Author: Auditor

SOP for Pharmacovigilance Literature Screening

SOP for Pharmacovigilance Literature Screening Guidelines for Conducting Pharmacovigilance Literature Screening 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting literature screening to identify relevant safety information on medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the literature screening process, including safety specialists, medical writers,…

Pharmacovigilance

SOP for Maintenance of Weighing and Dispensing Equipment

SOP for Maintenance of Weighing and Dispensing Equipment Standard Operating Procedure for Maintenance of Weighing and Dispensing Equipment 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of weighing and dispensing equipment in pharmaceutical manufacturing facilities to ensure accurate and reliable weighing processes and product quality. 2) Scope…

Maintenance Dept.

SOP for Deviation Handling in Aerosol Production

SOP for Deviation Handling in Aerosol Production Standard Operating Procedure for Deviation Handling in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, investigating, and resolving deviations from established processes or specifications during aerosol production. Effective deviation handling ensures product quality, regulatory compliance, and continuous process improvement. 2)…

Aerosols

SOP for Analytical Method Development Elemental Impurity Testing

SOP for Analytical Method Development Elemental Impurity Testing Elemental Impurity Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting elemental impurity testing during the analytical method development process, ensuring the identification and quantification of elemental impurities in pharmaceutical products. 2) Scope This SOP applies to…

Analytical Method Development

SOP for Process Validation Protocols for Aerosols

SOP for Process Validation Protocols for Aerosols Standard Operating Procedure for Process Validation Protocols for Aerosols 1) Purpose The purpose of this SOP is to define the procedures for conducting process validation protocols for aerosol production. Process validation ensures that aerosol manufacturing processes consistently produce products of predetermined quality attributes, meeting regulatory and customer requirements….

Aerosols

SOP for Maintenance of Sieving Equipment

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

Maintenance Dept.

SOP for Analytical Method Development Analytical Instrument Qualification (AIQ)

SOP for Analytical Method Development Analytical Instrument Qualification (AIQ) Analytical Instrument Qualification (AIQ) in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting analytical instrument qualification (AIQ) during the analytical method development process, ensuring that analytical instruments meet predefined acceptance criteria. 2) Scope This SOP applies to…

Analytical Method Development

SOP for Pharmacovigilance Benefit-Risk Assessment

SOP for Pharmacovigilance Benefit-Risk Assessment Guidelines for Conducting Pharmacovigilance Benefit-Risk Assessment 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting benefit-risk assessments to evaluate the safety and efficacy of medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the benefit-risk assessment process, including safety specialists, data…

Pharmacovigilance

SOP for Continuous Improvement in Manufacturing Operations

SOP for Continuous Improvement in Manufacturing Operations Standard Operating Procedure for Continuous Improvement in Manufacturing Operations 1) Purpose The purpose of this SOP is to define procedures for identifying, implementing, and monitoring continuous improvement initiatives within the pharmaceutical manufacturing operations to enhance efficiency, quality, and compliance. 2) Scope This SOP applies to all personnel involved…

Injectables

SOP for Analytical Method Development Stability Testing of Analytical Solutions

SOP for Analytical Method Development Stability Testing of Analytical Solutions Stability Testing of Analytical Solutions in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting stability testing of analytical solutions during the analytical method development process, ensuring the stability of solutions over time. 2) Scope This SOP…

Analytical Method Development