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12 September 2013

Process Analytical Technology

Process Analytical Technology (PAT) is a system of planning, analysing and controlling the production processes based on the recognition and optimization of the chemical-physical and engineering dynamics (plants, machinery) which affect the quality and the performances of the product.

The European Medicine Agency in March 2012 passed the new guideline “Process Validation” which, acknowledging ICH Q8, Q9, Q 10, strongly presses the accelerator as far as regards the necessity of developing production processes in the direction of the “Robust Design”.

The same approach is coming also from FDA, which in January 2012 updated its guidelines “Process Validation: General Principles and Practises” specifically quoting the PAT approach as “an instrument which monitoring and acting in real time on production parameters allows a greater control of the processes validation reducing the risk of obtaining an out of specifics product…and for such reason is strongly recommended”, thus explicitly referring to the agreed guidelines ICH Q8, Q9, Q 10.

The fusion of the points of view of both agencies is that the quality of the pharmaceutical products or of the medical devices can’t be tested only on products, but must be designed, planned and combined straight in the productive process.

Moreover, the agencies strongly support the assessment of the so called “space design”, that is a range within which the process parameters have to be changed in real time in order to guarantee the compliance of the final product.

This ratifies the end of locked process parameters which result in the loss of knowledge or of processes which are not entirely under control, since the agencies themselves recommend to vary the process parameters within a specific range in order to toughen up the whole system and obtain results that are always specifics appropriate

The productive process itself must be constantly improved based on the data gathered during the productive steps and the Quality controls.

 

Our consulting services

  • Development of a productive process which constantly supplies the required pharmaceutical formula with the appropriate chemical-physical characteristics.
  • Study of the physical properties of the solid (for example, shape and size of the particles, stability, ease of desiccation, filterability, solubility, dissolution speed etc.)
  • Formulation planning
  • Assessment of the compatibility of the excipients
  • Development of productive strategies of the drug congruent with the properties of the drug itself
  • Support in defining the specifics of the drug products
  • Processing of the final report at the end of the study, including the evaluation of the achieved results.

Our consulting services are ideal to guarantee a consistent quality of the product and reduce the cost of waste and reprocessing.

 

Use cases

  • Regulatory compliance
  • Compliance with the guidelines and subsequently easier registration of the dossiers
  • Easing of the relationships with the drug agencies all over the world through proper and substantiated approaches
  • Decrease of the cycle duration using measurements and controls, in-line (without stopping the sequence) or at-line (taking a sample from the sequence and measuring it on site)
  • Reduction of waste and reprocessing
  • Implemented use of automation to reduce production and analysis time and cost
  • Easing of continuous process with small plants, resulting in energy and material saving and an implemented productive capacity
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