The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for PK/PD Modeling in Preclinical Studies Standard Operating Procedure (SOP) for PK/PD Modeling in Preclinical Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for performing pharmacokinetic (PK) and pharmacodynamic (PD) modeling in preclinical studies. PK/PD modeling is essential for understanding the relationship between the drug concentration…
Tablets: SOP for Using Fluidized Bed Processor in Tablet Manufacturing – V 2.0 Standard Operating Procedure for Using Fluidized Bed Processor in Tablet Manufacturing Department Tablet SOP No. SOP/TAB/024/2025 Supersedes SOP/TAB/024/2022 Page No. Page 1 of 8 Issue Date 08/06/2025 Effective Date 13/06/2025 Review Date 08/06/2026 1. Purpose This SOP outlines the procedures for using…
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SOP for Checking Raw Material Shipment against Approved Purchase Order (PO) – V 2.0 Standard Operating Procedure for Checking Raw Material Shipment against Approved Purchase Order (PO) Department Warehouse / Procurement / Quality Assurance SOP No. SOP/RM/019/2025 Supersedes SOP/RM/019/2022 Page No. Page 1 of 14 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1….
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SOP for Earthquake Response Plans in Manufacturing Facilities Standard Operating Procedure for Earthquake Response Plans in Manufacturing Facilities 1) Purpose The purpose of this SOP is to establish a systematic plan to ensure the safety of personnel, minimize damage to equipment and property, and facilitate efficient recovery in the event of an earthquake. 2) Scope…
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SOP for Handling Flooding in Manufacturing Areas Standard Operating Procedure for Handling Flooding in Manufacturing Areas 1) Purpose The purpose of this SOP is to provide guidelines for effectively managing flooding in manufacturing areas to ensure personnel safety, minimize equipment damage, and prevent operational downtime. 2) Scope This SOP applies to all manufacturing areas within…
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SOP for Heating and Melting Base Materials – V 2.0 Procedure for Heating and Melting Base Materials Department Production/Engineering/Quality Assurance (QA) SOP No. SOP/Ointment/023 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…
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SOP for Conducting Exploratory Toxicology Studies Standard Operating Procedure (SOP) for Conducting Exploratory Toxicology Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting exploratory toxicology studies. These studies aim to evaluate the potential toxic effects of a drug candidate in an early stage of development. Exploratory…
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SOP for Conducting Emergency Shutdown of Equipment Standard Operating Procedure for Conducting Emergency Shutdown of Equipment 1) Purpose The purpose of this SOP is to provide a structured procedure for safely and efficiently shutting down equipment during emergencies to protect personnel, prevent damage, and mitigate risks to the facility and environment. 2) Scope This SOP…
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Tablets: SOP for End-Point Determination in Granulation Process – V 2.0 Standard Operating Procedure for End-Point Determination in Granulation Process Department Tablet SOP No. SOP/TAB/023/2025 Supersedes SOP/TAB/023/2022 Page No. Page 1 of 7 Issue Date 03/06/2025 Effective Date 08/06/2025 Review Date 03/06/2026 1. Purpose This SOP defines the procedures for determining the end-point in the…
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SOP for Responding to Hazardous Material Exposure Incidents Standard Operating Procedure for Responding to Hazardous Material Exposure Incidents 1) Purpose The purpose of this SOP is to establish clear guidelines for managing hazardous material exposure incidents, minimizing health risks, and ensuring timely and effective medical intervention for affected personnel. 2) Scope This SOP applies to…
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