Author: Auditor

SOP for HVAC System Maintenance in Aerosol Production

SOP for HVAC System Maintenance in Aerosol Production Standard Operating Procedure for HVAC System Maintenance in Aerosol Production 1) Purpose The purpose of this SOP is to outline the procedures for maintaining the Heating, Ventilation, and Air Conditioning (HVAC) systems in aerosol production areas. Proper maintenance ensures that the HVAC systems operate efficiently, providing controlled…

Aerosols

SOP for Formulation Development Clinical Trial Material Manufacturing

SOP for Formulation Development Clinical Trial Material Manufacturing Clinical Trial Material Manufacturing in Formulation Development 1) Purpose The purpose of this SOP is to establish procedures for the manufacturing of clinical trial materials (CTMs) in formulation development, ensuring adherence to Good Manufacturing Practices (GMP), compliance with regulatory requirements, and facilitation of clinical trials. 2) Scope…

Formulation Development

SOP for Analytical Method Development Robustness Testing

SOP for Analytical Method Development Robustness Testing Robustness Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting robustness testing during the analytical method development process, ensuring the reliability and robust performance of analytical methods under varying conditions. 2) Scope This SOP applies to all personnel…

Analytical Method Development

SOP for Maintenance of Bottling Lines

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

Maintenance Dept.

SOP for Formulation Development Market Analysis

SOP for Formulation Development Market Analysis Market Analysis in Formulation Development 1) Purpose The purpose of this SOP is to outline procedures for conducting comprehensive market analysis in formulation development, facilitating informed decision-making, identifying market opportunities, and supporting strategic planning and product development. 2) Scope This SOP applies to the market analysis activities conducted within…

Formulation Development

SOP for Pharmacovigilance Expedited Reporting

SOP for Pharmacovigilance Expedited Reporting Guidelines for Expedited Pharmacovigilance Reporting 1) Purpose The purpose of this SOP is to establish standardized procedures for expedited reporting of serious adverse events (SAEs) to regulatory authorities to ensure timely communication and compliance with regulatory requirements. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the reporting…

Pharmacovigilance

SOP for Analytical Method Development System Suitability Testing

SOP for Analytical Method Development System Suitability Testing System Suitability Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting system suitability testing (SST) during the analytical method development process, ensuring the reliability and reproducibility of analytical systems and methods. 2) Scope This SOP applies to…

Analytical Method Development

SOP for Personnel Hygiene in Aerosol Production

SOP for Personnel Hygiene in Aerosol Production Standard Operating Procedure for Personnel Hygiene in Aerosol Production 1) Purpose The purpose of this SOP is to establish guidelines for maintaining hygiene practices among personnel involved in aerosol production. This ensures that personnel hygiene standards are maintained to prevent contamination of aerosol products and comply with regulatory…

Aerosols

SOP for Formulation Development Vendor Management

SOP for Formulation Development Vendor Management Vendor Management in Formulation Development 1) Purpose The purpose of this SOP is to establish procedures for effectively managing vendor relationships and ensuring the delivery of high-quality materials, equipment, and services essential to formulation development activities, thereby supporting operational efficiency and compliance with regulatory requirements. 2) Scope This SOP…

Formulation Development

SOP for Maintenance of Strip Packaging Machines

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

Maintenance Dept.