Author: Auditor

SOP for Change Management in Aerosol Production

SOP for Change Management in Aerosol Production Standard Operating Procedure for Change Management in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for initiating, documenting, evaluating, implementing, and verifying changes to processes, equipment, facilities, materials, or documentation in aerosol production. Effective change management ensures controlled and compliant modifications while minimizing…

Aerosols

SOP for Analytical Method Development Method Comparison Studies

SOP for Analytical Method Development Method Comparison Studies Method Comparison Studies in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting method comparison studies during analytical method development, ensuring equivalence between different analytical methods. 2) Scope This SOP applies to all personnel involved in method comparison studies…

Analytical Method Development

SOP for Pharmacovigilance Medical Review

SOP for Pharmacovigilance Medical Review Guidelines for Pharmacovigilance Medical Review 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting medical review of adverse event reports and other safety data in pharmacovigilance. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the medical review process, including medical reviewers, safety…

Pharmacovigilance

SOP for Risk Management in Aerosol Production

SOP for Risk Management in Aerosol Production Standard Operating Procedure for Risk Management in Aerosol Production 1) Purpose The purpose of this SOP is to define procedures for identifying, assessing, mitigating, and managing risks associated with aerosol production processes. Effective risk management ensures product quality, safety, and compliance with regulatory requirements. 2) Scope This SOP…

Aerosols

SOP for Analytical Method Development Reference Standard Management

SOP for Analytical Method Development Reference Standard Management Reference Standard Management in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for managing reference standards used in analytical method development, ensuring their integrity, traceability, and suitability for use. 2) Scope This SOP applies to all personnel involved in reference…

Analytical Method Development

SOP for Maintenance of Distribution Centers

SOP for Maintenance of Distribution Centers Standard Operating Procedure for Maintenance of Distribution Centers 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of distribution centers in pharmaceutical manufacturing facilities to ensure efficient and safe distribution of products. 2) Scope This SOP applies to all distribution centers used…

Maintenance Dept.

SOP for Analytical Method Development Analytical Software Validation

SOP for Analytical Method Development Analytical Software Validation Analytical Software Validation in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for validating analytical software used in analytical method development, ensuring that the software meets predefined requirements for accuracy, reliability, and data integrity. 2) Scope This SOP applies to…

Analytical Method Development

SOP for Stability Testing of IM and SC Injections

SOP for Stability Testing of IM and SC Injections Standard Operating Procedure for Stability Testing of Intramuscular (IM) and Subcutaneous (SC) Injections 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting stability testing of Intramuscular (IM) and Subcutaneous (SC) injections to ensure their safety, efficacy, and quality…

Injectables

SOP for Corrective and Preventive Actions (CAPA) in Aerosol Production

SOP for Corrective and Preventive Actions (CAPA) in Aerosol Production Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, investigating, implementing, and verifying corrective and preventive actions (CAPA) in response to deviations, non-conformances, complaints, or other issues encountered…

Aerosols

SOP for Maintenance of Warehouses

SOP for Maintenance of Warehouses Standard Operating Procedure for Maintenance of Warehouses 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of warehouses in pharmaceutical manufacturing facilities to ensure proper storage and handling of materials and products. 2) Scope This SOP applies to all warehouses used within the…

Maintenance Dept.