API and formulation stability study requirements and common problem sample batches:
The stability test should use at least "samples of pilot-scale batches". Packaging materials/containers: should be consistent with the packaging to be marketed. Influencing factor test: 1 batch of chemical products; Biological products: 3 batches. Accelerated and long-term trials: 3 batches. [The change needs to be based on the degree of change, and the required batches are different] The accelerated test and long-term test placement conditions should be reasonably selected according to the storage conditions. After a significant change, an intermediate placement condition should be added. Some dosage forms can be used directly at 30°C±2°C, RH65% ±5% for accelerated testing. Based on the variety, the inspection items should be added/decreased (do not completely copy the requirements in the pharmacopoeia), which can reflect the changes in product quality. Lofting requirements in the stability investigation: the liquid preparation should be placed forward, backward, and horizontally (possibly) to investigate the compatibility of the product and the packaging material