Table 2 Examples of Clinical Lean Stability Strategies
No. | Strategy | Comments |
|---|---|---|
1 | Apply DS stability data (solely) to simplified/DS-based dosage forms, e.g. DS in a bottle or capsule | Justification included in the CTA (also reference section S.7 in P.8) |
2 | Assign initial DS review period of 18 M based on one week 70 °C/75%RH data | Commitment for ‘formal’ program included in CTA |
3 | Use ASAP to determine packaging, long-term storage conditions, to set the initial use period (e.g. 12 month) | Data, conclusions and commitment for ‘formal’ program included in CTA |
4 | Use ASAP to assist in assessing whether a change in DS or DP process, composition or packaging affects stability, and thus need for additional stability program | Inclusion in CTA is case dependent |
5 | Reduce testing protocol (e.g. time points, tests, conditions) based on supportive data | Inclusion of explicit justification in the CTA is case dependent |
6 | Eliminate DS assay testing if it is the same lot as the reference standard | Justification included in the CTA |