Friday, 3 May 2019

FDA Issues Draft Guidance on OSD Continuous Manufacturing



FDA has announced the availability of a draft guidance for industry, Quality Considerations for Continuous Manufacturing, which provides information regarding FDA’s current thinking on the quality considerations for continuous manufacturing of small-molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER).

The document addresses areas like:
  • Data storage and handling from process analytical technology systems
  • Potential approaches for situations where direct attribute measurement is not possible (e.g., low dose compounds)
  • Contract manufacturers employing continuous manufacturing
  • Risk-based reporting of routine model maintenance and updates
  • Statistical approaches using large samples (e.g., Large N).

Continuous manufacturing processes are dynamic systems, unlike batch manufacturing processes. During normal operation, a set of critical process parameters and/or quality attributes are kept close to the target values, rather than at a steady-state condition. Transient disturbances may occur during normal operation. 

These are usually small enough to be controllable (i.e., being kept within a desired range). Larger changes in process parameters and quality attributes can happen when a process is in a transient state, such as during start-up and shutdown, a change from one operating condition to another, or significant deviations such as those due to equipment failure or unexpected change in material attributes. 

Understanding of process dynamics as a function of input material attributes (e.g., potency, material flow properties), process conditions (e.g., mass flow rates) or equipment design elements (e.g., blade types for a continuous blender) enables material traceability (the ability to preserve and access the identity and attribute of a material throughout the system) during and after production.

See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM632033.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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