Manufacturing processes have usually more than one requirement to comply with:
They are expected
- to produce the desired dosage form in a specified quality
- to be economic (e.g. with regard to costs for procurement, operation, maintenance and repair of equipment)
- to be suitable for being handled and operated by the personell available
- to provide robust processes resulting in a product in compliance with specifications even when process parameters are applied with slight variations (Design Space)
- to be validatable
Design of manufacturing processes is thus always directly connected to formulation development. Only combined know-how of formulation development and pharmaceutical technology is the key for development success.
We are here and ready for supporting you in this task.
Effectivity (and not only efficiency) of pharmaceutical development connected with technological know-how can be gained only once the matching organisational environment is given.
It has proved to set up a catalogue of functions needed for a successful pharmaceutical development and align the organisation accordingly.
Usually there is a certain standardised sequence of activities in the business process of pharmaceutical development, fairly independent from a particular dosage form and thus suitable for standardisation and repeatable. Example: no dosage form without API, no stability without dosage form and primary packaging etc.
As a specified sequence of described single steps / unit operations (input = prerequisite for start of this step, output = expected result, necessary ressources etc.) the entire process is becoming calculable with regard to time, ressources and money needed.
A strongly simplified example: blending of API and excipient -->
Input = starting materials (API and excipients),
Output = blend,
Ressource = blender + operator
Such a stepwise procedure enables reliable schedules and deadlines - an important prerequisite for interdisciplinary drug development.
We provide support in development and improvement of respective business processes and related organisational changes (if necessary) !