PROMECO BOEHRINGER INGELHEIM

Quality assurance

Validation and Quality Assurance (for both, liquid and solid forms)

The organization of this area is process-oriented, consequently it drives us to a specialization process by production area. This area is divided in:

Validation and Quality Assurance for the liquid dosage forms plant
Validation and Quality Assurance for the solid dosage forms plant.

This area is responsible for assuring the quality of the different pharmaceutical forms, as well as to perform the inspection of raw and packaging materials, the control of specifications of these materials and other sampling controls performed in the plant.

Quality Assurance has also the responsibility of fulfilling the regulations of the procedures stated by the health agencies of the countries participating in the NAFTA, from which Boehringer Ingelheim Promeco has obtained their certification.

Thanks to Quality Assurance, Boehringer Ingelheim Promeco is the only pharmaceutical company in North America that has homologized the standards of each of these health agencies.

Also, this area has implemented an internal and external audit system (for suppliers) based on the regulations of the three above-mentioned health agencies.

It is currently responsible for auditing suppliers, not only following such regulations, but also collaborating with the Pharmaceutical Industry Suppliers Validation Homologized Group (GHVP-Mexico).

The staff in this section, as well as the Quality Assurance area’s, is highly skilled and has worked in the USA, Canada and several European countries (Germany, Spain, Switzerland, among others).

Quality control

Quality Control has, among others, the following responsibilities:

Analysis of Raw Materials, Container Materials and Finished Products
Stability tests for the different weather zones of the world
Development and validation of analytical methods, mainly for new products.

Also important is the Stability area, which is responsible to perform stability tests under different weather scenarios on products manufactured for local consumption and those for exporting, either to North, Central and South America or to Saudi Arabia and some European countries. For this purpose, it uses high technology in four stability rooms where temperature and humidity are controlled according to the different climatic zones in the world.

A characteristic of the staff in this area is that they all have at least a bachellor’s degree, besides receiving training in countries like the USA, Canada and Germany. The staff is regularly trained in Good Manufacturing Practices (GMPs), Good Laboratory Practices, as well as in instruments and equipment management skills.