: While it emphasizes packaging for sterile products , the principles are applicable to any nonporous barrier system protecting a pharmaceutical product.
: Often considered the gold standard for validating a sterile barrier. pda technical report 27 pdf
: The report introduced modernized terms, such as "product package" (instead of container/closure system) and "package seal" to encompass diverse sealing technologies. Lifecycle Integrity Assessment : While it emphasizes packaging for sterile products
The report provides guidance on choosing appropriate methods based on the specific product and packaging material. Common methodologies discussed or referenced in relation to TR 27 include: pda technical report 27 pdf
TR 27 has significantly influenced regulatory expectations from the and EMA regarding sterile drug quality. By emphasizing science-based validation over simple "pass/fail" end-product testing, it has helped the industry reduce risks associated with contamination, which remains a leading cause of parenteral drug recalls.