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SOP for Stability Sample Management
Stability Sample Management ensures that pharmaceutical products are stored and tested under controlled conditions to evaluate their shelf life, potency, and quality over time. This SOP defines the procedures for handling, storing, and monitoring stability samples in compliance with regulatory guidelines such as ICH Q1A(R2).
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1 Lessons

This SOP outlines the step-by-step process for managing stability samples, including:

  1. Selection and identification of stability samples
  2. Storage conditions and labeling requirements
  3. Schedule for sample withdrawal and testing
  4. Documentation and traceability of stability studies
  5. Handling of deviations or excursions in storage conditions

The objective is to ensure that all stability studies are conducted systematically, maintaining product integrity and regulatory compliance.

Course Content
SOP for Stability Sample Management - Training and Assessment