The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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…
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…
Read More “SOP for Formulation Development Stability Testing” »
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…
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…
Read More “SOP for Analytical Method Development Protocol Design” »
SOP for Maintenance of Boilers Standard Operating Procedure for Maintenance of Boilers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of boilers in pharmaceutical manufacturing facilities to ensure safe and efficient steam production. 2) Scope This SOP applies to all boilers used for steam generation within the…
SOP for Pharmacovigilance Signal Detection Guidelines for Pharmacovigilance Signal Detection 1) Purpose The purpose of this SOP is to describe the process for detecting signals from pharmacovigilance data to identify new adverse reactions or changes in the frequency or severity of known adverse reactions. 2) Scope This SOP applies to all pharmacovigilance personnel involved in…
SOP for Formulation Development Prototype Formulation Preparation Preparing Prototype Formulations for Formulation Development 1) Purpose The purpose of this SOP is to provide guidelines for preparing prototype formulations during the formulation development process, ensuring consistency, reproducibility, and alignment with project objectives. 2) Scope This SOP applies to all formulation development projects within the organization, covering…
Read More “SOP for Formulation Development Prototype Formulation Preparation” »
SOP for Formulation Development for Aerosols Standard Operating Procedure for Formulation Development for Aerosols 1) Purpose The purpose of this SOP is to outline procedures for the development of aerosol formulations in the pharmaceutical industry. Formulation development ensures the creation of stable, efficacious, and safe aerosol products meeting regulatory and quality standards. 2) Scope This…
SOP for Analytical Method Development Feasibility Studies Conducting Feasibility Studies for Analytical Method Development 1) Purpose The purpose of this SOP is to describe the procedure for conducting feasibility studies as part of the analytical method development process, ensuring that potential methods are evaluated for their practicality and effectiveness. 2) Scope This SOP applies to…
Read More “SOP for Analytical Method Development Feasibility Studies” »
SOP for Formulation Development Pre-formulation Studies Conducting Pre-formulation Studies for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting pre-formulation studies during the formulation development process, aiming to gather critical information about the physical and chemical properties of the active pharmaceutical ingredient (API) and excipients. 2) Scope This…
Read More “SOP for Formulation Development Pre-formulation Studies” »