PHARMACY, VETERINARY AND COSMETICS

Hace más de sesenta años que más de sesenta empresas del sector farmaceútico, veterinario y cosmético confían en nosotros para llevar a cabo sus proyectos de ingeniería y arquitectura.
Gracias a ello, podemos acreditar la realización anual de más de 100 proyectos farmaceúticos de diversa índole.
Para llevar estos proyectos a cabo, disponemos de un equipo de trabajo especializado en proyectos en este ámbito y un know how acumulado a lo largo de los años.

BLUEPRINT AND CONCEPTUAL DESIGN

ESTABLISHING DESIGN CRITERIA:

  • Regulations to be followed
  • Product specifications
  • Production process
  • Estimated needs
  • Machinery for production and associated services
  • Necessary areas (storage, production, offices, laboratories, auxiliary production…)
  • List of rooms and requirements for each type of room
  • Urban parameters
  • Indications of suitable materials
  • Topographic survey and geotechnical study

 

MASTER PLAN, PRELIMINARY STUDY, AUDIT
CONVERTING THE BUSINESS PLAN INTO INFORMATION TO BE USED FOR THE DESIGN:

  • Products to be manufactured (prospects)
  • Volumes
  • Seasonality: distribution and consumption
  • Origin of raw materials and supplies
  • Description of manufacturing processes
  • Storage, dispatch and shipping of the finished product
  • Employees, shifts…
  • Information about the plot and the supply networks available
  • Predicted investment
SCHEMATIC DESIGN
DOCUMENTATION FOR PERMITS AND OFFICIAL PROCEDURES:

  • Project for obtaining works licence
    • Justifying report
    • Plans
    • Justification of regulations
  • Project for obtaining environmental licence
  • Project for fire protection
  • Requests made to supplying companies
  • Necessary permits from local communities and neighbours and neighbours’ associations
  • Budget by section
  • Estimate of planning
FINAL CIVIL WORKS, ARCHITECTURE AND BUILDING SERVICES PROJECTS
DESIGNS FOR TENDERS AND CONSTRUCTION:

  • Construction documentation: details of the construction solutions to be used for each purpose (architecture, structure, HVAC, liquids, electricity, ICT…)
  • A project for each area:
    • Reports
    • Plans and diagrams
    • Calculations
    • Planning
    • Bill of Quantities
  • Tender documentation:
    • Planos y esquemas con detalles constructivos por fases
    • Plans and diagrams with construction details for each phase
      Status of BoQ, with detailed, comparable headings
    • Technical and administrative contract specifications
    • Planning
ENGINEERING OF PROCESSING EQUIPMENT
DESIGN AND INSTALLATION OF PROCESSING EQUIPMENT:

  • Preparation of User Requirements specification (URS).
  • Search for suppliers.
  • Analysis of technical proposals received.
  • Technical comparative report.
  • Analysis and validation of protocols of manufacturers’ tests (FAT and SAT).
  • Supervision of FAT.
  • Supervision of SAT.
TENDERING FOR CIVIL WORKS, ARCHITECTURE AND BUILDING SERVICES
SELECTION OF THE CONTRACTOR AND AWARDING:

  • Decision on the number of lots to tender
  • Support and information for bidders
    • Identical information for all bidders
    • Clarification of doubts
    • Visit to the site
  • Comparison and revision of bids and requests for anomalous prices
  • Second phase of tendering for improvement of offers
  • Comparison of bids
  • Recommendation for awarding
  • Support in the drafting of the contract and its negotiation
CONSTRUCTION MANAGEMENT
QUALITY, COSTS, AND DEADLINES CONTROL ON SITE:

  • Organised management of works so that they are carried out correctly and under the correct conditions
  • Coordination of works in order to meet deadlines and avoid interferences
  • Approval of the documentation presented by the contractor
  • Revision and validation of the certificates before they are sent to the Client
  • Quality control of materials and execution
  • Control of costs and planning
  • Coordination of the delivery of the processing equipment
  • Management of the creation of the as-built documentation, prepared by the contractor.
  • Presentation of the final documentation
LAUNCH AND COMMISSIONING
SUPPORT AT THE BEGINNING OF THE OPERATIONS:

  • Creation of the documentation for FOL or similar procedures
  • Support with the starting of the machinery
  • Support during the testing
  • Creation of a data bank of the project (certificates, manuals,
  • recommendations for use and maintenance, plans…)
LICENCES AND PERMITS
OBTAINING OF THE DOCUMENTATION TO GUARANTEE THE LEGALITY OF THE ACTIVITY:

  • Guarantee that the licencing rules and regulations are met
  • Require certificates that show compliance with certain specifications (legal, quality, etc.)
  • Guarantee the provision of manuals and staff training
  • Provision of as-built documentation
  • Maintenance plan
VALIDATIONS AND QUALIFICATIONS
CUMPLIMIENTO DE GMP /GLP FARMACÉUTICAS:

  • Masterplan of validaciones (MV)
  • Cualificación de la documentación (DQ)
  • Cualificación de la instalación (IQ)
  • Cualificación de la operación (OQ)
  • Cualificación del rendimiento (PQ)
  • Calibración

PHARMACEUTICAL CONSULTANCY

AUDIT

UNDERSTAND IN ORDER TO FORESEE.
MEASURE IN ORDER TO IMPROVE.

  • General audit plan
  • One-off or periodical audit of specific areas or phases
  • Audit and certification of suppliers
  • Audit of activities subcontracted to third parties
  • Audit of management systems
CONCEPTUAL DESIGN

OBTAINING THE IMAGE:

  • Conceptual design of production (vertical, horizontal)
  • Process diagrams
  • Flows of materials, people and products
  • Planning of activities
  • Estimation of costs and deadlines
  • GMP and legal requirements
COMPLIANCE WITH REGULATIONS

COMPLIANCE:

  • Evaluation of the level of compliance with the current regulations
  • Changes and adaptations to comply with the regulations
  • Preparation of the documentation for official type approval
TELECOMMUNICATIONS AND INFORMATION SYSTEMS

CORRECT USE OF ICT:

  • Analysis and design of information systems
  • PM of ICT systems
  • Programming services
  • Telecommunications consultancy
  • Systems audits
  • Management of systems for the development of information systems
SYSTEMS FOR MANAGEMENT OF QUALITY AND THE ENVIRONMENT

RESPONSIBLE MANAGEMENT:

  • Assessment of level of compliance with regulations ISO 9001, ISO 17025, GMP, GLP…
  • Evaluation of environmental risks
  • Integration of the requirements laid out in ISO 9001, ISO 14001, and EMAS into the management system
  • Creation of manuals for quality, the environment and documentation control systems
TRAINING

LEARNING TO OPERATE:

  • General knowledge of regulations
  • Familiarisation with GMP, GLP, hygiene regulations, regulations specific to products, storage, production, maintenance…
  • Training in quality and environmental systems
  • Training in the development of documentation systems
  • ICT training
Central Barcelona
Via Augusta, 4, 08006 Barcelona
Teléfono: 932 17 56 54

Delegación Madrid
Ribera de Loira, 46 · 28042 Madrid
Teléfono: 918 893 745