Author: Auditor

SOP for Pharmacovigilance Benefit-Risk Assessment

SOP for Pharmacovigilance Benefit-Risk Assessment Guidelines for Conducting Pharmacovigilance Benefit-Risk Assessment 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting benefit-risk assessments to evaluate the safety and efficacy of medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the benefit-risk assessment process, including safety specialists, data…

Pharmacovigilance

SOP for Continuous Improvement in Manufacturing Operations

SOP for Continuous Improvement in Manufacturing Operations Standard Operating Procedure for Continuous Improvement in Manufacturing Operations 1) Purpose The purpose of this SOP is to define procedures for identifying, implementing, and monitoring continuous improvement initiatives within the pharmaceutical manufacturing operations to enhance efficiency, quality, and compliance. 2) Scope This SOP applies to all personnel involved…

Injectables

SOP for Analytical Method Development Stability Testing of Analytical Solutions

SOP for Analytical Method Development Stability Testing of Analytical Solutions Stability Testing of Analytical Solutions in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting stability testing of analytical solutions during the analytical method development process, ensuring the stability of solutions over time. 2) Scope This SOP…

Analytical Method Development

SOP for Handling Hazardous Materials in Aerosol Production

SOP for Handling Hazardous Materials in Aerosol Production Standard Operating Procedure for Handling Hazardous Materials in Aerosol Production 1) Purpose The purpose of this SOP is to establish safe handling practices for hazardous materials used or generated during aerosol production processes. Proper handling ensures employee safety, environmental protection, and compliance with regulatory requirements. 2) Scope…

Aerosols

SOP for Maintenance of Milling Equipment

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

Maintenance Dept.

SOP for Pharmacovigilance Risk Minimization Measures

SOP for Pharmacovigilance Risk Minimization Measures Guidelines for Implementing Pharmacovigilance Risk Minimization Measures 1) Purpose The purpose of this SOP is to establish standardized procedures for the identification, implementation, and monitoring of risk minimization measures in pharmacovigilance to ensure the safety of medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in…

Pharmacovigilance

SOP for Analytical Method Development Limit of Quantification (LOQ) Testing

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

Analytical Method Development

SOP for Inventory Control in Aerosol Production

SOP for Inventory Control in Aerosol Production Standard Operating Procedure for Inventory Control in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for the systematic control and management of inventory within the aerosol production facility. Effective inventory control ensures accurate tracking, availability of materials, and minimizes the risk of stockouts…

Aerosols

SOP for Maintenance of Spray Dryers

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

Maintenance Dept.

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