CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.2 Pharmaceutical Development [3]

Manufacturing process:

Explain its rationale and optimization; what are critical parameters (ICH Q12 “established conditions”?) Justify design-space settings in QbD-approach

Overage/physico-chem. Characteristics:

Justify overages/ explain relevant properties

Container Closure System: Rationale for selected primary packaging: - suitability (closure integrity, dosing accuracy) - compatibility (extractables, leachables)

Microbial attributes:

Justify type/ amount of preservatives; type & frequency of controls; aseptic production strategy

Compatibility :

E.g. between product and reconstitution diluents

Guidance: ICH Q8, EMA NtA Vol 2B

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

9

3.2.P.3 Manufacture [1]

Name and Address of Manufacturers ➢ Bulk production/ packaging/ testing/ batch release sites

Batch Formula ➢ Commercial (bulk) batch size(s), including overages, factorization (weigh-in adjustments due to real assay) & production aids ➢ Ranges are acceptable (for variable components or even for whole batches) ➢ Can be split e.g. for key intermediates (tablet cores/ films...) ➢ Other definitions possible than “mass in a bin” (e.g. run -time for continuous manufacturing)

Guidance: EMA guideline „Manufacture of finished Dosage Form“, ICH Q12

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

10

5