Making GMP Annex 1 Work in Practice

Reinraumumgebung mit robocell-Abfüllanlage von groninger, bedient durch geschultes Personal in Schutzkleidung, für aseptische Produktion in der Pharmaindustrie

Home / Pharma / Aseptic filling machines / Annex 1

The Contamination Control Strategy as a New Foundation for Sterile Processes

Annex 1 is far more than a set of rules. It is a strategic approach to the holistic control of microbiological and particulate risks. The current EU GMP Annex 1 requires a comprehensive, documented Contamination Control Strategy (CCS) that considers all process steps in an integrated manner. For manufacturers, this means increasing requirements in terms of technology, risk-based design and evidence generation.

groninger develops fill & finish solutions specifically aligned with these requirements and actively supports your CCS. From hygienic design and well-conceived risk-based process management through to qualification, we create the basis for safe, efficient and Annex 1-compliant production processes. We also work in close collaboration with leading industry bodies, actively contribute to the implementation of requirements and participate in best practice content to provide optimum support to the pharmaceutical manufacturing industry.

Request an Annex 1 Assessment now

What does Annex 1 require?

With EU GMP Annex 1, the Contamination Control Strategy (CCS) moves to the centre of sterile manufacturing and obliges manufacturers to provide complete and holistic documentation of all processes. PDA Technical Report No. 90 makes it clear that equipment is also a central component of the CCS.

This includes in particular:

hygienic design
decontamination concepts
qualification and evidence generation

The selection of machinery therefore simultaneously represents the selection of an active CCS contribution. groninger develops machines that are specifically designed to function as an integral component of your Contamination Control Strategy. We consistently pursue a risk-based approach. Grounded in a strong scientific understanding of the process, we critically assess all relevant factors and translate them into robust design and implementation concepts.

Diagram of a CCS framework highlighting governance, control monitoring, validation and contamination controls with foundational quality and risk management elements.

Challenges

Where Annex 1 becomes challenging in practice

While Annex 1 sets a clear regulatory framework, FDA and European inspections continue to highlight recurring gaps in real-world implementation.

Common observations include:

Lack of a defined and validated First Air concept
Presence of non-sterile components in critical zones (e.g., exposed product areas)
Manual installation of sterile components within isolators
Weak or insufficient transfer concepts for critical materials (e.g., sorting bowls)

Our Approach

Systematically minimizing risks

Annex 1 has accompanied groninger since its publication. Our machine development follows a structured, risk-based engineering approach. The objective is to accelerate validation processes, successfully pass audits and ensure robust sterile processes.

groninger addresses these challenges early and with clear focus. Through optimized system design, purpose-built tools, and well-defined, documented processes, potential risks are systematically reduced - already during development and implementation.

Before a groninger machine is developed, it undergoes a structured Annex 1 design assessment. All relevant components are systematically reviewed, evaluated and optimized. The objective is to identify potential contamination risks at an early stage and to reduce them on a technically sound, scientific and data-driven basis.

Process diagram for Annex 1 contamination control showing classify, assess and act steps including criteria such as cleanability, sterilizability and First Air

robocell: Annex 1-compliant automation

With robocell, groninger consistently implements key Annex 1 requirements: the minimization of manual interventions through intelligent automation.

Your advantages:

Automated aseptic processes instead of glove interventions
Optimized First Air management over open containers
Full isolator integration
Significantly reduced risk due to human intervention

Discover robocell

Annex 1 requires a fundamental and systematic re-evaluation of existing processes. Working closely with our customers and leading industry bodies such as the Parenteral Drug Association (PDA), we develop robust, risk-based and scientifically justified approaches to ensure compliant implementation of these requirements.

Julian Petersen

Head of Business Development, groninger & co. GmbH