Introduction of a new product on an industrial scale (NPI)

Client: a company that has always been involved in the research, development and marketing of innovative drugs.

Sector: Pharmaceutical

Objective: to develop a replicable process on an industrial system, from which the parameters obtained could be applied in “any” industrial hub.


The client company is a multinational that has always been engaged in the research, development and marketing of innovative drugs, with one of the most modern and cutting edge facilities.

The customer needed to develop a process that could be reproduced on an industrial system, with parameters that could be applied in “any” industrial hub.

Our contribution

The company chose to assign this project to the S4BT NPI team, which deployed its best resources, with extensive knowledge of pharmaceutical production.

The activities carried out by the S4BT professionals are summarised in the following steps:

  • support for the opening of the change request
  • management of experimental materials (Goods receipt support)
  • evaluation of the impact on the cleaning procedure by the introduction of the new product to the
    equipment chain
  • support for the R&D department in the development of the new process on an industrial scale
  • co-ordination and support for production
  • management and deviation assessment activities
  • data collection and evaluation (In process control and analytical data)
  • documentary support (Technology Transfer Strategy, Protocols /Reports, Generic /Procedures /Characterisations, Cleaning Validation /Verification Protocols/Reports)
  • CVI/CV
  • documentary support for production: creation of PPV with process instructions (BOM, Process lines, Yield limits, Pharmaceutical product configuration)
  • support during the product development/characterisation phase for stability studies
  • training of production personnel involved in the introduction of the
    new products


The Client achieved its performance objectives, with the introduction of a new replicable and repeatable process, in compliance with sector regulations and procedures.



An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes


Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes