Author: Auditor

SOP for Formulation Development Excipient Selection

SOP for Formulation Development Excipient Selection Selecting Excipients for Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for selecting excipients during the formulation development process, ensuring that the chosen excipients are compatible with the API and meet project and regulatory requirements. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Maintenance of Sterilize-in-Place (SIP) Systems

SOP for Maintenance of Sterilize-in-Place (SIP) Systems Standard Operating Procedure for Maintenance of Sterilize-in-Place (SIP) Systems 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance, operation, and sterilization of Sterilize-in-Place (SIP) systems in pharmaceutical manufacturing facilities to ensure the effective sterilization of processing equipment. 2) Scope This SOP applies to…

Maintenance Dept.

SOP for Analytical Method Development Risk Assessment

SOP for Analytical Method Development Risk Assessment Conducting Risk Assessment for Analytical Method Development 1) Purpose The purpose of this SOP is to describe the procedure for conducting a risk assessment for analytical method development, identifying potential risks, and implementing appropriate mitigation strategies. 2) Scope This SOP applies to all personnel involved in the risk…

Analytical Method Development

SOP for In-process Testing for Aerosols

SOP for In-process Testing for Aerosols Standard Operating Procedure for In-process Testing for Aerosols 1) Purpose The purpose of this SOP is to define procedures for conducting in-process testing during aerosol production in the pharmaceutical industry. In-process testing ensures that critical quality attributes are monitored and controlled throughout the manufacturing process. 2) Scope This SOP…

Aerosols

SOP for Formulation Development API Selection

SOP for Formulation Development API Selection Selecting Active Pharmaceutical Ingredients for Formulation Development 1) Purpose The purpose of this SOP is to provide a detailed procedure for selecting active pharmaceutical ingredients (APIs) during the formulation development process, ensuring the chosen APIs meet project requirements and regulatory standards. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Pharmacovigilance Quality Management System

SOP for Pharmacovigilance Quality Management System Guidelines for Pharmacovigilance Quality Management 1) Purpose The purpose of this SOP is to outline the procedures for establishing, maintaining, and continuously improving the Pharmacovigilance Quality Management System (QMS) to ensure compliance with regulatory requirements and quality standards. 2) Scope This SOP applies to all personnel involved in the…

Pharmacovigilance

SOP for Formulation Development Literature Review

SOP for Formulation Development Literature Review Conducting a Literature Review for Formulation Development 1) Purpose The purpose of this SOP is to provide a systematic procedure for conducting a literature review during the formulation development process to gather relevant scientific information, identify gaps, and inform the development strategy. 2) Scope This SOP applies to all…

Formulation Development

SOP for Analytical Method Development Strategy Selection

SOP for Analytical Method Development Strategy Selection Selecting a Strategy for Analytical Method Development 1) Purpose The purpose of this SOP is to describe the process for selecting the most appropriate strategy for analytical method development, ensuring that the chosen approach is suitable for the specific analytical needs and complies with regulatory requirements. 2) Scope…

Analytical Method Development

SOP for Maintenance of Clean-in-Place (CIP) Systems

SOP for Maintenance of Clean-in-Place (CIP) Systems Standard Operating Procedure for Maintenance of Clean-in-Place (CIP) Systems 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance, operation, and cleaning of Clean-in-Place (CIP) systems in pharmaceutical manufacturing facilities to ensure effective cleaning and sanitization of processing equipment. 2) Scope This SOP applies…

Maintenance Dept.

SOP for Conducting Process Validation for Aerosols

SOP for Conducting Process Validation for Aerosols Standard Operating Procedure for Conducting Process Validation for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for conducting process validation activities for aerosol production processes in the pharmaceutical industry. Process validation ensures that aerosol manufacturing processes consistently produce products of the desired quality. 2)…

Aerosols