Author: Auditor

SOP for Pharmacovigilance Follow-up Procedures

SOP for Pharmacovigilance Follow-up Procedures Guidelines for Pharmacovigilance Follow-up Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting follow-up activities for pharmacovigilance cases to ensure comprehensive data collection and accurate case assessment. 2) Scope This SOP applies to all pharmacovigilance personnel involved in follow-up activities, including safety specialists, case…

Pharmacovigilance

SOP for Maintenance of Cartoning Machines

SOP for Maintenance of Cartoning Machines Standard Operating Procedure for Maintenance of Cartoning Machines 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of cartoning machines in pharmaceutical manufacturing facilities to ensure efficient cartoning processes and product quality. 2) Scope This SOP applies to all cartoning machines used…

Maintenance Dept.

SOP for Formulation Development Comparative Evaluation Studies

SOP for Formulation Development Comparative Evaluation Studies Comparative Evaluation Studies in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting comparative evaluation studies in formulation development, aiming to assess and compare the performance, quality attributes, and characteristics of different formulations or processes to support decision-making and optimization. 2)…

Formulation Development

SOP for CAPA (Corrective and Preventive Actions) Management

SOP for CAPA (Corrective and Preventive Actions) Management Standard Operating Procedure for Corrective and Preventive Actions 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, investigating, and implementing corrective and preventive actions (CAPAs) to address deviations, non-conformances, and potential issues within the pharmaceutical manufacturing processes. 2) Scope This SOP applies…

Injectables

SOP for Change Control in Aerosol Production

SOP for Change Control in Aerosol Production Standard Operating Procedure for Change Control in Aerosol Production 1) Purpose The purpose of this SOP is to establish a controlled and documented process for managing changes in aerosol production. This ensures that all changes are evaluated, approved, and implemented in a way that maintains product quality and…

Aerosols

SOP for Formulation Development Technology Platform Assessment

SOP for Formulation Development Technology Platform Assessment Assessment of Technology Platforms in Formulation Development 1) Purpose The purpose of this SOP is to establish a procedure for the assessment and evaluation of technology platforms in formulation development, ensuring the selection of suitable platforms that align with project requirements, enhance efficiency, and support innovation. 2) Scope…

Formulation Development

SOP for Analytical Method Development Titration Method Development

SOP for Analytical Method Development Titration Method Development Developing Titration Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing titration methods during the analytical method development process, ensuring accurate determination of analyte concentration using titrimetric techniques. 2) Scope This SOP applies to all personnel involved…

Analytical Method Development

SOP for Maintenance of Labeling Machines

SOP for Maintenance of Labeling Machines Standard Operating Procedure for Maintenance of Labeling Machines 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of labeling machines in pharmaceutical manufacturing facilities to ensure accurate labeling processes and product quality. 2) Scope This SOP applies to all labeling machines used…

Maintenance Dept.

SOP for Cleaning Validation in Aerosol Production

SOP for Cleaning Validation in Aerosol Production Standard Operating Procedure for Cleaning Validation in Aerosol Production 1) Purpose The purpose of this SOP is to outline the procedures for performing cleaning validation in aerosol production. Cleaning validation ensures that the cleaning processes consistently remove residues to predetermined levels of acceptability to prevent contamination and cross-contamination….

Aerosols

SOP for Formulation Development Project Closure

SOP for Formulation Development Project Closure Project Closure in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for the systematic and efficient closure of formulation development projects, ensuring that all activities are completed, outcomes are evaluated, and documentation is finalized in accordance with organizational standards. 2) Scope This SOP…

Formulation Development