over and an operation that runs on without the project organization.
Common pitfalls
Where projects commonly fail
Qualification and process validation sit in a second plan that nobody reconciles with the construction plan.
The date of the first batch is then an assumption. Annex 15 No. 1.1 requires these steps to be planned, and in the project they belong in the same schedule as tasks with dependencies.
The quality unit is called in only for protocol approval.
Annex 15 No. 1.3 requires quality oversight over the whole validation life cycle. If QA joins only at the end, its objections arise at the point where every correction hits the critical path.
Supplier and service provider protocols are scheduled without review time.
Under Annex 15 No. 2.6, personnel at the manufacturing site confirm suitability and compliance with internal procedures before such a protocol is approved. Without this task in the plan, IQ stalls although the equipment is installed.
Design changes are decided within the construction project and never reach change control.
Annex 15 No. 11.4 requires planned changes to be evaluated for their impact on validation and regulatory status. A change known only to construction and procurement leaves completed IQ and OQ documentation open to challenge and can surface at the inspection.
The status report shows schedule and budget but no open GMP items.
Deviations, pending protocol approvals and open questions on the submission then stay invisible until shortly before release. ICH Q10 calls for a timely and effective escalation process that raises quality issues to the appropriate levels of management (Section 2.1 (b)(3)); in a project it should run through the status report and the steering committee.
Supply Chain & Technical Operations
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
A project management office brings together planning, reporting, the risk and action register and the preparation of steering committee decisions. In a GMP project it tracks open quality items alongside schedule and budget: protocol approvals, deviations, change requests and the status of the submission to the authority or notified body.
Qualification and validation become part of the schedule. Annex 15 requires them to be planned (No. 1.1) and mentions separate validation plans for large and complex projects (No. 1.6); the project plan references them and carries URS, FAT, SAT, IQ, OQ, PQ and process validation as tasks with dependencies. Review and approval times of the quality unit appear as tasks of their own, and the plan gains time through the justified use of FAT tests under Annex 15 No. 3.6, not through tests left out.
The regulatory path joins the construction and qualification plan. For medicinal products, a site change usually requires a variation under Regulation (EC) No 1234/2008 as amended by Delegated Regulation (EU) 2024/1701; its type (IA, IB or II, depending on the change) and its procedure help set the date of the first commercial batch. For medical devices, where a notified body has approved the quality management system under Annex IX, MDR Annex IX Section 2.4 requires that notified body to be informed in advance of planned substantial changes to the quality management system.
The manufacturer, through its pharmaceutical quality system. ICH Q10 assigns to senior management the definition of roles, responsibilities and resources (Sections 2.1 and 2.4), and qualification and validation documents are approved by whoever the quality system designates for this (Annex 15 No. 2.2). An external project lead manages schedules, interfaces and decision papers.
Both happen. We take on the project lead or the PMO, as a project with plan, deadlines, escalation and reporting to the steering committee, or on an interim basis when the role is missing in house. For a client's project management we have built dashboards and reporting for project cost and project status. Which form fits depends on who decides in the steering committee and who approves which documents; that belongs in the project charter before the start.
Sources
- EU GMP Guide (EudraLex Volume 4), Annex 15: Qualification and Validation, version of March 2015, Nos. 1.1 to 1.7, 2.2, 2.6, 3.6 and 11.4 (primary text)
- ICH Q10: Pharmaceutical Quality System, Step 4, Sections 1.6, 2.1, 2.4, 3.1.2 and 3.2.3 (primary text)
- ICH Q9(R1): Quality Risk Management (primary text)
- Regulation (EC) No 1234/2008 and Delegated Regulation (EU) 2024/1701 (primary texts)
- Regulation (EU) 2017/745 (MDR), Annex IX Section 2.4 (primary text)
- ISO 13485:2016, primary standard
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Projects from this industry
What we have worked on in this industry
Related insights
All insights →Regulations & standards considered
- EU GMP Guide, Annex 15 (Qualification and Validation), Sections 1, 2 and 11
- ICH Q10 (Pharmaceutical Quality System)
- ICH Q9(R1) (Quality Risk Management)
- Regulation (EC) No 1234/2008 as amended by Delegated Regulation (EU) 2024/1701 (variations to marketing authorizations)
- EU 2017/745 (MDR), Annex IX Section 2.4 (planned substantial changes to the quality management system)
- ISO 13485:2016 (quality management system for medical devices)
Related topics
CAPEX Planning & Qualification →
URS, tendering, FAT and SAT for regulated production facilities
Production Transfer & Scale-Up →
Technology transfer between sites with variation strategy and PPQ
GMP Facility Qualification & CQV →
Qualification master plan and IQ, OQ, PQ in parallel with construction
Interim Management →
Project and specialist roles on an interim basis, with handover to operations
Change Management →
Change control for changes to validated facilities and processes
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