Author: Auditor

Tablets: SOP for High Shear Granulation Process Optimization – V 2.0

Tablets: SOP for High Shear Granulation Process Optimization – V 2.0 Standard Operating Procedure for High Shear Granulation Process Optimization Department Tablet SOP No. SOP/TAB/051/2025 Supersedes SOP/TAB/051/2022 Page No. Page 1 of 8 Issue Date 26/10/2025 Effective Date 31/10/2025 Review Date 26/10/2026 1. Purpose This Standard Operating Procedure (SOP) outlines the procedure for optimizing the…

Tablet Manufacturing V2.0

Ointments: SOP for Operating a Deaerator in Ointment Manufacturing – V 2.0

SOP for Operating a Deaerator in Ointment Manufacturing – V 2.0 Procedure for Operating a Deaerator in Ointment Manufacturing Department Production/Engineering/Quality Assurance (QA) SOP No. SOP/Ointment/050 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…

Ointments V 2.0

SOP for Screening Polymorphs of APIs

SOP for Screening Polymorphs of APIs Standard Operating Procedure (SOP) for Screening Polymorphs of APIs 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening polymorphs of Active Pharmaceutical Ingredients (APIs) during the drug development process. Polymorphism can significantly influence the solubility, bioavailability, stability, and processing characteristics of…

Drug Discovery

Tablets: SOP for Setup and Validation of Semi-Automatic Tablet Press – V 2.0

Tablets: SOP for Setup and Validation of Semi-Automatic Tablet Press – V 2.0 Standard Operating Procedure for Setup and Validation of Semi-Automatic Tablet Press Department Tablet SOP No. SOP/TAB/050/2025 Supersedes SOP/TAB/050/2022 Page No. Page 1 of 7 Issue Date 21/10/2025 Effective Date 26/10/2025 Review Date 21/10/2026 1. Purpose The purpose of this Standard Operating Procedure…

Tablet Manufacturing V2.0

SOP for Handling and Storing Documents Related to Raw Material Receiving – V 2.0

SOP for Handling and Storing Documents Related to Raw Material Receiving – V 2.0 Standard Operating Procedure for Handling and Storing Documents Related to Raw Material Receiving Department Warehouse / Quality Assurance / Procurement SOP No. SOP/RM/041/2025 Supersedes SOP/RM/041/2022 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

Ointments: SOP for Handling Emergency Stops in Machines – V 2.0

SOP for Handling Emergency Stops in Machines – V 2.0 Procedure for Handling Emergency Stops in Machines Department Production/Engineering/Quality Assurance (QA)/Safety SOP No. SOP/Ointment/049 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 Solid Dispersion Screening Methods

SOP for Solid Dispersion Screening Methods Standard Operating Procedure (SOP) for Solid Dispersion Screening Methods 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening solid dispersion methods in the formulation of drug candidates. Solid dispersions are a promising strategy to enhance the solubility and bioavailability of poorly…

Drug Discovery

Tablets: SOP for Preventive Maintenance of Tablet Manufacturing Equipment – V 2.0

Tablets: SOP for Preventive Maintenance of Tablet Manufacturing Equipment – V 2.0 Standard Operating Procedure for Preventive Maintenance of Tablet Manufacturing Equipment Department Tablet SOP No. SOP/TAB/049/2025 Supersedes SOP/TAB/049/2022 Page No. Page 1 of 6 Issue Date 16/10/2025 Effective Date 21/10/2025 Review Date 16/10/2026 1. Purpose This Standard Operating Procedure (SOP) defines the preventive maintenance…

Tablet Manufacturing V2.0

SOP for Cross-Verification of Vendor Details in Material Receipt Logs – V 2.0

SOP for Cross-Verification of Vendor Details in Material Receipt Logs – V 2.0 Standard Operating Procedure for Cross-Verification of Vendor Details in Material Receipt Logs Department Warehouse / Quality Assurance / Procurement SOP No. SOP/RM/040/2025 Supersedes SOP/RM/040/2022 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 High-Throughput Formulation Screening Techniques

SOP for High-Throughput Formulation Screening Techniques Standard Operating Procedure (SOP) for High-Throughput Formulation Screening Techniques 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for utilizing high-throughput formulation screening (HTFS) techniques in pharmaceutical formulation development. HTFS techniques are designed to rapidly evaluate and optimize multiple formulation parameters simultaneously, significantly…

Drug Discovery