Preventing Typical Challenges in GMP Projects
When a pharmaceutical company invests in a new aseptic filling line, the project usually starts with great enthusiasm. The mechanical engineering company's sales team celebrates the contract award and the opportunity to implement innovative technologies. Procurement is satisfied with an ambitious timeline and attractive commercial conditions. On both sides, project managers start the collaboration highly motivated.
Accordingly, the kick-off meeting is characterized by a spirit of optimism. Open questions from the proposal phase are deliberately postponed, and critical issues are not yet discussed in depth. However, once operational project work begins, familiar areas of tension emerge. The URS is reinterpreted, additional stakeholders introduce new requirements, and technical innovations prove to be less mature than initially assumed. The schedule comes under pressure, and change orders become necessary - even though they were not foreseen organizationally or budget-wise.
As the project progresses, frustration and mistrust increase. Feedback is delayed, change requests are scrutinized critically, and acceptance activities take longer than expected. Either unpleasant surprises arise during FAT, or the equipment is released pre- maturely - only for the problems to manifest later during SAT. Resources are tied up unexpectedly, costs rise, and escalations increase. For project teams, this means constant stress - especially when employees manage several such projects in parallel. In the end, there is often a technically impressive machine, but both sides leave the project exhausted and dissatisfied.
Yet many of these friction losses can be avoided. What is decisive is a structured project approach with clear guardrails, transparent communication, and the courage to address critical topics openly at an early stage.
A key element is professionally established risk management. At the start of the project, a prioritized risk analysis should be developed jointly and updated regularly. Risks must not remain abstract; they need to be linked to concrete impacts on schedule, cost, and quality. Clearly defined escalation paths are equally important, allowing issues to be addressed at the appropriate decision-making level before they block the project.
The importance of effective risk management was demonstrated in an international project where SAT was delayed by several weeks because packaging materials had been changed at short notice from different suppliers. Only at a late stage did it become apparent that siliconization and friction coefficients did not meet specifications. The customer had not realized that production- grade materials were required. A prioritized risk assessment early in the project would have made this scenario visible and enabled alternative sourcing strategies in time.
Attention should also be paid to team transitions during the project lifecycle. Handovers from sales to the project team, from generalists to subject-matter experts, or later to operators almost inevitably lead to new interpretations of requirements. What was described in the proposal phase as "to be defined later" may suddenly become critical during commissioning. To avoid such discontinuities, key requirements - especially within the URS - should be actively maintained throughout the project and jointly reviewed at every handover point. Structured handover workshops, documented decision rationales, and clearly defined responsibilities help secure knowledge and prevent discussions from starting over repeatedly.
Recommendation
9 June 2026
Drug Shortage Policy in the EU: How to deal with Regulatory Requirements? - Live Online Training
In one international project, initial project responsibility lay with a U.S. team that had focused on maximum flexibility and functional diversity in the equipment design. After delivery to the operator in Europe, local project managers took over. Their primary focus was on operability and EHS requirements. This led to intensive discussions and numerous modifications under time pressure. Early involvement of the operator's organization, along with clearly documented decision bases regarding trade-offs and priorities, could have significantly reduced these conflicts.
Unrealistic or uncoordinated schedules are also among the greatest stress factors in filling line projects. Machines are often delivered although buildings are not yet completed, or customers do not yet require the equipment while critical engineering decisions - such as utility connection points or piping lengths - are still missing on the supplier side. Such conflicts can only be mitigated through integrated master schedules in which construction progress, supplier activities, document approvals, and qualification phases are realistically aligned. Project managers should insist early on that missing boundary conditions are made transparent and that decision needs are clearly scheduled, rather than implicitly shifting them into later project phases.
In the above-mentioned project example, the production facility was still in the planning phase while the customer already required reliable data on utility consumption to design its infrastructure. As the final positions of the machine's utility connections had not yet been defined, consumption values could only be calculated based on assumptions. Depending on the connection layout, additional pumps were required, which in turn affected exhaust air volumes and building systems. Only through repeated joint reviews, transparent scenario calculations, and clear identification of the schedule implications of modifications - either to the equipment or to the building - was a sound basis for decision-making established.
Uncertainties also arise when open issues at FAT are not consistently assessed or when machines are "simply shipped" although central topics remain unresolved. An effective counter measure is to establish the URS as a living control instrument and actively reference it in every project meeting. Acceptance should only take place once defined criteria are fulfilled and remaining items are transparently documented and evaluated in terms of timeline impact. On the customer side, it may also be beneficial to deliberately build basic technical understanding so that attention is not focused on minor details while critical topics are overlooked.
Intercultural differences often further intensify these challenges. International projects require not only training for the project manager but a shared understanding throughout the entire organisation. Different communication styles, expectations, and decision-making processes must be openly addressed and translated into clear project rules. For example, if it is known that a customer communicates change requests indirectly or expects a consultative role from the supplier, project processes should be adapted accordingly to avoid misunderstandings.
Recommendation
16-18 June 2026
GMPs for Equipment, Utilities and Facilities - Live Online Training
Another classic stumbling block is unclear interfaces. Questions regarding packaging materials, products, formats, drawings, or approval processes must not be postponed. Especially when two organisations with different workflows are brought together, it is essential to structure and clearly define these interfaces at an early stage. Interface matrices, decision lists, and schedules for critical supplied components create transparency and prevent costly rework.
Ultimately, projects involving aseptic filling lines rarely proceed linearly. Revisiting the URS, restarting individual sub-projects, or escalating issues early can be necessary and constructive. What matters most is consistent alignment with the specific customer, robust interface management, open communication, and a deep understanding of different roles, cultures, and perspectives. Those who internalize these principles not only reduce project stress but significantly increase the likelihood that, in the end, not only a good machine - but also a good project - is remembered.
About the Author
Sabine Wildenhain is a freelance project manager and founder of EMI Project Management. She has been supporting complex pharmaceutical and life science projects for over 10 years.
