Quality
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.
Quality Assurance
Led by our Technical Director (QP), our Quality Assurance 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 also qualified to develop and validate new analytical methods.
Regulatory Department
Our team participates in the development of new products and is responsible for drafting and filling in 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 file changes 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.
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.
- Liquid chromatografhy (HPLC).
- Gas chromatografhy.
- Thin-layer chromatography (TLC).
- UV/VIS.
- IR identification.
- Particle size determination.
- Moisture,Karl Fischer.
- Physico-Chemical evaluations.
- Headspace.
- Density, pH, osmolarity.
- Bioburden.
- Endotoxin testing.
- Sterility.
- Microbial identification (MALDI-TOF).
- Specific microorganisms quatification through Maldi-Tof system.
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.
- Stability Protocol development.
- Stability conditions available in validated stability chambers.
- Stbility time point management and sampling.
- Final reporting.
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
Ministry of Health, Consumer Affairs and Social Welfare: Certificate of GMP compliance of Manufacturer.
U.S. Food and Drug Administration: Establishment Installation Report (EIR).
Authorization: Manufacturer of active principles, sterile or biological; Laboratory Authorization Number 6594E.
Fermentation
NQA Certifying Company: GMP recommended by the CODEX Alimentarius Commission.
U.S. Food and Drug Administration: Registration food facilities.
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 |
