Author: Auditor

Pharmacovigilance: SOP for Pharmacovigilance Data Entry

SOP for Pharmacovigilance Data Entry Guidelines for Entering Pharmacovigilance Data 1) Purpose The purpose of this SOP is to establish the procedures for accurately and efficiently entering pharmacovigilance data into the database to ensure data integrity and facilitate timely safety monitoring and reporting. 2) Scope This SOP applies to all pharmacovigilance personnel involved in data…

Pharmacovigilance

SOP for Maintenance of Compressed Gas Systems

SOP for Maintenance of Compressed Gas Systems Standard Operating Procedure for Maintenance of Compressed Gas Systems 1) Purpose The purpose of this SOP is to establish guidelines for the safe maintenance and operation of compressed gas systems in pharmaceutical manufacturing facilities to ensure reliability and safety in handling gases. 2) Scope This SOP applies to…

Maintenance Dept.

SOP for Formulation Development In-process Testing

SOP for Formulation Development In-process Testing Performing In-process Testing in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting in-process testing during the formulation development process, ensuring that critical parameters are monitored and controlled to achieve consistent product quality. 2) Scope This SOP applies to all formulation development…

Formulation Development

SOP for Analytical Method Development Method Validation Execution

SOP for Analytical Method Development Method Validation Execution Executing Method Validation for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for executing method validation during the analytical method development process, ensuring that the developed method meets predefined acceptance criteria and regulatory requirements. 2) Scope This SOP applies to…

Analytical Method Development

SOP for Preservative Efficacy Testing in Aerosols

SOP for Preservative Efficacy Testing in Aerosols Standard Operating Procedure for Preservative Efficacy Testing in Aerosols 1) Purpose The purpose of this SOP is to establish procedures for evaluating the effectiveness of preservatives used in aerosol formulations. Preservative efficacy testing ensures microbiological safety and stability of aerosol products throughout their shelf-life. 2) Scope This SOP…

Aerosols

SOP for Formulation Development Analytical Method Validation

SOP for Formulation Development Analytical Method Validation Validating Analytical Methods in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for validating analytical methods during the formulation development process, ensuring methods are suitable for intended use, accurate, and reliable. 2) Scope This SOP applies to all formulation development projects within…

Formulation Development

SOP for Equipment Decommissioning and Disposal

SOP for Equipment Decommissioning and Disposal Standard Operating Procedure for Equipment Decommissioning and Disposal 1) Purpose The purpose of this SOP is to establish guidelines for the proper decommissioning and disposal of equipment in pharmaceutical manufacturing facilities to ensure compliance with environmental regulations and safety standards. 2) Scope This SOP applies to all equipment that…

Maintenance Dept.

SOP for Pharmacovigilance Data Collection

SOP for Pharmacovigilance Data Collection Guidelines for Collecting Pharmacovigilance Data 1) Purpose The purpose of this SOP is to outline the standardized procedures for collecting pharmacovigilance data to ensure accurate, consistent, and timely data capture for safety monitoring and reporting. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the data collection process,…

Pharmacovigilance

SOP for Analytical Method Development Method Validation Protocol Preparation

SOP for Analytical Method Development Method Validation Protocol Preparation Preparing Method Validation Protocol for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for preparing the method validation protocol during the analytical method development process, ensuring systematic planning and documentation of validation activities. 2) Scope This SOP applies to…

Analytical Method Development

SOP for Formulation Development Analytical Method Development

SOP for Formulation Development Analytical Method Development Developing Analytical Methods in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for developing analytical methods during the formulation development process, ensuring robust methods for assessing product quality and performance. 2) Scope This SOP applies to all formulation development projects within the…

Formulation Development