n order to respond to the needs of design, implementation and validation of pharmaceutical and cosmetics laboratories under the GMP (Good Manufacturing Practice) standards, CPQ Ingenieros has created the CPQ Pharma division, with the objective of developing these projects from the whole, including our extensive and proven experience in pharmaceutical design and incorporating the disciplines of civil engineering to industrial construction, architecture of sanitary clean rooms, specific services for these plants (purified water, treatment of air for totally clean rooms, dust collection,…) and the generation of a global validation document of the entire installation, from civil engineering to global services.
This allows us to have a unitary and validated documentation for any laboratory project, which simplifies official inspections and ensures success in the subsequent revalidations.
Additionally, we have reliable contacts with leading companies who are dedicated to the specific facilities necessary for this type of projects, having successfully worked with most of the leading brands in laboratories throughout the Iberian Peninsula
Ello permite disponer de una documentación unitaria y validada para el Proyecto de Laboratorio, que simplifica las inspecciones oficiales y garantiza el éxito en las revalidaciones posteriores.
Asimismo, disponemos de contactos fiables con las principales empresas que se dedican a las instalaciones específicas necesarias para este tipo de proyectos, habiendo trabajado satisfactoriamente con la mayor parte de las primeras marcas de Laboratorios en toda la geografía peninsular.
Our services are often developed through the following consecutive phases:
- Assistance to the owners of the property in writing, on the one hand the user requirements and on the other hand, the Validation Master Plan (VMP).
- Assistance to the owners of the property in the creation of the Validation Committee.
- Management and drafting of the necessary documents for the municipal, regional and federal authorizations.
- Drafting of the documentation of project in DQ (Design Qualification) format.
- Generation of any validation documentation, both regarding the civil works as well as for the clean room data sheets.
- Processing facilities: reactors, electrical and control installations, mechanical installations, etc.
- Service installations: air conditioning, distribution of solvents and reagents, sanitation, nitrogen, waste treatment, etc.
- Specific installations: treatment of air, purified water, breathable air, clean steam, etc.
- Laboratory equipments.
- Assistance to the owners of the property on FAT (Factory Acceptance Test) testing and SAT (Site Acceptance Test) of the equipment and important facilities subject to validation reviews.
- Along with the owners of the property, the creation of documents for IQ (Installation Qualification).
- Assistance to the owners of the property in the process of Plant Start-Up.
- Assistance to the owners of the property in the creation of the PQ (Performance Qualification) documentation.
The outline of our activities allows our customers to have a single contact to manage all aspects of the design of such type of installations in order to coordinate their critical aspects.