The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Formulation Development API Selection Selecting Active Pharmaceutical Ingredients for Formulation Development 1) Purpose The purpose of this SOP is to provide a detailed procedure for selecting active pharmaceutical ingredients (APIs) during the formulation development process, ensuring the chosen APIs meet project requirements and regulatory standards. 2) Scope This SOP applies to all formulation…
SOP for Pharmacovigilance Quality Management System Guidelines for Pharmacovigilance Quality Management 1) Purpose The purpose of this SOP is to outline the procedures for establishing, maintaining, and continuously improving the Pharmacovigilance Quality Management System (QMS) to ensure compliance with regulatory requirements and quality standards. 2) Scope This SOP applies to all personnel involved in the…
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SOP for Formulation Development Literature Review Conducting a Literature Review for Formulation Development 1) Purpose The purpose of this SOP is to provide a systematic procedure for conducting a literature review during the formulation development process to gather relevant scientific information, identify gaps, and inform the development strategy. 2) Scope This SOP applies to all…
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SOP for Analytical Method Development Strategy Selection Selecting a Strategy for Analytical Method Development 1) Purpose The purpose of this SOP is to describe the process for selecting the most appropriate strategy for analytical method development, ensuring that the chosen approach is suitable for the specific analytical needs and complies with regulatory requirements. 2) Scope…
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SOP for Maintenance of Clean-in-Place (CIP) Systems Standard Operating Procedure for Maintenance of Clean-in-Place (CIP) Systems 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance, operation, and cleaning of Clean-in-Place (CIP) systems in pharmaceutical manufacturing facilities to ensure effective cleaning and sanitization of processing equipment. 2) Scope This SOP applies…
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SOP for Conducting Process Validation for Aerosols Standard Operating Procedure for Conducting Process Validation for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for conducting process validation activities for aerosol production processes in the pharmaceutical industry. Process validation ensures that aerosol manufacturing processes consistently produce products of the desired quality. 2)…
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SOP for Start-Up and Shutdown Procedures for FFS Machine Standard Operating Procedure for Start-Up and Shutdown Procedures for Form-Fill-Seal (FFS) Machine 1) Purpose The purpose of this SOP is to establish guidelines for the safe and efficient start-up and shutdown of the Form-Fill-Seal (FFS) machine to ensure consistent production and equipment longevity. 2) Scope This…
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SOP for Formulation Development Risk Assessment Conducting a Risk Assessment for Formulation Development 1) Purpose The purpose of this SOP is to outline the steps for conducting a risk assessment during the formulation development process to identify, evaluate, and mitigate potential risks that could impact the success of the project. 2) Scope This SOP applies…
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SOP for Analytical Method Development Plan Creation Creating a Plan for Analytical Method Development 1) Purpose The purpose of this SOP is to describe the process for creating a comprehensive plan for the development of analytical methods, ensuring that all necessary steps, resources, and timelines are clearly defined. 2) Scope This SOP applies to all…
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SOP for Pharmacovigilance System Master File (PSMF) Pharmacovigilance System Master File Guidelines 1) Purpose The purpose of this SOP is to define the process for creating, maintaining, and updating the Pharmacovigilance System Master File (PSMF) to ensure compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the preparation, maintenance, and…
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