CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.2 Pharmaceutical Development

Drug Product

● Manufacturing process development – selection and optimization of the process. CPPs during development and in line with P.3.4! ● Choice of sterilization method – terminal sterilization at Ph. Eur. conditions are the first choice – 5.1.1. Methods of preparation of sterile products – reference conditions ✓ Decision trees Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container – the highest possible level of sterility assurance should be chosen ✓ Data should be presented to show that the Ph. Eur. sterilization method and conditions are not feasible.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

17

3.2.P.2 Pharmaceutical Development

CASE STUDY

Hydrocortisone (non-aqueous) dispersion for injection:

• DS is known to be heat sensitive

• Increase of impurities at 25 kGy (ionisation)

• Filtration not suitable because API is dispersed

and due to viscosity of product (non-aqueous)

• Prefiltration of individual components +

aseptic processing is proposed

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

18