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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 into two departments, Quality Guarantee and Quality Control, which are supported by the company’s R&D Department. There is also a Regulations Department to ensure that ADL BioPharma complies with all the regulations that apply to their products and facilities, files the required documents to register their products with the Health Authorities, and gives customers the support they need.

Quality Guarantee

  • Led by our Technical Director (QP), our Quality Guarantee team makes sure that every stage of the production complies with all the applicable regulations and policies, through the implementation and continuous improvement of the right procedures.
  • This is reflected in the success of both internal and client audits and the inspections carried out by the health authorities.

Quality Control

The department of Quality Control, with a team divided into 3 areas (chemical, microbiological and chromatographic analyses), provides the technical and scientific support to control every stage of the production process and stability studies. The department is qualified to develop and validate new analytical methods as well.

Regulations Department

Our team participates in the development of new products and is responsible for drafting and filing the documentation required to comply with the Quality Module (module 3 of the CTD-ICH) with customers and/or health authorities.

In addition, the team is in charge of updating documents, managing the necessary changes in the file for the entire life-cycle of the product according to the regulations in force worldwide, and advising other ADL BioPharma departments as well as clients.

Certification and authorizations

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.

  • GMP Certification:​ GMP Certification from the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) and ratified by the FDA-USA (EIR).
  • Authorization:​ Manufacturer of active principles, sterile or biological; Laboratory Authorization Number 6594E.

Regulatory inspections

Inspections by US FDA and by the Ministry of Health / AEMPS.

Agency Date Inspection
FDA-USA Jan-17 GMPs
AEMPS Nov-15 GMPs
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