Conceptual Design& Turn-Key Project 

Complete guidance and mentor Pharma industries and professionals on all their requirements and projects. We also offer turnkey project execution, and project management .



The Conceptual Design is based on the Business Plan guidelines which define in detail which products to manufacture, and lots and volumes and pharmaceutical processes that will be used. Equipment, machinery and technology, as well as all auxiliary facilities are identified and sized. Required buildings and rooms as well as the interactions between them are planned to facilitate the flow of production. Finally a project timetable is established and determined and the costs associated with the project are detailed.

Valor can perform all the tasks that a conceptual design must include for the project to comply with customer expectations in terms of the end goal for which it is proposed, as well as cost and implementation schedule. Among other activities it would include:

         1.Product Definition  
         2.Definition of production and analytical processes  
         3.Selection of technologies and equipment  
         4.Definition of volumes and lots sizes  
         5.Definition of product requirements  
         6.Definition and sizing of services  
         7.Proposed Layout  
         8.Making pharmaceutical plans ( Zooning, pressures, flows of materials and people, equipment layout)  
         9.Preliminary verification of the adequacy of the project with regulatory agencies  
         10.Project Timeline  
         11.Investment proposal or BOQ


  • conceptual design consultancy






Valor can coordinate and perform all necessary operations from the definition of user requirements to the qualification of all facilities and equipment, among other activities, including:                                                                

  •  User requirements definition (URSs)
  •  Master Plan Validation
  •  Drafting and implementation protocols DQ, IQ, OQ and PQ of equipment and facilities
  •  FAT and SAT performed by suppliers
  •  Drafting the the site master file
  •  Support for EMA or FDA approval


  • quality plans consultancy



Once the typology of the product is defined, the selection of the technology is critical for each phase of the productive process, as the correct selection of equipment, plant sizing and finally the correct definition of the processes. Valor as part of the project, can collaborate with the client from the selection of equipment both manufacturing and analytical, to start up, approval and training in a productive area, as well as writing all regulatory documentation (Module 3) for inclusion in a dossier of records .


Finally  Valor can coordinate in a global way all the needed requirements (facilities, equipment, support documentation, transfer protocols and regulatory changes) for the transfer of a product from one plant to another. In summary, it can support     all these activities:

    •  Selecting the most appropriate technology for all processes both manufacturing and analytical
    •  Comparison of technical equipment available on the market for both manufacturing and analytical processes
    •  Making FAT and SAT of the selected equipment
    •  Accomplishment of protocols DQ, IQ, OQ, PQ of the selected equipment
    •  Accomplishment of SOPs for equipment (Operation, cleaning and maintenance)
    •  Calibration Plans
    •  Definition and theoretical training on the main parameters in the process
    •  Training in the use of equipment both process and analytical ones
    •  Support at the start of equipment during commissioning, scaled or validation process
    •  Support for transfer of products from one manufacturing plant to another
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System Document preparation& Review:
Valor can assist in the preparation of SOPs that support the ongoing activities of our clients in addition to providing guidance for the implementation or revision of SOPs to ensure compliance with regulatory requirements. We can also provide standard templates of SOPs, forms and checklists developed in compliance with ICH guidelines, FDA CFRs, EMA directives, Health Canada regulations and industry standards,  We can provide this review as part of an ongoing Quality Assurance oversight mandate or on an ad-hoc basis.

Preparing for Certification:
Valor experts in ISO certification provides a complete implementation service, taking customers from initial assessment to certification.

Vendor Auditing:
Valor has extensive experience in auditing  vendors against regulatory requirements. We have undertaken many different audits over the years for many different systems in all areas of GxP. We focus on ensuring that systems are adequately documented and validated. We also evaluate whether systems are fit for their intended use and whether they are a good fit for our clients

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