Author: Auditor

SOP for Conducting Internal Audits in Aerosol Production

SOP for Conducting Internal Audits in Aerosol Production Standard Operating Procedure for Conducting Internal Audits in Aerosol Production 1) Purpose The purpose of this SOP is to establish a standardized procedure for conducting internal audits in aerosol production to ensure compliance with regulatory requirements, company policies, and quality standards. Internal audits help identify areas for…

Aerosols

SOP for Change Control in Manufacturing Processes

SOP for Change Control in Manufacturing Processes Standard Operating Procedure for Change Control in Manufacturing Processes 1) Purpose The purpose of this SOP is to establish procedures for initiating, evaluating, implementing, and documenting changes to manufacturing processes to maintain product quality, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel…

Injectables

SOP for Analytical Method Development Chromatographic Method Development

SOP for Analytical Method Development Chromatographic Method Development Developing Chromatographic Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing chromatographic methods during the analytical method development process, ensuring accurate separation and quantification of analytes in pharmaceutical formulations. 2) Scope This SOP applies to all personnel…

Analytical Method Development

SOP for Formulation Development Continuous Improvement Initiatives

SOP for Formulation Development Continuous Improvement Initiatives Continuous Improvement Initiatives in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for implementing continuous improvement initiatives in formulation development, aiming to enhance efficiency, quality, and compliance of formulation processes and practices. 2) Scope This SOP applies to all formulation development activities…

Formulation Development

SOP for Pharmacovigilance Case Assessment

SOP for Pharmacovigilance Case Assessment Guidelines for Assessing Pharmacovigilance Cases 1) Purpose The purpose of this SOP is to establish procedures for the assessment of pharmacovigilance cases to ensure accurate evaluation of adverse event reports and other safety information. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the assessment of case reports,…

Pharmacovigilance

SOP for Formulation Development Process Validation

SOP for Formulation Development Process Validation Validation of Manufacturing Processes in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for process validation in formulation development, ensuring that manufacturing processes consistently produce pharmaceutical products of desired quality attributes and meet regulatory requirements. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Annual Product Review in Aerosol Production

SOP for Annual Product Review in Aerosol Production Standard Operating Procedure for Annual Product Review in Aerosol Production 1) Purpose The purpose of this SOP is to outline the procedures for conducting an annual product review (APR) for aerosol products. The APR is designed to ensure that the product consistently meets quality specifications and regulatory…

Aerosols

SOP for Maintenance of Coating Machines

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

Maintenance Dept.

SOP for Analytical Method Development Particle Size Method Development

SOP for Analytical Method Development Particle Size Method Development Developing Particle Size Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing particle size methods during the analytical method development process, ensuring accurate measurement of particle size distribution in pharmaceutical formulations. 2) Scope This SOP applies…

Analytical Method Development

SOP for Formulation Development Raw Material Specification Development

SOP for Formulation Development Raw Material Specification Development Development of Raw Material Specifications in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for developing raw material specifications in formulation development, ensuring that raw materials used in pharmaceutical formulations meet predefined quality standards and regulatory requirements. 2) Scope This SOP…

Formulation Development