Author: Auditor

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

SOP for Formulation Development Deviation Handling

SOP for Formulation Development Deviation Handling Handling Deviations in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for handling deviations during the formulation development process, ensuring that deviations are documented, investigated, and resolved promptly to maintain product quality and compliance with regulatory requirements. 2) Scope This SOP applies to…

Formulation Development

SOP for Pharmacovigilance Database Management

SOP for Pharmacovigilance Database Management Guidelines for Managing Pharmacovigilance Databases 1) Purpose The purpose of this SOP is to define the procedures for managing pharmacovigilance databases to ensure data integrity, security, and accessibility for safety monitoring and reporting. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the management of safety databases, including…

Pharmacovigilance

SOP for Batch Reconciliation in Aerosol Production

SOP for Batch Reconciliation in Aerosol Production Standard Operating Procedure for Batch Reconciliation in Aerosol Production 1) Purpose The purpose of this SOP is to outline the procedures for batch reconciliation in aerosol production. Batch reconciliation ensures that all raw materials, intermediates, and finished products are accurately accounted for, thereby ensuring product quality and regulatory…

Aerosols

SOP for Formulation Development Change Control Management

SOP for Formulation Development Change Control Management Managing Change Control in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for managing change control activities during the formulation development process, ensuring that changes are controlled, documented, and implemented in a systematic manner to maintain product quality and compliance with regulatory…

Formulation Development

SOP for Analytical Method Development Method Lifecycle Management

SOP for Analytical Method Development Method Lifecycle Management Managing Method Lifecycle for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for managing the lifecycle of analytical methods developed within the analytical development department, ensuring ongoing method performance and compliance. 2) Scope This SOP applies to all personnel involved…

Analytical Method Development

SOP for Maintenance of Mixers and Blenders

SOP for Maintenance of Mixers and Blenders Standard Operating Procedure for Maintenance of Mixers and Blenders 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of mixers and blenders in pharmaceutical manufacturing facilities to ensure consistent product quality and operational efficiency. 2) Scope This SOP applies to all…

Maintenance Dept.

SOP for Formulation Development Stability Data Evaluation

SOP for Formulation Development Stability Data Evaluation Evaluating Stability Data in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for evaluating stability data during the formulation development process, ensuring that data integrity is maintained and product stability characteristics are accurately assessed. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Batch Manufacturing Record for Aerosols

SOP for Batch Manufacturing Record for Aerosols Standard Operating Procedure for Batch Manufacturing Record for Aerosols 1) Purpose The purpose of this SOP is to establish guidelines for documenting and controlling the manufacturing process of aerosol batches. A Batch Manufacturing Record (BMR) ensures consistency, traceability, and compliance with regulatory requirements throughout production. 2) Scope This…

Aerosols

SOP for Pharmacovigilance Data Quality Review

SOP for Pharmacovigilance Data Quality Review Guidelines for Reviewing Pharmacovigilance Data Quality 1) Purpose The purpose of this SOP is to establish standardized procedures for reviewing the quality of pharmacovigilance data to ensure accuracy, completeness, and consistency in safety reporting. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the data quality review…

Pharmacovigilance