Author: Auditor

SOP for Analytical Method Development Limit of Detection (LOD) Testing

SOP for Analytical Method Development Limit of Detection (LOD) Testing Limit of Detection (LOD) Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting limit of detection (LOD) testing during the analytical method development process, determining the lowest concentration of an analyte that can be reliably…

Analytical Method Development

SOP for Risk Management in Manufacturing Processes

SOP for Risk Management in Manufacturing Processes Standard Operating Procedure for Risk Management in Manufacturing Processes 1) Purpose The purpose of this SOP is to establish procedures for identifying, assessing, controlling, and mitigating risks associated with manufacturing processes within the pharmaceutical facility. 2) Scope This SOP applies to all personnel involved in manufacturing operations, quality…

Injectables

SOP for Pharmacovigilance Line Listing Generation

SOP for Pharmacovigilance Line Listing Generation Guidelines for Generating Pharmacovigilance Line Listings 1) Purpose The purpose of this SOP is to establish standardized procedures for generating line listings of adverse event (AE) data for regulatory reporting and internal analysis. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the creation and review of…

Pharmacovigilance

SOP for Warehouse Management for Aerosol Production

SOP for Warehouse Management for Aerosol Production Standard Operating Procedure for Warehouse Management for Aerosol Production 1) Purpose The purpose of this SOP is to define procedures for the management and control of materials and products stored in warehouses within the aerosol production facility. Effective warehouse management ensures that materials are handled, stored, and distributed…

Aerosols

SOP for Maintenance of Fluid Bed Dryers

SOP for Maintenance of Fluid Bed Dryers Standard Operating Procedure for Maintenance of Fluid Bed Dryers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of fluid bed dryers in pharmaceutical manufacturing facilities to ensure efficient drying processes and product quality. 2) Scope This SOP applies to all…

Maintenance Dept.

SOP for Analytical Method Development Precision Testing

SOP for Analytical Method Development Precision Testing Precision Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting precision testing during the analytical method development process, ensuring the repeatability and reproducibility of the method. 2) Scope This SOP applies to all personnel involved in precision testing…

Analytical Method Development

SOP for Supplier Qualification for Raw Materials in Aerosol Production

SOP for Supplier Qualification for Raw Materials in Aerosol Production Standard Operating Procedure for Supplier Qualification for Raw Materials in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for the qualification and approval of suppliers providing raw materials used in aerosol production. Supplier qualification ensures that raw materials meet specified…

Aerosols

SOP for Pharmacovigilance Aggregate Analysis

SOP for Pharmacovigilance Aggregate Analysis Guidelines for Conducting Pharmacovigilance Aggregate Analysis 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting aggregate analysis of safety data to identify trends, patterns, and potential safety signals. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the analysis of aggregate safety data,…

Pharmacovigilance

SOP for Analytical Method Development Accuracy Testing

SOP for Analytical Method Development Accuracy Testing Accuracy Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting accuracy testing during the analytical method development process, ensuring the closeness of test results to the true value of the analyte. 2) Scope This SOP applies to all…

Analytical Method Development

SOP for Maintenance of Continuous Processing Equipment

SOP for Maintenance of Continuous Processing Equipment Standard Operating Procedure for Maintenance of Continuous Processing Equipment 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of continuous processing equipment in pharmaceutical manufacturing facilities to ensure efficient continuous production processes and product quality. 2) Scope This SOP applies to…

Maintenance Dept.