EU compliance, EU GMP, compliance for sterile preparations, compliance strategy planning, process simulation validation, process cleaning validation, external QA, mock audit, accompanying for inspection
Eye drops, administered directly to the sensitive ocular area, are subject to some of the most stringent sterility requirements in pharmaceutical manufacturing. The production environment, filling process, water system…any minor oversight in these critical areas can become a safety risk. With the tightening of global regulations, especially the implementation of the new EU GMP Annex 1, how to install an aseptic filling line and to ensure sterility of the product has become a major challenge for all eye drop manufacturers. Today, we examine the GMP upgrade case of Similasan AG, a Switzerland company and a global leader in natural eye drops manufacturing, to provide a reference for sterility assurance strategies for eye drop and sterile product manufacturers.
For sterile preparations like eye drops, compliance is not a static "passing an inspection" but a dynamic, lifecycle quality management process integrated into every single drop. When Similasan AG decided to upgrade its core production line for EU GMP Annex 1 compliance, the company faced multiple complex challenges:
New Compliance D ifficulties:
l Extremely High Sterility Assurance Requirements: The products are not terminally sterilized, making aseptic control throughout the entire process a critical task, especially when focusing on the new annex 1 requirements.
l "Online Upgrade" of Older Facilities: Upgrading the aseptic production line and cleanroom areas without interrupting the parallel running manufacturing and market supply was akin to "changing the engine on a flying plane."
l Synchronized Evolution of Systems and Hardware: It required not only equipment modifications but also a comprehensive adaptation of the entire Quality Management System (QMS) with related Standard Operating Procedures (SOPs), and validation processes to meet the new regulations.
l Inspection Pressure: The upgrade needed to pass the strict scrutiny of regulatory authorities in one attempt, within a tight timeframe and with minimal margin for error.
In-Depth Enablement:
Systematically Solving Sterility Compliance Challenges
Facing these challenges, gempex, as a trusted long-term partner of Similasan AG, provided full-cycle support from strategic planning to on-site implementation and execution.
1. Strategic planning and Project Management:
Led by Mr. Ralf Gengenbach, a senior consultant with over 35 years of industry experience, our team translated the principle-based requirements of EU GMP Annex 1 into specific, executable technical and quality solutions, ensuring the project upgrade was on the right track.
2. Breakthroughs in core technologies:
From the User Requirements Specification (URS) to Performance Qualification (PQ), our on-site team was deeply involved in the front line, leading the completion of key tasks such as the technical design for the aseptic filling line retrofit，the design of the surrounding oRABS including cleanrooms from class A to D, the commissioning and qualification of the water for injection system, the Aseptic Process Simulation (APS) verification, up to process and cleaning validation ensuring the compliance of both hardware and processes.
3. Quality system upgrade：
We not only updated documentation but also undertook part of the “external QA activities”, embedding directly into the client's quality system. This included but was not limited to the training of the Similasan staff at each level to ensure no gaps in control during the transition period and solidly integrate the new requirements into daily operations.
4. End-to-End Inspection Guidance:
From mock audits, preparation for inspection, to on-site witnessing and follow-up of inspections, we built client confidence based on our deep understanding of regulations and inspection focal points.
Outcome: Building Future-Oriented Sterile Manufacturing Capabilities
This collaboration achieved decisive success:
l Similasan's eye drop production line now fully meets the high standards of the new EU GMP Annex 1, achieving a qualitative leap in sterility assurance levels.
l Successfully passed relevant official inspections, ensuring continuity of market supply and compliance.
l The company established a sustainable sterile compliance system, laying a solid foundation for long-term development and adapting to future regulatory changes.
Why Can We Help Clients Overcome Sterility Compliance Challenges?
The success of the Similasan AG is not a single case. It stems from gempex and gempex China’s years of deep expertise in the field of sterile drug manufacturing. We understand the unique challenges of different sterile products like eye drops, injectables, and biologics. Possessing a methodology and tools validated repeatedly, we can provide clients with:
l Forward-looking compliance strategy planning
l End-to-end solutions covering facility, process, and quality systems
l Integrated capabilities across interdisciplinary areas, including Computerized System Validation (CSV)
l Flexible and efficient expert resources and personnel support services
We are committed to becoming the most trustworthy compliance partner for pharmaceutical companies, not only helping you "pass inspections" but also empowering you to build a sustainable quality system for sterility and many other aspects, safeguarding patient safety.
If you are facing challenges such as sterile product upgrades, GMP compliance enhancement, or inspection preparation, we welcome you to contact us. With rich practical experience, we look forward to providing you with tailored solutions.
If you want to learn more about GMP solutions, you can visit https://www.gempexchina.com/en/gmp-knowledge. There, you will gain a deeper understanding of GMP services provided by gempex Den Consulting.
If you have specific compliance challenges, please contact us through the following methods.
Hotline: 400 166 2002
Email: info-cn@gempex.com
About Gempex Consulting
Gempex Den Consulting has been deeply engaged in the GMP compliance field for 23 years, dedicated to providing global life science enterprises with compliant, efficient and executable GMP solutions. We assist pharmaceuticals, biotechnology, APIs, chemicals, medical devices, excipients and packaging materials, and cosmetics, among others, in meeting GMP standards and reducing compliance and drug safety risks.
At present, we have over 60 experienced GMP experts. We have executed more than 5,000 projects globally and provided professional services to over 1,000 clients. Our business covers more than 20 countries and we have established long-term cooperative relationships with many well-known pharmaceutical companies.
