Author: Auditor

SOP for Analysis of Protein Binding in Drug Development

SOP for Analysis of Protein Binding in Drug Development Standard Operating Procedure (SOP) for Analysis of Protein Binding in Drug Development 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for analyzing protein binding in drug development. Protein binding is a critical pharmacokinetic property that influences the distribution, metabolism,…

Drug Discovery

SOP for Ensuring Business Continuity During Emergencies

SOP for Ensuring Business Continuity During Emergencies Standard Operating Procedure for Ensuring Business Continuity During Emergencies 1) Purpose The purpose of this SOP is to provide a structured approach for maintaining essential operations and minimizing disruptions during emergencies such as natural disasters, pandemics, cyberattacks, or equipment failures. 2) Scope This SOP applies to all departments…

Environment, Health and Safety

Ointments: SOP for Process Equipment Calibration in Manufacturing – V 2.0

SOP for Process Equipment Calibration in Manufacturing – V 2.0 Procedure for Process Equipment Calibration in Manufacturing Department Engineering/Quality Assurance (QA)/Production SOP No. PE-029 Supersedes V 1.0 Page No. Page X of Y Issue Date [Insert Issue Date] Effective Date [Insert Effective Date] Review Date [Insert Review Date] 1. Purpose The purpose of this Standard…

Ointments V 2.0

SOP for Responding to Pandemic Outbreaks in Manufacturing Sites

SOP for Responding to Pandemic Outbreaks in Manufacturing Sites Standard Operating Procedure for Responding to Pandemic Outbreaks in Manufacturing Sites 1) Purpose The purpose of this SOP is to establish a comprehensive response plan for managing pandemic outbreaks in manufacturing sites to ensure the safety of employees, maintain operational continuity, and comply with public health…

Environment, Health and Safety

Tablets: SOP for Anti-Dusting Measures in Tablet Compression – V 2.0

Tablets: SOP for Anti-Dusting Measures in Tablet Compression – V 2.0 Standard Operating Procedure for Anti-Dusting Measures in Tablet Compression Department Tablet SOP No. SOP/TAB/029/2025 Supersedes SOP/TAB/029/2022 Page No. Page 1 of 6 Issue Date 03/07/2025 Effective Date 08/07/2025 Review Date 03/07/2026 1. Purpose This SOP defines the procedures for implementing anti-dusting measures during tablet…

Tablet Manufacturing V2.0

SOP for Emergency Decontamination Procedures

SOP for Emergency Decontamination Procedures Standard Operating Procedure for Emergency Decontamination Procedures 1) Purpose The purpose of this SOP is to establish a clear process for safely conducting emergency decontamination procedures to minimize health risks, prevent contamination spread, and protect personnel, equipment, and the environment during chemical or biological exposure incidents. 2) Scope This SOP…

Environment, Health and Safety

SOP for Phototoxicity Testing in Preclinical Studies

SOP for Phototoxicity Testing in Preclinical Studies Standard Operating Procedure (SOP) for Phototoxicity Testing in Preclinical Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting phototoxicity testing in preclinical studies. Phototoxicity testing is essential for assessing the potential of a drug or chemical compound to cause…

Drug Discovery

SOP for Receiving Raw Materials Packed in Drums, Bags, and Carboys – V 2.0

SOP for Receiving Raw Materials Packed in Drums, Bags, and Carboys – V 2.0 Standard Operating Procedure for Receiving Raw Materials Packed in Drums, Bags, and Carboys Department Warehouse / Quality Assurance / Procurement SOP No. SOP/RM/023/2025 Supersedes SOP/RM/023/2022 Page No. Page 1 of 15 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1….

Raw Material Warehouse V 2.0

SOP for Managing Emergency Transportation of Injured Workers

SOP for Managing Emergency Transportation of Injured Workers Standard Operating Procedure for Managing Emergency Transportation of Injured Workers 1) Purpose The purpose of this SOP is to establish a structured procedure for safely and efficiently transporting injured workers to medical facilities during emergencies, ensuring their health and safety are prioritized. 2) Scope This SOP applies…

Environment, Health and Safety

Ointments: SOP for Sampling During Manufacturing – V 2.0

SOP for Sampling During Manufacturing – V 2.0 Procedure for Sampling During Manufacturing Department Production/Quality Assurance (QA)/Quality Control (QC) SOP No. SOP/Ointment/028 Supersedes V 1.0 Page No. Page X of Y Issue Date [Insert Issue Date] Effective Date [Insert Effective Date] Review Date [Insert Review Date] 1. Purpose The purpose of this Standard Operating Procedure…

Ointments V 2.0