Release determines the date
Every change requires change control, qualification and requalification. Planning only the capital project means planning only part of the way to the product.
Industries · Process industry
Pharma & Biotech
We manage shutdowns, capital projects and technology transfers in a GMP environment – with qualification and validation as activities in their own right in the plan.
- GMP
- clear rules, with quality and safety in focus
- Innovation
- drives new plants and capacity
- Transfers
- secure the step into production
- 4 clients
- from this industry on our reference list
Market
Capital projects in a GMP environment
Pharma and biotech invest selectively: in Europe, the focus is mainly on modernisation, expansion and technology transfers. Investment runs along the entire life cycle, from active ingredient production through formulation to final manufacturing, and into resilient supply chains. Competition is about approvals, above all the first approval in each country, and every one requires GMP-compliant manufacturing. Transparent control of all activities therefore becomes a prerequisite.
Regulation sets the framework: cleanroom requirements and complete qualification and documentation are mandatory. Every technical change entails change control, qualification and requalification. For maintenance and projects, this means a shutdown is not just a technical undertaking but a qualified shutdown – planned, documented and approved.
The critical path does not end with qualification here – it runs from the idea to market launch.
Challenges
What is different here
Critical utilities
High-purity utilities, cleanroom technology and HVAC systems have to restart in a qualified state – whether the first batches succeed depends on this commissioning.
Depth of documentation
Complete evidence for audits and inspections. Document Control is a success factor here, not a side issue.
Clear and transparent dates
Products have to be available. Shutdown windows are short and fixed and closely watched – by the operator and by the authorities alike.
Qualified cleanroom areas
Cleanliness classes and access rules shape the sequence, airlock logistics and recommissioning – and with them the pacing of the trades.
Typical tasks
Your task – and what we offer for it
On the left: what operators in this industry come to us with. On the right: the service that covers it.
A qualified shutdown is coming up
Leading the shutdown from definition to closeout – change control, IQ/OQ/PQ and requalification are activities in their own right in the plan.
A technology transfer is coming up
Project leadership or project control for the route into production or to a new site – with qualification and validation as activities in their own right in the plan.
The evidence has to be complete
Version-controlled, audit-proof project documentation – the basis for qualification, release and audit.
The date has to hold
Planning and control across the whole project – progress measured, not estimated.
Is this schedule technically sound?
Measurable schedule quality – for your own plan as well as for those of your contractors and partners.
We are facing an investment decision
A reliable schedule and cost forecast in the early phase – before facts are created.
Leadership is missing on the construction site
Site Management & Construction Management
Leadership on the construction site: trades coordinated, quality documented, punch-list items worked off.
We are short of people for the peak
Planners, site managers and QA/QC staff for expansion, conversion and requalification projects – exactly when you need them.
Clients
Clients from this industry
- Bayer
- BioNTech
- CureVac
- Takeda
A selection of our clients in this industry. View all clients
Related services
Shutdown or project?
In this industry we support you in both worlds. From here you can go on to the services that belong to it.
Turnarounds
From the TAR-Check through scope and scheduling to leading the entire shutdown.
Go to servicesCapital projects
From feasibility through estimating and project controls to site management and overall responsibility.
Go to servicesFrequently asked questions
Questions answered
Does ep-cm take over qualification?
No, we do not perform the qualification ourselves – it is a regulatory role and lies with your quality organisation. We manage it: change control, IQ/OQ/PQ and requalification are separate activities in the schedule, and the schedule covers the project down to the last activity, including approval by the authorities. We track the dates, keep the documentation up to date and make sure that nobody is waiting for a missing piece of evidence.
Why is Document Control so important in pharma?
Because approval depends on the evidence. A project can be technically complete and still not go into operation as long as test records, drawing revisions or acceptances are missing. That is why we keep the documentation up to date throughout the project – from the idea to market launch.
Do you have experience with GMP environments?
Yes. We manage capital and maintenance projects in the pharmaceutical industry in the DACH region and across Europe. Our contribution is control: managing schedule, cost and documents so that the quality organisation can give its approval.
How do you plan the qualified commissioning of critical utilities?
As a project within the project. Ultra-pure utilities, cleanroom and HVAC systems must be returned to operation in a qualified state – with their own activities, their own owners and their own schedule logic. In practice, this part often decides when the shutdown ends.
Do you work on the operator's side and independently?
Yes. We report to the operator, not to an executing trade – ep-cm is owner-managed and does not belong to any group with executing companies. Responsibility for quality also stays with you: your quality organisation qualifies and releases. We support it – with reliable dates and complete evidence.
Terms such as qualification (GMP) and technology transfer are explained in our glossary – along with 57 more terms from the turnaround and project business.
Let’s talk about
your plant.
Get in touch – we will respond within one working day, with people who know this industry. The initial call is free of charge.
Book an initial callPrefer to talk directly? +49 (0)211 5667 7754