Author: Auditor

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

SOP for Propellant Testing in Aerosols

SOP for Propellant Testing in Aerosols Standard Operating Procedure for Propellant Testing in Aerosols 1) Purpose The purpose of this SOP is to outline procedures for testing propellants used in aerosol formulations. Propellant testing ensures the quality, safety, and compliance of aerosol products with regulatory requirements. 2) Scope This SOP applies to the testing of…

Aerosols

SOP for Cleaning Between Batch Runs

SOP for Cleaning Between Batch Runs Standard Operating Procedure for Cleaning Between Batch Runs 1) Purpose The purpose of this SOP is to establish procedures for cleaning equipment and manufacturing areas between batch runs to prevent cross-contamination, ensure product quality, and maintain compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved…

Injectables

SOP for Formulation Development Batch Record Review and Approval

SOP for Formulation Development Batch Record Review and Approval Reviewing and Approving Batch Records in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for reviewing and approving batch records during the formulation development process, ensuring accuracy, completeness, and compliance with approved procedures and regulatory requirements. 2) Scope This SOP…

Formulation Development

SOP for Maintenance of Fuel Storage Tanks

SOP for Maintenance of Fuel Storage Tanks Standard Operating Procedure for Maintenance of Fuel Storage Tanks 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of fuel storage tanks in pharmaceutical manufacturing facilities to ensure safe and reliable fuel supply for emergency generators and other critical equipment. 2)…

Maintenance Dept.

SOP for Analytical Method Development Method Development Phase III: Validation

SOP for Analytical Method Development Method Development Phase III: Validation Conducting Phase III Validation for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting Phase III validation during the method development process, aiming to demonstrate that the developed analytical method is suitable for its intended purpose. 2)…

Analytical Method Development

SOP for Pharmacovigilance Risk Management Plan (RMP)

SOP for Pharmacovigilance Risk Management Plan (RMP) Guidelines for Developing Pharmacovigilance Risk Management Plans 1) Purpose The purpose of this SOP is to describe the process for developing and maintaining Pharmacovigilance Risk Management Plans (RMPs) to identify, evaluate, and mitigate risks associated with medicinal products throughout their lifecycle. 2) Scope This SOP applies to all…

Pharmacovigilance

SOP for Assay of Active Ingredient in Aerosols

SOP for Assay of Active Ingredient in Aerosols Standard Operating Procedure for Assay of Active Ingredient in Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the assay of active pharmaceutical ingredients (APIs) in aerosol formulations. Assay testing ensures accurate determination of API content to meet regulatory requirements and product specifications….

Aerosols

SOP for Formulation Development Batch Record Preparation

SOP for Formulation Development Batch Record Preparation Preparing Batch Records in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for preparing batch records during the formulation development process, ensuring accurate documentation of manufacturing activities and compliance with regulatory requirements. 2) Scope This SOP applies to all formulation development projects…

Formulation Development