EXCELLENCE ON THE ENTIRE LINE.

Seratec operates a plant in a high quality environment, declared acceptable by the FDA in 2003 and by the ANSM (French Agency for Europe) in 2007:

Each manufacturing site must obtain a manufacturing authorization before committing to any activities. It is then subjected to periodic and rigorous inspections by international health services. If the products are registered in the US, this is done by the world’s strictest agency, the Food and Drug Administration (FDA). If the products are marketed in Europe, the European Medicines Agency (EMA) is represented in France by the ANSM, one of the most stringent agencies in the EC. In France an obligation to request authorization and declare active substance manufacturing activities is required pursuant to Articles L. and R. 5138 of the Code of Public Health (CSP).

Added to this is a pre or post approval GMP inspection obligation, so that if the authorities believe that the quality, safety and efficacy of the products manufactured are compromised, the authorization is withdrawn and production is immediately stopped. This inspection facility is also open to our Customers in the pharmaceutical industry.

Facility design is thus a key step in obtaining an authorization (pre-approval inspection, compliance of facilities and GMP certificates). The plant is commissioned after verifying compliance of its construction with the design criteria (qualifying stages of the plant). Verification of the compliance of the facilities for their intended use is then applied to the manufactured products (stages of validation of manufacturing procedures of the qualified products).

A facility’s compliance starts at the design phase and is not limited to its operation. Its verification includes processes and critical points that range from the design of the facility to its commissioning.

This long and rigorous work: engineering of the facility, equipment and systems qualifications for approval of the facility, and moreover, qualification of the active ingredient and validation of the procedures and methods for the chemical and pharmaceutical documentation of the API, are required for a marketing authorization application of the final medicinal product to be successful. [Full information on the life of an API]

At present, the Seratec plant for manufacturing active pharmaceutical ingredients has three workshops:

Production (with capacities of 200 liters to 1 m3)

Pilot (100 to 200 liters)

Kg Lab (60 to 100 liters)

Other workshops are being designed with our engineering team.

Each workshop has:

- A dedicated drying room under controlled atmosphere (class C)

- Dedicated adjacent utilities

So that our workshops have a material flow, staff flow and equipment flow.

Taking into account legal and regulatory requirements, the flow analysis and segregation procedures in the design of our workshops has made it possible to develop modern concepts anticipating the requirements of pharmaceutical chemistry.

The entire plant works, moreover, according to international rules on protecting the environment. Environmental impact analyses are conducted for each of our manufactured active ingredients and processed materials.

Our facility design systematically analyzed and anticipated requirements concerning the environment, safety, and the necessary safeguards for the continuous improvement of our facilities as a pledge of guarantee of our workshops: for our customers, for the patients, for the authorities and for our staff.