Compliance & regulatory track record
Code of Business Conduct & Ethics
Farmabios S.p.A. is committed to ethical behavior and appropriate business conduct in each and every interaction. Our employees are personally accountable for upholding our Code of Business Conduct and Ethics every day.
Quality
At Farmabios, quality is much more than a set of rules – it’s a mindset. We first develop rigorous quality systems and programs at the corporate level and roll them out at the site levels. Quality systems are continually monitored and assessed for effectiveness and improvements. This approach ensures the consistently high quality of our products at all locations.
Our experience in quality assurance spans decades, enabling us to consistently meet current GMP requirements. We have a track record of successful GMP inspections conducted by many GMP authorities, listed under the Production Site. The corresponding GMP certificates and written confirmations are available upon request.
Regulatory Affairs
For all commercially manufactured active pharmaceutical ingredients Farmabios holds Drug Master Files (DMFs) and/or Certificates of Conformity with the European Pharmacopeia (CEPs) with health authorities worldwide.
Farmabios employs a team of highly trained regulatory experts who provide the full spectrum of regulatory support to customers throughout the process.
- We work closely with customers, maintaining and updating the registration dossiers throughout the life-cycle of a product.
- During the development process of new products, relevant data for Chemistry, Manufacturing & Control (CMC) are compiled and prepared for filing.
- Customers are supported throughout their interactions with regulatory agencies, ensuring their final products are registered efficiently and quickly.
Strong regulatory history
- AIFA (Italy) & FDA (US), regular inspection every 2 years
- KFDA (Korea) and PMDA (Japan), regular on-paper inspection every 5 years
- The company is ISO 9001, ISO 14001, and ISO 45001 certified
- More than forty customer on-site audits per year
REACH
Farmabios ensures the supply chain of our products is globally compliant with the relevant chemical substance control legislation.
Farmabios supports the European REACH legislation which came fully into effect in 2018. The legislation holds importers and manufacturers of chemicals accountable for the safety and environmental impact of their products.
Farmabios ensures that all raw materials used in its synthetic routes, isolated intermediates, and final products, whether manufactured in European Union or imported from subsidiaries outside of the European Union, are compliant with REACH.
We work closely with suppliers to ensure that our supply chain is stable and completely REACH-compliant. By continuously assessing our filing strategy, we can ensure the market supply of our products.
Safety, Health & Environment (SHE)
Farmabios is focused on the health and safety of our employees, customers, and local communities. Our commitment covers the following:
- We adhere to the highest safety standards to ensure the health and safety of our employees, neighbors, customers, and consumers.
- We follow safety-first policies to prevent accidents and injuries.
- We liaise proactively with local communities and local councils to maintain good relationships.
- We provide extensive safety training programs for employees and contractors.
Farmabios has programs for reducing emissions and employing environmentally friendly initiatives. We promote strict environmental compliance everywhere we operate and we are fully committed to continuously improving our environmental performance.
Ecovadis
In 2023, Farmabios S.p.A. site achieved an outstanding ranking of 70/100 for each pillar assessed by EcoVadis: Environmental, Labor & Human Rights, Ethics and Sustainable Procurement. This ranks the Gropello Cairoli site among the top 6% of companies evaluated by EcoVadis.
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