Compliance
Code of Business Conduct & Ethics
PharmaZell Group is committed to ethical behavior and appropriate business conduct in each and every interaction. Employees are personally accountable for upholding our Code of Business Conduct and Ethics every day.
Code of Corporate Social Responsibilities
PharmaZell Group is fully committed to operating our business in sustainable and responsible ways to ensure the well-being of our employees and to protect the environment. Code of Corporate Social Responsibility
Quality
Quality is much more than a set of rules at PharmaZell Group – 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 long track record of successful GMP inspections, conducted by many authorities (see list under Production Sites). The corresponding GMP certificates and written confirmations are available upon request.
Regulatory Affairs
For all commercially manufactured active pharmaceutical ingredients PharmaZell Group holds Drug Master Files (DMFs) and/or Certificates of Conformity with the European Pharmacopeia (CEPs) with health authorities worldwide.
PharmaZell Group 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.
Active PharmaZell Group registrations worldwide:
REACH
PharmaZell Group ensures that the supply chain of our products is globally compliant with the relevant chemical substance control legislation.
The PharmaZell Group 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.
PharmaZell Group 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)
The PharmaZell Group 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 a collaborative relationship.
- We provide extensive safety training programs for employees and contractors.
PharmaZell Group 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. We are committed to using the most eco-friendly synthetic routes and processes. These include:
- Green Chemistry initiatives
- Advanced wastewater treatment methods and facilities
- Safe waste handling and management
- REACH compliant processes
