Author: Auditor

SOP for Equipment Troubleshooting in Aerosol Production

SOP for Equipment Troubleshooting in Aerosol Production Standard Operating Procedure for Equipment Troubleshooting in Aerosol Production 1) Purpose The purpose of this SOP is to provide guidelines for identifying, diagnosing, and resolving equipment issues in aerosol production. Effective troubleshooting ensures minimal downtime, maintains product quality, and promotes safety. 2) Scope This SOP applies to all…

Aerosols

SOP for Pharmacovigilance Case Processing

SOP for Pharmacovigilance Case Processing Guidelines for Processing Pharmacovigilance Cases 1) Purpose The purpose of this SOP is to define the procedures for processing pharmacovigilance cases to ensure timely and accurate reporting of adverse events and other safety information. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the case processing activities, including…

Pharmacovigilance

SOP for Formulation Development Quality by Design (QbD) Principles

SOP for Formulation Development Quality by Design (QbD) Principles Implementing Quality by Design (QbD) Principles in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for implementing Quality by Design (QbD) principles during the formulation development process, ensuring that product quality is built into the formulation design based on scientific…

Formulation Development

SOP for Maintenance of Tablet Presses

SOP for Maintenance of Tablet Presses Standard Operating Procedure for Maintenance of Tablet Presses 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of tablet presses in pharmaceutical manufacturing facilities to ensure efficient tablet production and product quality. 2) Scope This SOP applies to all tablet presses used…

Maintenance Dept.

SOP for Analytical Method Development Forced Degradation Studies

SOP for Analytical Method Development Forced Degradation Studies Conducting Forced Degradation Studies for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting forced degradation studies during the analytical method development process, aimed at evaluating method specificity and stability indicating capability. 2) Scope This SOP applies to all…

Analytical Method Development

SOP for Energy Control Procedures in Aerosol Production

SOP for Energy Control Procedures in Aerosol Production Standard Operating Procedure for Energy Control Procedures in Aerosol Production 1) Purpose The purpose of this SOP is to establish guidelines for controlling energy sources during aerosol production to ensure the safety of personnel and equipment. Proper energy control procedures prevent accidental startup or release of energy…

Aerosols

SOP for Formulation Development Risk Management Plan

SOP for Formulation Development Risk Management Plan Formulating a Risk Management Plan in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for developing a risk management plan during the formulation development process, ensuring that potential risks are identified, assessed, and managed to enhance product quality and safety. 2) Scope…

Formulation Development

SOP for Internal Audits of Manufacturing Processes

SOP for Internal Audits of Manufacturing Processes Standard Operating Procedure for Internal Audits of Manufacturing Processes 1) Purpose The purpose of this SOP is to outline procedures for conducting internal audits of manufacturing processes to verify compliance with regulatory requirements, identify areas for improvement, and ensure consistent product quality. 2) Scope This SOP applies to…

Injectables

SOP for Maintenance of Granulators

SOP for Maintenance of Granulators Standard Operating Procedure for Maintenance of Granulators 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of granulators in pharmaceutical manufacturing facilities to ensure efficient granulation processes and product quality. 2) Scope This SOP applies to all granulators used within the facility premises….

Maintenance Dept.

SOP for Analytical Method Development Stability Indicating Method Development

SOP for Analytical Method Development Stability Indicating Method Development Developing Stability Indicating Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing stability indicating methods during the analytical method development process, ensuring methods capable of detecting and quantifying degradation products in stability studies. 2) Scope This…

Analytical Method Development