Tag: ICH Q7 re-test

Re-Test Period Assignment for Bulk vs. Packaged API Materials

Assigning the correct re-test period for active pharmaceutical ingredients (APIs) is a vital part of stability programs and product lifecycle management. The re-test period defines the timeframe during which an API must be retested to confirm continued compliance with specifications before use. Whether an API is stored in bulk or as a packaged form significantly…

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry

Developing SOPs for Retesting Protocols in Stability Programs

Retesting protocols play a critical role in pharmaceutical stability programs, especially for active pharmaceutical ingredients (APIs) and intermediates. These protocols ensure that materials used beyond the initial re-test date continue to meet predefined quality standards. To support compliance, pharma companies must document these procedures in robust Standard Operating Procedures (SOPs). This article guides pharma professionals…

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry

Regulatory Guidance on Using Re-Test Dates in Global Markets

The pharmaceutical industry often faces a complex regulatory landscape when dealing with re-test periods for APIs and intermediates. While shelf life is fixed for finished drug products, re-test periods allow materials like active substances and intermediates to be retested and reused if they remain within specification. However, the rules around how re-test dates should be…

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry

Regulatory Guidance on Using Re-Test Dates in Global Markets

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry