Cleaning Validation as a Business Enabler
How Progress supported LelyPharma in its ambition to future-proof its cleaning validation framework, a system that moves with the business instead of constraining it.
Progress Experts in Life Sciences recently supported LelyPharma with a large, complex cleaning validation programme. What made this project distinctive was not its size alone, but the way cleaning validation was repositioned, not as a standalone compliance activity, but as an integral part of the company’s business model.
Rather than delivering “just” a validated state, Progress always works with a client to design and implement a system that actively supports the dynamics of a modern Contract Manufacturing Organisation. A system that remains fully compliant, while at the same time enabling agility, faster product introductions and controlled changes to equipment and processes.
At the heart of the approach is a structured modelling framework, where cleaning validation is embedded into business decision-making. Clear assessments are used to evaluate the impact of new products, formulation changes or equipment modifications, allowing informed decisions without unnecessary revalidation. This creates a living system that evolves with the business, instead of constraining it.
A strategic ambition: one harmonised, future-proof framework
LelyPharma set an ambitious strategic objective: to modernise and future-proof its entire cleaning validation framework in one coordinated programme. Operating multiple plants, with fixed and mobile equipment, numerous configuration options and a broad product portfolio, the organisation needed a harmonised approach that strengthened compliance while maintaining operational flexibility.
Progress Experts in Life Sciences were selected as partner to help realise this ambition.
The programme was initiated by managing consultant and Cleaning Validation Specialist Paul Tiemeijer, who introduced a contemporary validation methodology based on modelling principles rather than traditional, campaign-dependent execution. A cleaning validation steering committee was launched, which included the addition of the company’s stakeholders CEO, QA manager, QC manager and the production pharmacist. To ensure strong governance and predictable delivery, Progress senior consultant Thijs Booiman, an experienced project manager, was added to the team. His structured leadership ensured that the programme remained aligned with operational realities and smoothly integrated into day-to-day activities.
Together, they formed a unified Progress team, guiding the validation effort from initial concept through to full implementation at LelyPharma.
Moving beyond production planning dependent validation
Reflecting on the programme, Paul Tiemeijer points out that one of the defining changes was the deliberate move away from a production-dependent cleaning validation. Traditionally, he explains, validation activities are closely linked to concurrent production campaigns and the availability in the product planning of specific worst-case products. “In an organisation like LelyPharma, with client orders, multiple plants, mobile equipment and a broad product portfolio, that approach inevitably creates delays and operational constraints,” he notes.
By introducing our representative modelling techniques, fully aligned with LelyPharma’s product space and equipment configurations, validation could be executed independently of manufacturing schedules. Cleaning performance was demonstrated under clearly defined, worst case product simulant conditions, without the need for dedicated batches or disruption of production planning. According to Paul, this fundamentally changed both the efficiency and the robustness of the framework. “It allowed us to achieve comprehensive coverage of equipment types and configurations, while still completing the programme within a very acceptable overall lead time of around one and a half years.”
Equally important, he adds, is that the framework naturally supports lifecycle management. New products can be assessed against the existing model, and equipment changes can be incorporated in a controlled way, without having to restart the validation process from scratch.
Building knowledge and capability, not dependency
Thijs Booiman describes the execution phase as intentionally collaborative, with a strong emphasis on capability building at the client, rather than external (consultancy) ownership. Progress worked closely with operators, supervisors and QA specialists throughout the programme, embedding knowledge directly into the organisation. “The objective was never to keep expertise external,” he explains. “From the start, we focused on transferring both the methodology and the underlying rationale. This approach resulted in the promotion of production pharmacist Emilia Sawicki to Subject Matter Expert at LelyPharma. Lelypharma is now fully equipped to independently maintain the validated state, assess new product introductions, and represent the cleaning validation framework during audits and regulatory inspections” .
According to Thijs, this capability transfer is what ensures long-term sustainability for LelyPharma. “The system is not only documented, it is understood,” he says. “That makes it maintainable, defensible and resilient over time.”
A modern Cleaning Validation Policy as backbone
“A key element of the transformation was the development of a modern Cleaning Validation Policy”, says Paul. “This policy provides a clear, CMO tailored, future-oriented structure for acceptance criteria, sampling strategies, rationale development and documentation principles”.
Thijs Booiman explains that the Cleaning Validation Policy was deliberately supported by a fully harmonised documentation structure. Together, Progress and LelyPharma developed a consistent set of protocols and reports, designed to be used across all production trains. “We were very deliberate about using the same logic, terminology and decision-making principles throughout,” he says. “That consistency is what turns separate documents into a coherent system.”
According to Thijs, this harmonisation creates a clear and traceable storyline, from the initial assessment through to final approval. It allows decisions to be followed, explained and defended, both internally and during audits. “When every document speaks the same language, the framework becomes much easier to maintain and much stronger from a compliance perspective,” he concludes.
This harmonisation significantly improved audit readiness and made the validation strategy easier to explain and defend during inspections. The new system has been formally reviewed by both the IGJ and the FDA, and according to LelyPharma CEO Bart Quik, the FDA inspector commented that it was “an outstanding cleaning validation program”, a clear recognition of Progress’s innovative approach, the quality and robustness of the framework.
A system that moves with the business
The real value of the framework lies in its alignment with business operations. Validation runs were planned around natural equipment availability, safeguarding production continuity and avoiding unnecessary downtime. At the same time, the modelling-based structure ensured that cleaning validation coverage remained comprehensive and defensible.
Paul explains that by embedding structured impact assessments into the framework, cleaning validation became part of broader operational and commercial decision-making at LelyPharma. “It is no longer a standalone compliance exercise,” Paul says. “It is a system that now constantly works for the client, supports change, whether that change involves new products, equipment modifications or portfolio decisions.”
The result is a robust, future-proof cleaning validation framework that aligns fully with the realities of modern pharmaceutical contract manufacturing. “It moves with the business,” Paul concludes, “strengthening oversight while enabling agility, rather than constraining it.”
