Author: Auditor

SOP for Use of ‘Under Test’ Labels on Quarantined Materials – V 2.0

SOP for Use of ‘Under Test’ Labels on Quarantined Materials – V 2.0 Standard Operating Procedure for Use of ‘Under Test’ Labels on Quarantined Materials Department Warehouse / Quality Assurance / Quality Control SOP No. SOP/RM/063/2025 Supersedes SOP/RM/063/2022 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

SOP for Selection of Solubilizers for Poorly Soluble Drugs

SOP for Selection of Solubilizers for Poorly Soluble Drugs Standard Operating Procedure (SOP) for Selection of Solubilizers for Poorly Soluble Drugs 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for selecting appropriate solubilizers for poorly soluble drugs in pharmaceutical formulations. Poor solubility is a common challenge in drug…

Drug Discovery

Ointments: SOP for Checking the Homogeneity of Ointment Batches – V 2.0

SOP for Checking the Homogeneity of Ointment Batches – V 2.0 Procedure for Checking the Homogeneity of Ointment Batches Department Production/Quality Control (QC)/Quality Assurance (QA) SOP No. SOP/Ointment/075 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…

Ointments V 2.0

Tablets: SOP for Disintegration Testing for Immediate Release Tablets – V 2.0

Tablets: SOP for Disintegration Testing for Immediate Release Tablets – V 2.0 Standard Operating Procedure for Disintegration Testing for Immediate Release Tablets Department Tablet SOP No. SOP/TAB/075/2025 Supersedes SOP/TAB/075/2022 Page No. Page 1 of 6 Issue Date 25/02/2026 Effective Date 01/03/2026 Review Date 25/02/2027 1. Purpose To outline the procedure for performing disintegration testing of…

Tablet Manufacturing V2.0

Job Safety Analysis for High Shear Mixer

Job Safety Analysis for High Shear Mixer JSA for Safe Operation of High Shear Mixer JSA Number JSA/OralDosage/003/2025 Department Oral Dosage Revision Number V 1.0 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 05/02/2026 1. Purpose The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the High…

Oral Dosage Forms (Tablets & Capsules)

Aerosol: SOP for Selecting Propellants for Aerosol Dosage Forms – V 2.0

Aerosol: SOP for Selecting Propellants for Aerosol Dosage Forms – V 2.0 SOP for Selecting Propellants for Aerosol Dosage Forms Department Aerosol SOP No. SOP/Aerosol/012/2025 Supersedes SOP/Aerosol/012/2022 Page No. Page 1 of Y Issue Date 06/02/2025 Effective Date 16/02/2025 Review Date 06/02/2028 1. Purpose This Standard Operating Procedure (SOP) outlines the procedure for selecting propellants…

Aerosols V 2.0

SOP for Transporting Raw Materials from Receiving Area to Quarantine – V 2.0

SOP for Transporting Raw Materials from Receiving Area to Quarantine – V 2.0 Standard Operating Procedure for Transporting Raw Materials from Receiving Area to Quarantine Department Warehouse / Quality Assurance / Logistics SOP No. SOP/RM/062/2025 Supersedes SOP/RM/062/2022 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 Dissolution Profile Comparison in Formulation Screening

SOP for Dissolution Profile Comparison in Formulation Screening Standard Operating Procedure (SOP) for Dissolution Profile Comparison in Formulation Screening 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for comparing dissolution profiles of different pharmaceutical formulations during screening. Dissolution testing is an essential tool in the development of oral…

Drug Discovery

Ointments: SOP for Ensuring Batch Uniformity in Ointments – V 2.0

SOP for Ensuring Batch Uniformity in Ointments – V 2.0 Procedure for Ensuring Batch Uniformity in Ointments Department Production/Quality Control (QC)/Quality Assurance (QA) SOP No. SOP/Ointment/074 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

Tablets: SOP for Uniformity of Dosage Units Testing in Tablets – V 2.0

Tablets: SOP for Uniformity of Dosage Units Testing in Tablets – V 2.0 Standard Operating Procedure for Uniformity of Dosage Units Testing in Tablets Department Tablet SOP No. SOP/TAB/074/2025 Supersedes SOP/TAB/074/2022 Page No. Page 1 of 6 Issue Date 20/02/2026 Effective Date 25/02/2026 Review Date 20/02/2027 1. Purpose To provide a standardized procedure for testing…

Tablet Manufacturing V2.0