Month: July 2024

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

SOP for Analytical Method Development Method Development Phase II: Optimization

SOP for Analytical Method Development Method Development Phase II: Optimization Conducting Phase II Optimization for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting Phase II optimization during the method development process, aiming to refine and improve analytical methods identified in Phase I. 2) Scope This SOP…

Analytical Method Development

SOP for Maintenance of Emergency Generators

SOP for Maintenance of Emergency Generators Standard Operating Procedure for Maintenance of Emergency Generators 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of emergency generators in pharmaceutical manufacturing facilities to ensure reliable backup power supply during power outages. 2) Scope This SOP applies to all emergency generators…

Maintenance Dept.

SOP for Formulation Development Documentation Management

SOP for Formulation Development Documentation Management Managing Documentation in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for managing documentation effectively throughout the formulation development process, ensuring traceability, accuracy, and compliance with regulatory requirements. 2) Scope This SOP applies to all formulation development projects within the organization, covering documentation…

Formulation Development

SOP for Homogeneity Testing in Aerosols

SOP for Homogeneity Testing in Aerosols Standard Operating Procedure for Homogeneity Testing in Aerosols 1) Purpose The purpose of this SOP is to outline procedures for conducting homogeneity testing of aerosol formulations in the pharmaceutical industry. Homogeneity testing ensures uniform distribution of active pharmaceutical ingredients (APIs) and excipients within aerosol products. 2) Scope This SOP…

Aerosols