搜尋結果
In Part II F of the dossier, the applicant proposes a shelf life for the medicinal product mainly on the basis of the level of active constituents (efficacy) and the admissible level of any breakdown products or impurities (safety) and consistent
2023年6月16日 · ‘Shelf-life testing’ is that testing performed by QC in order to assure that the released biopharmaceutical drug substance or drug product batch continues to meet its defined required properties through its assigned shelf-life.
- John Geigert
其他人也問了
What does shelf-life specification mean?
What is shelf-life testing?
Do biotechnological/biological products have a shelf-life specification?
What is the difference between drug product release specifications and shelf-life specifications?
The shelf-life should be established with due regard to the climatic zone(s) (see section 2) in which the product is to be marketed. For certain preparations, the shelf-life can be
Process capability is a measure of the risk of failing specification. The spread of the data are compared with the width of th e specifi cati ons. The distance from the mean to the nearest specification relative to half the process width (3s). The index measures actual performance.
- 614KB
- 16
The concept of different acceptance criteria for release vs. shelf-life specifications applies to drug products only; it pertains to the establishment of more restrictive criteria for the release of a drug product than are applied to the shelf-life.
According to ICH Guideline Q6A, a specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other
2020年1月1日 · In addition to describing the regulatory framework for specifications, this chapter provides an overview of the statistical approaches to the development of acceptance criteria to ensure of the potency, purity, and performance over the shelf life of the product. Previouschapter. Nextchapter. Keywords. Critical quality attributes.
