FDA and American Association of pharmaceuticals Scientists (AAPS) provided the scientific foundation for the scale-up and postapproval changes required for immediate release product called SUPAC.
SUPAC provides guidelines for postapproval changes in the following
Table of Contents
- Site of manufacturing
- Process and equipment
Significance of Pilot Plant
- Examination of formulae.
- Review of range of relevant processing equipment.
- Production rate adjustment.
- Idea about physical space required.
- Appropriate records and reports to support GMP.
- Identification of critical features to maintain quality.
Advantages of SUPAC
- Members of the production and quality control divisions can readily observe scale-up runs.
- Supplies of excipients and drugs, cleared by the quality control division, can be drawn from the more spacious areas provided to the production division.
- Access to engineering department personnel is provided for equipment installation, maintenance, and repair.
Disadvantages of SUPAC
- The frequency of direct interaction of the formulator with the production personnel in the manufacturing area will be reduced.
- Any problem in manufacturing will be directed towards its pilot-plant personnel.
General Stability Consideration
The effect that SUPAC changes may have on the stability of the drug product should be evaluated. For general guidance on conducting stability studies, see the FDA Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics.
For SUPAC submissions, the following points should also be considered
- In most cases, except those involving scale-up, stability data from pilot-scale batches will be acceptable to support the proposed change.
- Where stability data show a trend towards more potency loss or degrading under accelerated conditions, it is recommended that historical accelerated stability data from a representative perchance batch be submitted for comparison.
- It is also recommended that under these circumstances, all available long-term data on test batches from ongoing studies be provided in the supplement.
- Submission of historical accelerated and available long-term data would facilitate review and approval of the supplement.
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