Science and Risked-Based Stability Testing Strategies-a Test Case on the Global Implementation and Regulatory...

Area of Science:

• Pharmaceutical Sciences
• Regulatory Affairs

Background:

• Science and Risk-Based (SRB) strategies, or "lean stability," aim to optimize drug product stability testing.
• Traditional stability protocols often involve extensive testing, which can be resource-intensive.

Purpose of the Study:

• To review the global regulatory implementation and acceptance of SRB strategies for stable drug products.
• To evaluate the application of an SRB strategy to a new solid dosage form line extension.

Main Methods:

• A case study involving a product line extension for a well-understood product was used.
• The stability protocol proposed a reduction in analytical tests and time points, aligning with ICH and WHO guidelines.
• Global regulatory filings were made to assess acceptance of the reduced stability testing approach.

Main Results:

• The SRB strategy was not universally accepted by regulatory authorities.
• The strategy facilitated productive discussions with regulators in several countries regarding the use of product knowledge and development data.
• The approach demonstrated the potential for a "fit for purpose" stability protocol.

Conclusions:

• Continued industry efforts towards product-specific protocols based on risk assessments are crucial for wider acceptance of SRB strategies.
• Leveraging product understanding and development knowledge is key to developing effective and efficient stability protocols.
• Further dialogue and consistent application of SRB strategies are expected to increase global regulatory acceptance.