Author: Auditor

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

SOP for Analytical Method Development Method Transfer Report Preparation

SOP for Analytical Method Development Method Transfer Report Preparation Preparing Method Transfer Report for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for preparing the method transfer report during the analytical method development process, summarizing the successful transfer of validated methods between laboratories or sites. 2) Scope This…

Analytical Method Development

SOP for Formulation Development Stability Study Monitoring

SOP for Formulation Development Stability Study Monitoring Monitoring Stability Studies in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for monitoring stability studies during the formulation development process, ensuring that stability conditions are maintained and data integrity is preserved. 2) Scope This SOP applies to all formulation development projects…

Formulation Development

SOP for Handling and Disposal of Waste Materials from FFS Machine

SOP for Handling and Disposal of Waste Materials from FFS Machine Standard Operating Procedure for Handling and Disposal of Waste Materials from Form-Fill-Seal (FFS) Machine 1) Purpose The purpose of this SOP is to establish procedures for the safe handling, segregation, and disposal of waste materials generated from the Form-Fill-Seal (FFS) machine operations to ensure…

Injectables

SOP for Maintenance of Centrifuges

SOP for Maintenance of Centrifuges Standard Operating Procedure for Maintenance of Centrifuges 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of centrifuges in pharmaceutical manufacturing facilities to ensure efficient and safe separation processes. 2) Scope This SOP applies to all centrifuges used within the facility premises. 3)…

Maintenance Dept.

SOP for Use of Stabilizers in Aerosol Production

SOP for Use of Stabilizers in Aerosol Production Standard Operating Procedure for Use of Stabilizers in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for the proper use and incorporation of stabilizers in aerosol formulations. Stabilizers ensure product stability, quality, and performance throughout manufacturing and storage. 2) Scope This SOP…

Aerosols