Author: Auditor

SOP for Screening Drug Nanoparticles for Solubility Enhancement

SOP for Screening Drug Nanoparticles for Solubility Enhancement Standard Operating Procedure (SOP) for Screening Drug Nanoparticles for Solubility Enhancement 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for screening drug nanoparticles aimed at enhancing the solubility of poorly water-soluble drugs. Nanoparticles can significantly improve the solubility and bioavailability…

Drug Discovery

SOP for Sterilization Process Validation

SOP for Sterilization Process Validation Comprehensive Guide to Sterilization Process Validation in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized process for validating sterilization procedures used in medical device manufacturing. Validation ensures that sterilization processes consistently achieve the required sterility assurance level (SAL) and comply with regulatory and…

Medical Devices

Ointments: SOP for Cleaning Homogenizers – V 2.0

SOP for Cleaning Homogenizers – V 2.0 Procedure for Cleaning Homogenizers Department Production/Engineering/Quality Assurance (QA) SOP No. SOP/Ointment/052 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 to define…

Ointments V 2.0

SOP for Immediate Quarantine of Raw Materials Suspected of Contamination – V 2.0

SOP for Immediate Quarantine of Raw Materials Suspected of Contamination – V 2.0 Standard Operating Procedure for Immediate Quarantine of Raw Materials Suspected of Contamination Department Warehouse / Quality Assurance / Quality Control SOP No. SOP/RM/043/2025 Supersedes SOP/RM/043/2022 Page No. Page 1 of 15 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose…

Raw Material Warehouse V 2.0

Tablets: SOP for Fluidized Bed Granulation Methodology – V 2.0

Tablets: SOP for Fluidized Bed Granulation Methodology – V 2.0 Standard Operating Procedure for Fluidized Bed Granulation Methodology Department Tablet SOP No. SOP/TAB/052/2025 Supersedes SOP/TAB/052/2022 Page No. Page 1 of 8 Issue Date 31/10/2025 Effective Date 05/11/2025 Review Date 31/10/2026 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to define the methodology…

Tablet Manufacturing V2.0

SOP for Screening Lipid-Based Formulations

SOP for Screening Lipid-Based Formulations Standard Operating Procedure (SOP) for Screening Lipid-Based Formulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for screening lipid-based formulations used to enhance the solubility and bioavailability of poorly water-soluble drugs. Lipid-based formulations, such as lipid emulsions, liposomes, and self-emulsifying drug delivery systems…

Drug Discovery

Ointments: SOP for Cleaning Mixing Tanks Post-Manufacturing – V 2.0

SOP for Cleaning Mixing Tanks Post-Manufacturing – V 2.0 Procedure for Cleaning Mixing Tanks Post-Manufacturing Department Production/Engineering/Quality Assurance (QA) SOP No. SOP/Ointment/051 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

SOP for Use of Forklifts and Equipment in Receiving Raw Materials – V 2.0

SOP for Use of Forklifts and Equipment in Receiving Raw Materials – V 2.0 Standard Operating Procedure for Use of Forklifts and Equipment in Receiving Raw Materials Department Warehouse / Logistics / Quality Assurance SOP No. SOP/RM/042/2025 Supersedes SOP/RM/042/2022 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 Screening Lipid-Based Formulations

SOP for Screening Lipid-Based Formulations Standard Operating Procedure (SOP) for Screening Lipid-Based Formulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening lipid-based formulations for the delivery of poorly water-soluble drugs. Lipid-based formulations, such as liposomes, solid lipid nanoparticles (SLNs), and self-emulsifying drug delivery systems (SEDDS), are…

Drug Discovery

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