The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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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SOP for Formulation Development for Aerosols Standard Operating Procedure for Formulation Development for Aerosols 1) Purpose The purpose of this SOP is to outline procedures for the development of aerosol formulations in the pharmaceutical industry. Formulation development ensures the creation of stable, efficacious, and safe aerosol products meeting regulatory and quality standards. 2) Scope This…
SOP for Analytical Method Development Feasibility Studies Conducting Feasibility Studies for Analytical Method Development 1) Purpose The purpose of this SOP is to describe the procedure for conducting feasibility studies as part of the analytical method development process, ensuring that potential methods are evaluated for their practicality and effectiveness. 2) Scope This SOP applies to…
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SOP for Formulation Development Pre-formulation Studies Conducting Pre-formulation Studies for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting pre-formulation studies during the formulation development process, aiming to gather critical information about the physical and chemical properties of the active pharmaceutical ingredient (API) and excipients. 2) Scope This…
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SOP for Preventive Maintenance of HVAC Filters Standard Operating Procedure for Preventive Maintenance of HVAC Filters 1) Purpose The purpose of this SOP is to establish guidelines for the preventive maintenance of HVAC (Heating, Ventilation, and Air Conditioning) filters in pharmaceutical manufacturing facilities to ensure efficient operation and indoor air quality. 2) Scope This SOP…
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SOP for Pharmacovigilance Training Program Pharmacovigilance Training Guidelines 1) Purpose The purpose of this SOP is to define the process for developing, implementing, and maintaining a comprehensive pharmacovigilance training program to ensure all relevant staff are knowledgeable about pharmacovigilance requirements and practices. 2) Scope This SOP applies to all personnel involved in pharmacovigilance activities and…
SOP for Formulation Development Compatibility Studies Conducting Compatibility Studies for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting compatibility studies during the formulation development process to ensure that the active pharmaceutical ingredient (API) and excipients are compatible and stable under various conditions. 2) Scope This SOP applies…
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SOP for Analytical Method Development Literature Review Conducting Literature Review for Analytical Method Development 1) Purpose The purpose of this SOP is to describe the procedure for conducting a comprehensive literature review as part of the analytical method development process, ensuring that all relevant scientific and regulatory information is gathered and reviewed. 2) Scope This…
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SOP for Emergency Shutdown and Restart Procedures Standard Operating Procedure for Emergency Shutdown and Restart Procedures 1) Purpose The purpose of this SOP is to define the steps and protocols for safely shutting down and restarting manufacturing equipment in case of emergencies to protect personnel and minimize equipment damage. 2) Scope This SOP applies to…
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