The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Homogeneity Testing in Aerosols Standard Operating Procedure for Homogeneity Testing in Aerosols 1) Purpose The purpose of this SOP is to outline procedures for conducting homogeneity testing of aerosol formulations in the pharmaceutical industry. Homogeneity testing ensures uniform distribution of active pharmaceutical ingredients (APIs) and excipients within aerosol products. 2) Scope This SOP…
SOP for Formulation Development Technology Transfer Transferring Technology in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for transferring technology during the formulation development process, ensuring seamless transfer of knowledge, processes, and documentation from development to manufacturing. 2) Scope This SOP applies to all formulation development projects within the…
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SOP for Pharmacovigilance Risk Assessment Guidelines for Conducting Pharmacovigilance Risk Assessments 1) Purpose The purpose of this SOP is to define the process for conducting pharmacovigilance risk assessments to identify, evaluate, and mitigate potential risks associated with medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in risk assessment activities, including the…
SOP for Seal Integrity and Leak Testing Standard Operating Procedure for Seal Integrity and Leak Testing 1) Purpose The purpose of this SOP is to establish procedures for testing the seal integrity and leakage of packaging for pharmaceutical products to ensure product sterility and quality. 2) Scope This SOP applies to all personnel involved in…
SOP for Analytical Method Development Method Development Phase I: Screening Conducting Phase I Screening for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting Phase I screening during the method development process, aiming to identify initial method candidates for further optimization. 2) Scope This SOP applies to…
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SOP for Maintenance of Cooling Towers Standard Operating Procedure for Maintenance of Cooling Towers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of cooling towers in pharmaceutical manufacturing facilities to ensure efficient heat dissipation and water conservation. 2) Scope This SOP applies to all cooling towers used…
SOP for Sample Collection for Quality Testing in Aerosols Standard Operating Procedure for Sample Collection for Quality Testing in Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the collection of samples during aerosol production for subsequent quality testing. Proper sample collection ensures representative samples are obtained for accurate analysis and…
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SOP for Formulation Development Pilot Batch Manufacturing Conducting Pilot Batch Manufacturing in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting pilot batch manufacturing during the formulation development process, aiming to validate the manufacturing process and produce batches for initial stability and performance evaluation. 2) Scope This SOP…
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SOP for Analytical Method Development Pre-screening Studies Conducting Pre-screening Studies for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting pre-screening studies to identify potential analytical methods for further development, ensuring efficient use of resources and time. 2) Scope This SOP applies to all personnel involved in…
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SOP for Formulation Development Scale-Up Studies Conducting Scale-Up Studies for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting scale-up studies during the formulation development process, ensuring successful transition from laboratory-scale to commercial-scale production. 2) Scope This SOP applies to all formulation development projects within the organization, covering…
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