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Client: a company that has always been involved in the research, development and marketing of innovative drugs.
Sector: Pharmaceutical
Objective: management of technology transfer activities for the manufacturing process of an oral solid product from the Issy-les-Moulineaux Cedex plant in France to Egypt,
The client company, a pharmaceutical multinational, has always been involved in the research,
development and marketing of innovative drugs with one of the most modern and cutting-edge facilities.
The transfer of products from one country to another plays a strategic role for the Group, requiring expert management of the operation.
Developing and implementing an efficientTechnology Transfer plan, in accordance with stringent regulatory requirements, was therefore the main challenge of the S4BT Technology Transfer Team assigned to this sensitive task.
S4BT provided its best consultants, all with significant national and international experience, who handled:
Preliminary documentation: issuance of the Technology Transfer Strategy (TTS), Analytical Method Transfer: planning and organisation, support for obtaining samples and standards, and review of the protocol and report
Site and manufacturing preparation:
Quality/GMP/RA assessment:
conformity check on raw materials and products
Planning and Management:
The client company achieved its stated goals, overcoming the typical international transfer problems, such as communication difficulties, the alignment of documents, regulatory differences and differences in culture, in compliance with the regulatory requirements of the process.
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Pharmaceutical Company
An international pharmaceutical contract manufacturer specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.
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TOGETHER IS BETTER.
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
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