Month: July 2024

SOP for Formulation Development Technology Transfer

SOP for Formulation Development Technology Transfer Transferring Technology in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for transferring technology during the formulation development process, ensuring seamless transfer of knowledge, processes, and documentation from development to manufacturing. 2) Scope This SOP applies to all formulation development projects within the…

Formulation Development

SOP for Pharmacovigilance Risk Assessment

SOP for Pharmacovigilance Risk Assessment Guidelines for Conducting Pharmacovigilance Risk Assessments 1) Purpose The purpose of this SOP is to define the process for conducting pharmacovigilance risk assessments to identify, evaluate, and mitigate potential risks associated with medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in risk assessment activities, including the…

Pharmacovigilance

SOP for Seal Integrity and Leak Testing

SOP for Seal Integrity and Leak Testing Standard Operating Procedure for Seal Integrity and Leak Testing 1) Purpose The purpose of this SOP is to establish procedures for testing the seal integrity and leakage of packaging for pharmaceutical products to ensure product sterility and quality. 2) Scope This SOP applies to all personnel involved in…

Injectables

SOP for Analytical Method Development Method Development Phase I: Screening

SOP for Analytical Method Development Method Development Phase I: Screening Conducting Phase I Screening for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting Phase I screening during the method development process, aiming to identify initial method candidates for further optimization. 2) Scope This SOP applies to…

Analytical Method Development

SOP for Maintenance of Cooling Towers

SOP for Maintenance of Cooling Towers Standard Operating Procedure for Maintenance of Cooling Towers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of cooling towers in pharmaceutical manufacturing facilities to ensure efficient heat dissipation and water conservation. 2) Scope This SOP applies to all cooling towers used…

Maintenance Dept.

SOP for Sample Collection for Quality Testing in Aerosols

SOP for Sample Collection for Quality Testing in Aerosols Standard Operating Procedure for Sample Collection for Quality Testing in Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the collection of samples during aerosol production for subsequent quality testing. Proper sample collection ensures representative samples are obtained for accurate analysis and…

Aerosols

SOP for Formulation Development Pilot Batch Manufacturing

SOP for Formulation Development Pilot Batch Manufacturing Conducting Pilot Batch Manufacturing in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting pilot batch manufacturing during the formulation development process, aiming to validate the manufacturing process and produce batches for initial stability and performance evaluation. 2) Scope This SOP…

Formulation Development

SOP for Analytical Method Development Pre-screening Studies

SOP for Analytical Method Development Pre-screening Studies Conducting Pre-screening Studies for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting pre-screening studies to identify potential analytical methods for further development, ensuring efficient use of resources and time. 2) Scope This SOP applies to all personnel involved in…

Analytical Method Development

SOP for Formulation Development Scale-Up Studies

SOP for Formulation Development Scale-Up Studies Conducting Scale-Up Studies for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting scale-up studies during the formulation development process, ensuring successful transition from laboratory-scale to commercial-scale production. 2) Scope This SOP applies to all formulation development projects within the organization, covering…

Formulation Development

SOP for Pharmacovigilance Signal Management

SOP for Pharmacovigilance Signal Management Guidelines for Managing Pharmacovigilance Signals 1) Purpose The purpose of this SOP is to outline the procedures for managing pharmacovigilance signals, including their identification, evaluation, prioritization, and documentation, to ensure timely and appropriate action is taken. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the signal management…

Pharmacovigilance