Author: Auditor

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

SOP for Formulation Development Stability Protocol Development

SOP for Formulation Development Stability Protocol Development Developing Stability Protocols in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for developing stability protocols during the formulation development process, ensuring that stability studies are designed and conducted to support product quality and shelf-life determination. 2) Scope This SOP applies to…

Formulation Development

SOP for Analytical Method Development Method Transfer Execution

SOP for Analytical Method Development Method Transfer Execution Executing Method Transfer for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for executing the method transfer during the analytical method development process, ensuring successful transfer of validated methods between laboratories or sites. 2) Scope This SOP applies to all…

Analytical Method Development

SOP for Pharmacovigilance Data Coding

SOP for Pharmacovigilance Data Coding Guidelines for Coding Pharmacovigilance Data 1) Purpose The purpose of this SOP is to define the procedures for coding pharmacovigilance data to ensure standardized and accurate classification of safety information. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the coding of safety data, including data entry operators,…

Pharmacovigilance

SOP for Formulation Development Regulatory Filing

SOP for Formulation Development Regulatory Filing Regulatory Filing Process in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for filing regulatory submissions during the formulation development process, ensuring compliance with regulatory requirements and facilitating the approval of products for market entry. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Use of Propellants in Aerosol Production

SOP for Use of Propellants in Aerosol Production Standard Operating Procedure for Use of Propellants in Aerosol Production 1) Purpose The purpose of this SOP is to outline procedures for handling and using propellants in aerosol production processes. Proper handling ensures safety, quality, and regulatory compliance throughout the manufacturing process. 2) Scope This SOP applies…

Aerosols