The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Stability Study Report Preparation: General steps that can be followed: 1. Identify the objective of the stability study and the regulatory guidelines that need to be adhered to. 2. Collect and record all relevant information for the study such as the product name, lot number, manufacturing date, expiration date, storage conditions, and analytical…
SOPs for stability study protocol preparation: 1. Identify the objective of the stability study clearly. This should include the purpose of the study, the samples being studied, the duration of the study, and the expected outcome. 2. Use established guidelines and regulations such as International Council for Harmonisation (ICH) guidelines and Good Manufacturing Practices (GMP)…
Here is the general outline that can be followed while designing an SOP for Stability Study Design: 1. Objective/Purpose: Define the objective or purpose of the study to ensure that all stakeholders involved understand the expected outcome. 2. Scope: Clearly define the scope of the study to ensure everyone involved is aware of the limitations…