Author: Auditor

SOP for Formulation Development Scale-Up Studies

SOP for Formulation Development Scale-Up Studies Conducting Scale-Up Studies for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting scale-up studies during the formulation development process, ensuring successful transition from laboratory-scale to commercial-scale production. 2) Scope This SOP applies to all formulation development projects within the organization, covering…

Formulation Development

SOP for Pharmacovigilance Signal Management

SOP for Pharmacovigilance Signal Management Guidelines for Managing Pharmacovigilance Signals 1) Purpose The purpose of this SOP is to outline the procedures for managing pharmacovigilance signals, including their identification, evaluation, prioritization, and documentation, to ensure timely and appropriate action is taken. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the signal management…

Pharmacovigilance

SOP for Analytical Method Development for Aerosols

SOP for Analytical Method Development for Aerosols Standard Operating Procedure for Analytical Method Development for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the development and validation of analytical methods used for testing aerosol formulations in the pharmaceutical industry. Analytical method development ensures accurate and reliable analysis of critical quality…

Aerosols

SOP for Maintenance of Chillers

SOP for Maintenance of Chillers Standard Operating Procedure for Maintenance of Chillers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of chillers in pharmaceutical manufacturing facilities to ensure efficient cooling processes. 2) Scope This SOP applies to all chillers used for cooling purposes within the facility premises….

Maintenance Dept.

SOP for Analytical Method Development Method Selection Criteria

SOP for Analytical Method Development Method Selection Criteria Defining Selection Criteria for Analytical Method Development 1) Purpose The purpose of this SOP is to establish criteria for selecting the most appropriate analytical methods during the method development phase, ensuring that methods chosen meet the required standards of accuracy, precision, and robustness. 2) Scope This SOP…

Analytical Method Development

SOP for Formulation Development Process Optimization

SOP for Formulation Development Process Optimization Optimizing Processes in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for optimizing processes during the formulation development phase, aiming to improve efficiency, reduce costs, and enhance product quality. 2) Scope This SOP applies to all formulation development projects within the organization, covering…

Formulation Development

SOP for Filling Accuracy and Volume Checks

SOP for Filling Accuracy and Volume Checks Standard Operating Procedure for Filling Accuracy and Volume Checks 1) Purpose The purpose of this SOP is to outline procedures for verifying the accuracy and volume of filled products during pharmaceutical manufacturing to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all personnel…

Injectables

SOP for Formulation Development Stability Testing

SOP for Formulation Development Stability Testing Conducting Stability Testing for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting stability testing during the formulation development process, ensuring that the formulated product maintains its quality, efficacy, and safety over time. 2) Scope This SOP applies to all formulation development…

Formulation Development

SOP for Process Optimization for Aerosols

SOP for Process Optimization for Aerosols Standard Operating Procedure for Process Optimization for Aerosols 1) Purpose The purpose of this SOP is to define procedures for optimizing aerosol production processes in the pharmaceutical industry. Process optimization aims to enhance efficiency, improve product quality, and ensure consistency in aerosol manufacturing. 2) Scope This SOP applies to…

Aerosols

SOP for Analytical Method Development Protocol Design

SOP for Analytical Method Development Protocol Design Designing Protocols for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for designing protocols for the development of analytical methods, ensuring systematic planning and documentation of method development activities. 2) Scope This SOP applies to all personnel involved in designing protocols…

Analytical Method Development