Although pharmaceutical companies invest heavily in strategy, planning, and regulatory compliance, persistent implementation problems repeatedly arise, specifically in these areas:
Here are some customer issues from our practice over the last twelve months:
If you recognise these problems:
You are not alone. These problems occur frequently and are not strategic problems, but Implementation problems.
You are failing because the implementation breaks down under pressure. The immediate consequences are:
A delayed pharmaceutical project is not simply a project that runs a few days or weeks overtime. The delay is not neutral. The risk does not increase linearly with time. This means that a delay of 10–20 % means a risk increase of far more than 10–20 % for GMP compliance and for turnover.
To improve the implementation of pharmaceutical projects, it is crucial to understand,
where these delays actually come from. In most cases that we see in our practice,
the roots of the problems lie not in the technical part, but in the operational implementation.
This happens even though, in the run-up to projects, the discussion mainly focuses on the technical implementation, including the planning software to be used. However, the real reasons are different.
We very often see that the teams in MSAT and QA are overloaded. In the GMP environment in which pharmaceutical companies operate, many projects have a technical or regulatory background. Therefore, these two departments must process them.
These teams are responsible for, among other things:
In addition to their standard tasks, they are also involved in high-priority projects.
The result is then:
Reactive decision-making, meaning decisions are only made after the deadline has passed and not as early as possible. Problems are dealt with late and therefore also solved late.
This is visible but cannot be switched off.
Many delays in pharmaceutical manufacturing and their projects are rooted in a lack of, or failure to carry out, coordination between various functions. It very rarely comes down to scientific or technical challenges.
Typical problem patterns include, for example:
This leads to these symptoms:
Most delays in the pharmaceutical industry do not arise from technical errors or defects. They are in reality coordination problems between crucial departments and functions.
Outsourcing manufacturing or technology transfer to a contract development and manufacturing organisation (CDMO) is typically done to reduce production costs. Companies often overlook that the complexity of coordination increases as a result.
Why is that?
Outsourcing production does not mean outsourcing responsibility. Common problems when working with contract manufacturers include, for example:
Without strong management and good coordination of „third parties“, pharmaceutical companies easily lose control over manufacturing and release at contract manufacturers. This is critical as the customer still bears product responsibility.
Delayed validations are often a significant reason for delays in transfer projects. We frequently see the causes in these areas:
The entire GMP timeline is falling behind and needs to be postponed (for example, the submission deadline for dossier amendments).
In many cases, validation does not take a long time due to high complexity or technical difficulties, but because the coordination between departments functions poorly or occurs too late. A common phenomenon is extremely long review cycles for validation documents, which sometimes drag on for months.
When projects go awry, organisations bring in external consultants. However, with traditional consulting, they often bring additional problems in-house:
Delayed pharmaceutical projects are often considered a purely planning problem, easily rectifiable by a change in schedule. In reality, however, they have far-reaching operational and strategic consequences, as well as financial implications:
Deviations require extensive documentation and coordination; these are often points of attack during inspections and audits. Every unplanned activity that needs to be documented and improved increases the risk of audit problems.
Organisational impact
When pharma projects fall behind schedule, organisations typically deploy these countermeasures:
These approaches mostly don't work because they don't solve the root of the problem:
The problem isn't the use of resources – it's the implementation.
Highly effective external experts do not act as consultants. They operate as an integrated decision-making level within pharmaceutical projects.
Quick identification of bottlenecks
Experienced pharma consultants identify very quickly:
where implementation is blocked
where unclear decisions are made
where risks are accumulating
Thanks to their experience, they only need days for this, not months.
Practical experience in transfer implementation. Unlike traditional consultancy firms, external experts operate differently:
Coordination between different departments and functions
Effective external experts bridge differing views in departments such as:
They achieve this because they have themselves worked operationally in these functions and departments. This coordination reduces waste and duplication of processes and ensures consistent decision-making.
Control over CMOs and Third-Party Management„
Independent consultants with experience deliver the following advantages:
Das wandelt Outsourcing-Projekte von einem reaktiven Projektmanagement um in ein proaktives Projektmanagement.
into an actively managed project.
Build GMP compliance in from the start
Instead of discussing compliance late on, external experts act like this:
When should pharmaceutical companies seek external support? Timing is crucial. Many organisations wait until projects are in an almost irrecoverable state before acting.
Please note these warning signs:
If you observe several of these warning signs, it is high time to act.
If your current projects are showing these patterns, you are already experiencing delays and risk further ones. In most cases, these issues can be corrected, but only if implementation bottlenecks are quickly identified and addressed directly.
The advantage of acting quickly
A delayed intervention, on the other hand, leads to:
Increased costs
Additional points of attack in inspections and audits
A significantly more complicated recovery
Execution determines success.
Many pharmaceutical companies do not lack expertise.
You lack the ability to perform under pressure.
Projects are successful if:
experienced implementation experts who work within the process, not outside of it.
Most delayed pharmaceutical projects can be turned around.
However, not within the structure that caused these delays.
An implementation-focused external approach can:
Dr Georg Astl is the founder of Eoswiss Pharma. He is the author of numerous specialist articles and a speaker at professional events.
Pharma projects can be implemented faster if bottlenecks in execution are identified early and addressed directly. Clear responsibilities, close coordination between MSAT, QA, and production, and active management of CDMOs are crucial. This significantly reduces delays in technology transfer and validation.
GMP projects are frequently delayed due to overloaded MSAT and QA teams, a lack of coordination between departments, and insufficient oversight of external partners like CDMOs. These factors lead to delays in technology transfer, validation, and batch release, whilst simultaneously increasing compliance risk.
GMP risks can be reduced if quality requirements are integrated into the implementation from the outset. This includes close coordination between QA, MSAT, and manufacturing, as well as consistent documentation throughout the real process. Early identification of deviations prevents problems during audits and inspections.
Collaboration with CDMOs improves through clear governance structures, transparent communication, and active management of external partners. It is important that progress, risks, and responsibilities are continuously monitored to avoid delays and quality issues.
External experts are useful when projects are delayed, validations fail, or internal teams are overloaded. They help to quickly identify bottlenecks, accelerate decision-making, and bring projects back under control.
Technology transfer can be accelerated by clear process definitions, early alignment between MSAT, QA and production, and structured management of CDMOs. It is crucial to identify and actively manage risks early on, rather than reacting to them.