CRED Getting the CMC Dossier Right 2024

05/09/2024

Parenteral Dosage Forms – Key Considerations

• Sterile forms have highest demands in terms of GMP

• Preferred choice is terminal sterilisation (autoclaving)

• For products that cannot be autoclaved – aseptic processing of pre-sterilised components in sterile environment

• Bioburden has to be minimised by good manufacturing controls

• Key steps are pre-filtration followed by final 0.2um filter

• Compatibility (extractables, leachables) with manufacturing equipment (tubing and filters), pack, closures and admixtures

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Inhalation Products

• Metered dose device containing powders (could be active ingredient alone or mixed with excipient – usually lactose) or pressurised aerosols • Delivery device is critical for accurate dosing and patients need training and very clear instructions as proper use and compliance is often poor • Delivered particles need to be 1-2um to reach the required areas of the lung

• Consider development of training aids

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