The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Pharmacovigilance Data Coding Guidelines for Coding Pharmacovigilance Data 1) Purpose The purpose of this SOP is to define the procedures for coding pharmacovigilance data to ensure standardized and accurate classification of safety information. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the coding of safety data, including data entry operators,…
SOP for Formulation Development Regulatory Filing Regulatory Filing Process in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for filing regulatory submissions during the formulation development process, ensuring compliance with regulatory requirements and facilitating the approval of products for market entry. 2) Scope This SOP applies to all formulation…
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SOP for Use of Propellants in Aerosol Production Standard Operating Procedure for Use of Propellants in Aerosol Production 1) Purpose The purpose of this SOP is to outline procedures for handling and using propellants in aerosol production processes. Proper handling ensures safety, quality, and regulatory compliance throughout the manufacturing process. 2) Scope This SOP applies…
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SOP for Maintenance of Vacuum Systems Standard Operating Procedure for Maintenance of Vacuum Systems 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of vacuum systems in pharmaceutical manufacturing facilities to ensure efficient and reliable operation in critical processes. 2) Scope This SOP applies to all vacuum systems…
SOP for Analytical Method Development Method Transfer Protocol Preparation Preparing Method Transfer Protocol for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for preparing the method transfer protocol during the analytical method development process, ensuring systematic transfer of validated methods between laboratories or sites. 2) Scope This SOP…
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SOP for Formulation Development Regulatory Submission Preparation Preparing Regulatory Submissions in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for preparing regulatory submissions during the formulation development process, ensuring compliance with regulatory requirements and facilitating timely approvals. 2) Scope This SOP applies to all formulation development projects within the…
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SOP for Sample Collection during FFS Operations Standard Operating Procedure for Sample Collection during Form-Fill-Seal (FFS) Operations 1) Purpose The purpose of this SOP is to define procedures for collecting representative samples during Form-Fill-Seal (FFS) operations to ensure product quality and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in…
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SOP for Color Consistency Testing in Aerosols Standard Operating Procedure for Color Consistency Testing in Aerosols 1) Purpose The purpose of this SOP is to establish procedures for assessing color consistency in aerosol formulations. Color consistency testing ensures uniformity and appearance quality of aerosol products throughout their shelf-life. 2) Scope This SOP applies to color…
SOP for Formulation Development Finished Product Testing Testing Finished Products in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for testing finished products during the formulation development process, ensuring that products meet predefined specifications and quality standards before release. 2) Scope This SOP applies to all formulation development projects…
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SOP for Analytical Method Development Method Validation Report Preparation Preparing Method Validation Report for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for preparing the method validation report during the analytical method development process, summarizing validation results and conclusions. 2) Scope This SOP applies to all personnel involved…
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