The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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)…
1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidance for Sterility Assurance Level (SAL) testing of sterile medical devices and products. 2. Scope: This SOP covers the procedures for conducting SAL testing of sterile medical devices and products. The testing is carried out to ensure that the product is free…
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The Raw Material Sampling Plan Procedure for Water outlined in this SOP is critical to ensuring the quality and safety of the water used in the manufacturing processes. By following this procedure, the company can ensure that all water used in the manufacturing processes meets the specified quality standards and does not pose any health…
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The Raw Material Receipt Procedure outlined in this SOP is critical to ensuring the quality and integrity of the raw materials used in the company’s production processes. By following this procedure, the company can ensure that all raw materials received meet the quality standards set by the company and are stored appropriately to maintain their…
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