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Analytical Procedure Development

View Resource (HTM)

Category

Document

Published on CMKC

Abstract

Guideline provides a foundation for consistent development of analytical methods to maintain precision and accuracy, contirubting to the maintenance of quality products.

Journal

ICH Q14

Type of publication

Document

Affiliations

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Article Classification

Guideline

Classification Areas

  • Regulatory

Tags

  1. Analytical Procedure Lifecycle
  2. Analytical Target Profile
  3. Development of Multivariate Analytical Procedures / Development of Analytical Procedures for Real Ti
  4. Evaluation of Robustness and Parameter changes of analytical procedures / Analytical Procedure Contr
  5. Guideline
  6. Knowledge and Risk Management in Analyticval Prodecure Development and Continual Improvement
  7. Lifecycle Management and Post-Approval Changes of Analytical Procedures / Submission of Analytical P
  8. regulatory