Author: Auditor

SOP for Evacuation Procedures During Emergencies

SOP for Evacuation Procedures During Emergencies Standard Operating Procedure for Evacuation Procedures During Emergencies 1) Purpose The purpose of this SOP is to establish standardized procedures for safely and efficiently evacuating personnel from the facility during emergencies such as fire, chemical spills, gas leaks, or natural disasters. 2) Scope This SOP applies to all employees,…

Environment, Health and Safety

SOP for Handling and Reporting Shortages in Raw Material Shipments – V 2.0

SOP for Handling and Reporting Shortages in Raw Material Shipments – V 2.0 Standard Operating Procedure for Handling and Reporting Shortages in Raw Material Shipments Department Warehouse / Quality Assurance / Procurement SOP No. SOP/RM/017/2025 Supersedes SOP/RM/017/2022 Page No. Page 1 of 15 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This…

Raw Material Warehouse V 2.0

SOP for Integration of Preclinical Data into IND Submission

SOP for Integration of Preclinical Data into IND Submission Standard Operating Procedure (SOP) for Integration of Preclinical Data into IND Submission 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for integrating preclinical study data into an Investigational New Drug (IND) submission. This SOP ensures that preclinical data is…

Drug Discovery

Ointments: SOP for Pre-Manufacturing Area Cleaning – V 2.0

SOP for Pre-Manufacturing Area Cleaning – V 2.0 Procedure for Pre-Manufacturing Area Cleaning Department Production/Quality Assurance (QA)/Housekeeping SOP No. PM-021 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 (SOP) is…

Ointments V 2.0

SOP for Conducting Fire Drills in Pharmaceutical Facilities

SOP for Conducting Fire Drills in Pharmaceutical Facilities Standard Operating Procedure for Conducting Fire Drills in Pharmaceutical Facilities 1) Purpose The purpose of this SOP is to establish a systematic process for conducting fire drills in pharmaceutical facilities to ensure preparedness, train personnel, and evaluate the effectiveness of emergency response protocols. 2) Scope This SOP…

Environment, Health and Safety

Tablets: SOP for Spray Coating Techniques for Film Coating – V 2.0

Tablets: SOP for Spray Coating Techniques for Film Coating – V 2.0 Standard Operating Procedure for Spray Coating Techniques for Film Coating Department Tablet SOP No. SOP/TAB/021/2025 Supersedes SOP/TAB/021/2022 Page No. Page 1 of 8 Issue Date 24/05/2025 Effective Date 29/05/2025 Review Date 24/05/2026 1. Purpose This SOP defines the spray coating techniques used for…

Tablet Manufacturing V2.0

SOP for Preparing Emergency Response Plans

SOP for Preparing Emergency Response Plans Standard Operating Procedure for Preparing Emergency Response Plans 1) Purpose The purpose of this SOP is to establish a systematic procedure for creating, maintaining, and implementing emergency response plans to address potential risks, safeguard personnel, and protect assets during emergency situations. 2) Scope This SOP applies to all departments…

Environment, Health and Safety

SOP for Conducting Risk Assessments for Waste Management

SOP for Conducting Risk Assessments for Waste Management Standard Operating Procedure for Conducting Risk Assessments for Waste Management 1) Purpose The purpose of this SOP is to provide a structured framework for identifying, analyzing, and mitigating risks associated with waste management activities to ensure safety, regulatory compliance, and environmental protection. 2) Scope This SOP applies…

Environment, Health and Safety

SOP for Preclinical Study Report Preparation

SOP for Preclinical Study Report Preparation Standard Operating Procedure (SOP) for Preclinical Study Report Preparation 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for preparing preclinical study reports. This SOP ensures that study reports are accurately and comprehensively prepared, following the data analysis and interpretation of preclinical studies….

Drug Discovery

SOP for Managing Waste During Emergency Shutdowns

SOP for Managing Waste During Emergency Shutdowns Standard Operating Procedure for Managing Waste During Emergency Shutdowns 1) Purpose The purpose of this SOP is to provide a structured approach for safely managing waste during emergency shutdowns to prevent environmental contamination, ensure regulatory compliance, and mitigate risks associated with unplanned disruptions in operations. 2) Scope This…

Environment, Health and Safety