The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Raw Material CoA Retention Procedure Purpose: To establish a standard procedure for the retention of raw material Certificate of Analysis (CoA) that ensures that the CoA is available when needed and can be retrieved easily. Scope: This SOP applies to the retention of raw material Certificate of Analysis for all raw materials used…
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…
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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SOP for Media Fill Testing: 1.0 Purpose: The purpose of this SOP is to outline the procedure for conducting Media Fill Tests in Pharmaceutical Manufacturing. 2.0 Scope: This SOP applies to all personnel involved in Media Fill Testing in Pharmaceutical Manufacturing. 3.0 Responsibility: 3.1 Quality Assurance – Responsible for reviewing the SOP and ensuring adherence…
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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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Standard Operating Procedure (SOP) for Aseptic Techniques 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for performing aseptic techniques in a laboratory environment to prevent contamination of sterile materials, media, and equipment. 2.0 Scope: This SOP applies to all laboratory personnel who are involved in the handling of sterile…
Standard Operating Procedure (SOP) for Environmental Monitoring 1.0 Purpose: The purpose of this SOP is to provide guidelines for performing environmental monitoring in a laboratory setting. 2.0 Scope: This SOP applies to all personnel involved in performing environmental monitoring in the laboratory. 3.0 Responsibilities: The laboratory personnel responsible for performing environmental monitoring shall: Ensure that…
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