­
cropped-Logo_S4BT-_web_2019_White.png
projects

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.

Project

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

Result

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

read about other projects
PROJECT MANAGEMENT
CONSULTING SERVICES ACQUIRED BY THE CLIENT COMPANY
REQUEST MORE INFORMATION
Privacy Policy
Logo_S4BT-_web_2019_White
S4BT_ISO 9001:2015

TOGETHER IS BETTER.

The Company
Quick links
Follow us