Based on the intended market for a pharmaceutical/nutraceutical product, the quality control (QC) and Quality Assurance (QA) division of a manufacturer should carefully create the proper stability protocol. The protocol should include a stability study design such as
Sampling time
Strengths
Bracketing
Packaging size
Depending on the demand, it should define the environmental parameters for accelerated and long-term stability, although it is faster to proceed stability at each condition. Based on the data of stability the following decisions are made:
Development of the shelf life
Shelf-life specifications during the expiration period
Assignment of Expiration dates
Stability on an annual basis
Extending the period of expiration
Packaging
Storage requirements
GelEntroCeutics experts will be your trustworthy consultant for A-Z stability design for your target softgel products.