PROJECTS

Stability and Degradation Studies

Client: The client company is one of the leading chemical-pharmaceutical companies in the world,
engaged for decades in the development of new medicines and in the introduction of cutting-edge
technologies and innovative ways of managing health.

Sector: chemical-pharmaceutical

Objective: to carry out stress testing and stability studies on certain formulations (in order to obtain available data on the onset of impurities and on the setting of specification limits).

Our contribution

The client chose to cooperate with the S4BT Laboratory consultants, who focused on:

  • exposure of the samples to the various degrading agents obtained
  • drafting of related protocols
  • execution of tests on a periodic basis related to degradation
  • preparation of the final report with evaluation of the results

Result

The project allowed the client to further strengthen a production approach oriented towards quality and continuous improvement, in compliance with ICH guidelines and internal policies.

The study has proved effective and invaluable and has been used in the client’s facilities all over the world.

consulting services acquired by the client company
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Project

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Digitised processes
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Projects completed in 2019
CLIENT

Pharmaceutical Company

An international pharmaceutical organisation specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

Home office

Digital Company

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Home office

Petshop Company

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PROBLEM

Conditioner Company

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retail office

Card Rental

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Home office

Expedition Company

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COMPLAINTS

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

AUDIT

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