Month: July 2024

SOP for Start-Up and Shutdown Procedures for FFS Machine

SOP for Start-Up and Shutdown Procedures for FFS Machine Standard Operating Procedure for Start-Up and Shutdown Procedures for Form-Fill-Seal (FFS) Machine 1) Purpose The purpose of this SOP is to establish guidelines for the safe and efficient start-up and shutdown of the Form-Fill-Seal (FFS) machine to ensure consistent production and equipment longevity. 2) Scope This…

Injectables

SOP for Formulation Development Risk Assessment

SOP for Formulation Development Risk Assessment Conducting a Risk Assessment for Formulation Development 1) Purpose The purpose of this SOP is to outline the steps for conducting a risk assessment during the formulation development process to identify, evaluate, and mitigate potential risks that could impact the success of the project. 2) Scope This SOP applies…

Formulation Development

SOP for Analytical Method Development Plan Creation

SOP for Analytical Method Development Plan Creation Creating a Plan for Analytical Method Development 1) Purpose The purpose of this SOP is to describe the process for creating a comprehensive plan for the development of analytical methods, ensuring that all necessary steps, resources, and timelines are clearly defined. 2) Scope This SOP applies to all…

Analytical Method Development

SOP for Pharmacovigilance System Master File (PSMF)

SOP for Pharmacovigilance System Master File (PSMF) Pharmacovigilance System Master File Guidelines 1) Purpose The purpose of this SOP is to define the process for creating, maintaining, and updating the Pharmacovigilance System Master File (PSMF) to ensure compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the preparation, maintenance, and…

Pharmacovigilance

SOP for Maintenance of Forklifts and Pallet Jacks

SOP for Maintenance of Forklifts and Pallet Jacks Standard Operating Procedure for Maintenance of Forklifts and Pallet Jacks 1) Purpose The purpose of this SOP is to establish guidelines for the regular maintenance and inspection of forklifts and pallet jacks to ensure safe and reliable operation in pharmaceutical manufacturing facilities. 2) Scope This SOP applies…

Maintenance Dept.

SOP for Formulation Development Strategy Selection

SOP for Formulation Development Strategy Selection Selecting a Formulation Development Strategy 1) Purpose The purpose of this SOP is to outline the procedure for selecting an appropriate formulation development strategy, ensuring that the chosen strategy aligns with project objectives, regulatory requirements, and resource availability. 2) Scope This SOP applies to all formulation development projects within…

Formulation Development

SOP for Preventing Contamination in Aerosol Production

SOP for Preventing Contamination in Aerosol Production Standard Operating Procedure for Preventing Contamination in Aerosol Production 1) Purpose The purpose of this SOP is to outline procedures for preventing contamination during aerosol production processes in the pharmaceutical industry. Contamination prevention is critical to ensure product quality, safety, and compliance with regulatory requirements. 2) Scope This…

Aerosols

SOP for Analytical Method Development Team Formation

SOP for Analytical Method Development Team Formation Forming a Team for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for forming a team dedicated to the development of analytical methods, ensuring the team comprises individuals with the necessary skills and expertise. 2) Scope This SOP applies to the…

Analytical Method Development

SOP for Formulation Development Plan Creation

SOP for Formulation Development Plan Creation Creating a Formulation Development Plan 1) Purpose The purpose of this SOP is to provide a standardized procedure for creating a comprehensive formulation development plan, outlining all necessary steps, resources, and timelines required to successfully develop a pharmaceutical formulation. 2) Scope This SOP applies to all formulation development projects,…

Formulation Development

Maintenance Dept.: SOP for Continuous Improvement in Maintenance Activities

SOP for Continuous Improvement in Maintenance Activities Standard Operating Procedure for Continuous Improvement in Maintenance Activities 1) Purpose The purpose of this SOP is to establish guidelines for implementing continuous improvement initiatives in maintenance activities within pharmaceutical manufacturing facilities to enhance efficiency, reduce downtime, and optimize resource utilization. 2) Scope This SOP applies to all…

Maintenance Dept.