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has announced the availability of a draft guidance for industry, Quality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.pdfPosted by Dr. Tim Sandle, Pharmaceutical Microbiology
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Pharmaceutical Microbiology