Author: Auditor

SOP for Adverse Reaction Reporting for Aerosols

SOP for Adverse Reaction Reporting for Aerosols Standard Operating Procedure for Adverse Reaction Reporting for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the timely and accurate reporting of adverse reactions associated with aerosol products. This ensures compliance with regulatory requirements and supports ongoing product safety monitoring and risk management….

Aerosols

SOP for Pharmacovigilance Risk Evaluation and Mitigation Strategy (REMS)

SOP for Pharmacovigilance Risk Evaluation and Mitigation Strategy (REMS) Guidelines for Pharmacovigilance Risk Evaluation and Mitigation Strategy (REMS) 1) Purpose The purpose of this SOP is to outline procedures for developing and implementing Risk Evaluation and Mitigation Strategies (REMS) in pharmacovigilance. 2) Scope This SOP applies to all pharmacovigilance personnel involved in REMS development and…

Pharmacovigilance

SOP for Maintenance Training and Qualification

SOP for Maintenance Training and Qualification Standard Operating Procedure for Maintenance Training and Qualification 1) Purpose The purpose of this SOP is to establish guidelines for training and qualifying maintenance personnel in pharmaceutical manufacturing facilities to ensure competency and compliance with maintenance procedures. 2) Scope This SOP applies to all maintenance personnel involved in equipment…

Maintenance Dept.

SOP for Post-Market Surveillance for Aerosols

SOP for Post-Market Surveillance for Aerosols Standard Operating Procedure for Post-Market Surveillance for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for monitoring the safety and performance of aerosol products in the market after regulatory approval. This includes the systematic collection, analysis, and reporting of post-market surveillance data to ensure continuous…

Aerosols

SOP for Homogeneity Testing

SOP for Homogeneity Testing Standard Operating Procedure for Homogeneity Testing 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting homogeneity testing of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure uniform distribution of the active pharmaceutical ingredient (API) throughout the product. 2) Scope This…

Injectables

SOP for Pharmacovigilance Inspection Readiness

SOP for Pharmacovigilance Inspection Readiness Guidelines for Pharmacovigilance Inspection Readiness 1) Purpose The purpose of this SOP is to establish procedures for ensuring pharmacovigilance activities are inspection-ready at all times. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for maintaining inspection readiness, including pharmacovigilance managers, quality assurance officers, and compliance specialists. 3) Responsibilities…

Pharmacovigilance

SOP for Regulatory Submission for Aerosols

SOP for Regulatory Submission for Aerosols Standard Operating Procedure for Regulatory Submission for Aerosols 1) Purpose The purpose of this SOP is to define procedures for the preparation, compilation, and submission of regulatory documents related to aerosol products. This ensures compliance with regulatory requirements and facilitates the approval process for marketing authorization. 2) Scope This…

Aerosols

SOP for Calibration of pH Meters

SOP for Calibration of pH Meters Standard Operating Procedure for Calibration of pH Meters 1) Purpose The purpose of this SOP is to define the procedure for calibrating pH meters to ensure accurate and reliable pH measurements in pharmaceutical manufacturing. 2) Scope This SOP applies to all pH meters used within the facility premises. 3)…

Maintenance Dept.

SOP for Clinical Trial Material Production for Aerosols

SOP for Clinical Trial Material Production for Aerosols Standard Operating Procedure for Clinical Trial Material Production for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the production of clinical trial materials (CTM) in aerosol format. This ensures adherence to regulatory requirements, consistency in production, and the generation of reliable data…

Aerosols

SOP for Pharmacovigilance Audit Preparation

SOP for Pharmacovigilance Audit Preparation Guidelines for Pharmacovigilance Audit Preparation 1) Purpose The purpose of this SOP is to outline procedures for preparing pharmacovigilance activities and documentation for internal and external audits. 2) Scope This SOP applies to all pharmacovigilance personnel involved in audit preparation, including pharmacovigilance managers, quality assurance officers, and compliance specialists. 3)…

Pharmacovigilance