Contact English Home Company What we offer Partners Technical area and quality Sustainability Press release QUALITY AS THE OBJECTIVE ADL BioPharma’s success comes from its commitment to the highest quality standards. We understand quality as a continuous work process that leads the company to a shared goal: contributing to our customers’ success and supplying safe and effective products to society. We are just as demanding with our own portfolio of products as we are with developing and manufacturing on contract for third parties. We are experts in our products and processes, and we adapt to our customers’ needs through providing the regulatory advice and technical support they need to guarantee that their projects are successful. HOW WE ACCOMPLISH THIS We have implemented a comprehensive quality-control system (TQM) which is inspected permanently by authorities in Europe (AEMPS) and from the United States (FDA). We comply with both Manufacturing Regulations NFC Q7 (GMP) and Distribution Regulations (GDP), and we enhance them with a rigorous system of our own quality standards. Added to a demanding continuous-training programme and a customer-oriented culture, all these factors mean that ADL BioPharma’s Quality Unit constitutes the cornerstone of the company. STRUCTURE The Quality Unit is divided in three departments: Quality Control, Quality Assurance, and Regulatory Affairs. The Regulatory Department ensures that ADL BioPharma complies with all the regulations that apply to their products and facilities, files in the required documents to register our products with the Health Authorities, and gives customers the support they need. ANALYTICAL CAPACITIES ADL’s full-service laboratories are equipped with a variety of instrumentation to meet the clients testing needs. ADL continues to evaluate and expand our testing capabilities to support our clients growing needs. ADL is prepared to help you build a stability program around the specific requirements of the product, and can manage every aspect of the stability program. CERTIFICATION AND AUTHORIZATION ADL BioPharma is authorized by the health authorities to manufacture active principles, sterile or biological, manufacture drugs for human consumption, and manufacture drugs for veterinary use. FARMA FERMENTATION REGULATORY INSPECTIONS Inspections by US FDA and by the Ministry of Health / AEMPS. AGENCY DATE INSPECTION FDA Aug-19 GMPs AEMPS Oct-18 GMPs FDA-USA Jan-17 GMPs AEMPS Nov-15 AEMPS May-15 Anex, GMPs AEMPS Jan-12 Anex, GMPs AEMPS Nov-11 GMPs USA-FDA Jul-11 GMPs AEMPS Sep-08 GMPs USA-FDA Apr-08 GMPs, Amoxicillin AEMPS Dec-04 GMPs USA-FDA Oct-03 GMPs, Cefalexin USA-FDA Oct-03 GMPs Certifies Organizations Avenida Antibióticos, 59-61 24009 León, Spain Tel +34 987 895 800 Fax +34 987 895 803 © 2021 Antibióticos de León. All rights reserved Legal-notice | Privacy policy | Cookies policy