Quality Never Stops
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Go to sectionWith our exciting and engaging work, we want to bring the widest possible awareness about this paramount value to the world of phytochemistry.
For us, quality is not a special side project. It is an inclination, a daily practice, a constant, an unavoidable requirement for products, processes, technologies, services and solutions.
We always strive to dissect, analyze and constantly evolve our quality system, ensuring even greater fairness in the system itself.
Indena’s Commitment to Excellence
Quality is at the very core of our business.
At Indena, we do not just meet quality standards—we set them.
While API production follows established pharmaceutical regulations, our ingredients for medical devices, nutraceuticals, and cosmetics often exceed mandatory requirements, demonstrating our unwavering commitment to delivering superior quality across all product categories.
The definition of quality extends beyond compliance.
A high-quality product is expected to deliver the intended benefits with reliability, consistency, and safety.
This philosophy guides our quality system across all manufacturing processes, ensuring that every product—from medical device ingredients to nutraceuticals and cosmetic ingredients—meets and often surpasses the applicable regulatory standards.
Indena's Expertise
Indena plays a key role in the production and control of products for various global markets, including:
- Ingredients for medical devices
- Nutraceuticals
- Cosmetic ingredients
- Excipients for pharmaceutical and other uses
- APIs for pharmaceutical use
Our commitment to quality ensures that each product category meets stringent safety and performance criteria.
While APIs comply with strict pharmaceutical regulations, our ingredients for nutraceuticals, medical devices, and cosmetics adhere to even higher standards than required by law, reflecting our dedication to excellence.
While APIs are subject to stringent regulatory requirements set by global pharmaceutical authorities, Indena’s quality commitment does not stop there.
We implement full traceability from plant cultivation to final product, ensuring our APIs meet and exceed all harmonized cGMP guidelines and regulatory expectations.
Ingredients used in medical devices must comply with strict safety regulations based on a risk-based classification system.
Our production process guarantees:
- Full traceability from raw materials to final product;
- Compliance with global medical device regulations;
- Customizable quality agreements that meet or exceed pharmaceutical standards for high-risk applications;
- Special considerations for injectable and implantable devices, where quality standards match or exceed pharmaceutical-grade requirements.
Nutraceutical ingredients must comply with international food legislation, including:
- The US Food Safety Modernization Act (FSMA) for the safety of finished nutraceuticals;
EU Food Safety Management Systems (FSMS), which integrate Good Health Practices (GHP) and Good Manufacturing Practices (GMP);
Rigorous Hazard Analysis and Critical Control Points (HACCP) protocols,
Our approach ensures that nutraceuticals not only meet but exceed food safety standards, providing consumers with scientifically validated, high-quality products.
Our excipients are designed to exceed conventional pharmaceutical standards. Depending on their intended use (parenteral, oral, etc.), our excipients follow cGMP guidelines and undergo rigorous quality control processes to ensure safety, purity, and functionality in various applications.
Cosmetic ingredients require an extraordinary level of quality to ensure safety and efficacy.
At Indena, we apply the same rigorous principles used in pharmaceutical manufacturing, ensuring:
- Purity and safety exceeding regulatory minimums;
- Scientifically backed formulations;
- Traceability and sustainable sourcing.
Meeting and exceeding regional and global requirements.
Ensuring product efficacy throughout its lifespan.
Maintaining consistency across batches.
Preventing toxic contaminants from entering the supply chain.
Reducing failure rates and ensuring consistency.
Guaranteeing product longevity.
Ensuring a stable and efficient supply chain.
Enhancing products with innovative characteristics.
Providing customer support and technical expertise.
Building trust through transparent and superior quality assurance.
Our mindful innovation
Indena embraces innovation in quality control, shifting from a traditional product testing approach to a proactive Quality by Design (QbD) strategy. This approach ensures defects are prevented rather than detected, integrating quality into every stage of production.
Indena embraces innovation in quality control, shifting from a traditional product testing approach to a proactive Quality by Design (QbD) strategy. This approach ensures defects are prevented rather than detected, integrating quality into every stage of production.
As part of this ongoing transformation, Indena has successfully implemented the TrackWise Quality Management System (QMS) across its global network by the end of 2024.
This strategic milestone enhances the management of key quality processes—such as Change Control, Deviations, CAPA, Audits, Supplier Management, OOS, Returns, and Complaints—while strengthening data integrity and harmonization across all sites.
Now fully operational at our facilities in Italy, France, and India, the system supports our commitment to regulatory compliance, operational excellence, and continuous improvement.
With TrackWise, Indena further empowers its teams with greater transparency and efficiency, reinforcing a proactive, integrated approach to quality on a global scale.
Indena successfully faced a market need for regulation by investing in technology: following a scandal in the supplement industry, the American market decided to develop genomic identification tests for natural products.
This challenge led to an innovative intuition: genomic analysis as an easy tool to directly verify a plant’s authenticity. Today, Indena identifies every plant coming into the company using genomic technology.
BOTANICAL DNA ID
There is no check for origin in the DNA genomic data deposited in public databases (e.g. Genbank): the system lacks “reference” DNA profiles deriving from the analysis of plant samples of known, certified origin such as herbariums and taxonomically identified specimens.Therefore, it is of paramount importance to have certified, pure samples in order to derive reference DNA sequences. Building a solid genomic database is essential for us to produce species-specific methods, which can distinguish one particular plant from another and thus from adulterants.
INDENA’S APPROACH TO GENOMIC IDENTIFICATION
DNA barcoding is orthogonal: a single technique may not be enough. A strong botanical background to structure DNA methodologies. Leverage the ability to use the whole range of available DNA techniques. Use authenticated plant material to develop highly reliable DNA tests. Carefully define where, when and how to collect the reference species to be used as “certified” controls to validate DNA methods. Develop the ability to identify unknown species.
INDENA GENETICALLY CERTIFIES THE PLANTS IT USES
In consideration of the importance of plant DNA testing within the Indena quality system, and in order to communicate such analyses in a way that is more immediate and easy to use by clients, Indena developed the specific IN-DNA logo
First application: MIRTOSELECT® - Bilberry Extract
The key to our method's success is that the amplified region must be univocal for Vaccinium myrtillus.
Indena holds preferential access to breakthrough technology
for the on-site identification of botanical species, exclusively for the food supplement ingredient industry.
The device that makes this possible is the bCUBE®*, made by Hyris Ltd.
Through an exclusive agreement, and drawing from the solid Indena database of references Indena has compiled over decades, DNA fingerprint analysis on plant samples can be carried out
in the field, even by unskilled personnel.
*bCUBE® is a registered trademark of Hyris Ltd
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