The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Maintenance of Chillers Standard Operating Procedure for Maintenance of Chillers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of chillers in pharmaceutical manufacturing facilities to ensure efficient cooling processes. 2) Scope This SOP applies to all chillers used for cooling purposes within the facility premises….
SOP for Analytical Method Development Method Selection Criteria Defining Selection Criteria for Analytical Method Development 1) Purpose The purpose of this SOP is to establish criteria for selecting the most appropriate analytical methods during the method development phase, ensuring that methods chosen meet the required standards of accuracy, precision, and robustness. 2) Scope This SOP…
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SOP for Formulation Development Process Optimization Optimizing Processes in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for optimizing processes during the formulation development phase, aiming to improve efficiency, reduce costs, and enhance product quality. 2) Scope This SOP applies to all formulation development projects within the organization, covering…
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SOP for Filling Accuracy and Volume Checks Standard Operating Procedure for Filling Accuracy and Volume Checks 1) Purpose The purpose of this SOP is to outline procedures for verifying the accuracy and volume of filled products during pharmaceutical manufacturing to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all personnel…
SOP for Formulation Development Stability Testing Conducting Stability Testing for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting stability testing during the formulation development process, ensuring that the formulated product maintains its quality, efficacy, and safety over time. 2) Scope This SOP applies to all formulation development…
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SOP for Process Optimization for Aerosols Standard Operating Procedure for Process Optimization for Aerosols 1) Purpose The purpose of this SOP is to define procedures for optimizing aerosol production processes in the pharmaceutical industry. Process optimization aims to enhance efficiency, improve product quality, and ensure consistency in aerosol manufacturing. 2) Scope This SOP applies to…
SOP for Analytical Method Development Protocol Design Designing Protocols for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for designing protocols for the development of analytical methods, ensuring systematic planning and documentation of method development activities. 2) Scope This SOP applies to all personnel involved in designing protocols…
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SOP for Maintenance of Boilers Standard Operating Procedure for Maintenance of Boilers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of boilers in pharmaceutical manufacturing facilities to ensure safe and efficient steam production. 2) Scope This SOP applies to all boilers used for steam generation within the…
SOP for Pharmacovigilance Signal Detection Guidelines for Pharmacovigilance Signal Detection 1) Purpose The purpose of this SOP is to describe the process for detecting signals from pharmacovigilance data to identify new adverse reactions or changes in the frequency or severity of known adverse reactions. 2) Scope This SOP applies to all pharmacovigilance personnel involved in…
SOP for Formulation Development Prototype Formulation Preparation Preparing Prototype Formulations for Formulation Development 1) Purpose The purpose of this SOP is to provide guidelines for preparing prototype formulations during the formulation development process, ensuring consistency, reproducibility, and alignment with project objectives. 2) Scope This SOP applies to all formulation development projects within the organization, covering…
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