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12 September 2013

Formulation Development

In studies for the realization of a pharmaceutical form, different formulation aspects are considered, related both to the drug-excipient/s compatibility and to the most adequate preparation procedure to ensure and maintain the physical and chemical properties which characterize the final dosage form.

Through the implementation of the reference standards and according to the industrialization of the production processes, experimental studies are performed in order to register brand-name and/or generic drugs and to their industrialization.

The whole process is constantly improved according to the data gradually gathered during the production routine. Scraps, waste and the performance in general are improved eliminating the reprocessing due to OOS (out of specifications – analytical results out of specifications).

 

Our consulting services

  • Development, industrialization, optimization and validation of pharmaceutical processes according to reference standards (DOE, FMEA, QbD, PAT; ICH q8/ q9/ q10, STM, ISO)*, with ongoing reports
  • Drafting of procedures for  Prospect (before the marketing of the product), Concurrent (during ordinary production) and Retrospective (regarding processes that have been consolidated and already operative for a long time) Validation, also in support of DMF (Draft Master File)
  • Protocols to maintain the validation status
  • Process Validation Report (Report on data gathered during the validation process)
  • Medium-term reports (Interim Reports)
  • Recognition of the CQA (Critical Quality Aspects)
  • QRM (Quality Risk Management)
  • Bibliographic research aimed at the correct planning of the scientific research
  • Patentability assessment
  • Interpretation of analytical results
  • Technical-scientific assessment of the utilized materials, excipients and polymers. It is possible to perform the characterization of the materials by means of our laboratories.

Our consulting services are ideal for the optimization of the formulation and of the production process of the drug complying with the GMP regulation (Good Manufacturing Practices) and to  transfer scientific knowledge to the industrial production.

 

Use cases

  • Formulation of specimens for investigative (ICS) and stability clinical studies
  • Before starting the optimization of the properties of the product or of the process
  • In the logic and systematic research of the causes of a problem, in order to solve the problem itself and to make the product, or the process, affected by it, operative again and to prevent further malfunctioning (Productive Troubleshooting)
  • To evaluate the effectiveness of the employed equipments
  • To facilitate the Technological transfer (the transfer from one site to another)
  • To project the industrial scale-up (the transfer of a plant from a down scaled level to the industrial one)
  • To project the industrial scale-down (the transfer of a plant from the industrial level to a down scaled one)
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