Author: Auditor

Aerosol: SOP for Line Clearance Before Packing Operations – V 2.0

Aerosol: SOP for Line Clearance Before Packing Operations – V 2.0 SOP for Line Clearance Before Packing Operations Department Aerosol SOP No. SOP/Aerosol/096/2025 Supersedes SOP/Aerosol/096/2022 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 performing line clearance before…

Aerosols V 2.0

Capsule: SOP for Dissolution Testing of Capsules – V 2.0

Capsule: SOP for Dissolution Testing of Capsules – V 2.0 Standard Operating Procedure for Dissolution Testing of Capsules Department Capsule Manufacturing SOP No. SOP/CM/189/2025 Supersedes SOP/CM/189/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP defines the procedure for performing dissolution testing of capsules to…

Capsules V 2.0

Tablets: SOP for Validating Analytical Methods in QA – V 2.0

Tablets: SOP for Validating Analytical Methods in QA – V 2.0 Standard Operating Procedure for Validating Analytical Methods in QA Department Tablet SOP No. SOP/TAB/204/2025 Supersedes SOP/TAB/204/2022 Page No. Page 1 of 7 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To define the procedure for validating analytical methods used in quality…

Tablet Manufacturing V2.0

Creams: SOP for Disposal of Rejected Batches of Creams – V 2.0

Creams: SOP for Disposal of Rejected Batches of Creams – V 2.0 Standard Operating Procedure for Disposal of Rejected Batches of Creams Department Creams SOP No. SOP/CRM/079/2025 Supersedes SOP/CRM/079/2022 Page No. Page 1 of 5 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose This SOP outlines the procedure for the safe and…

Creams V 2.0

BA-BE Studies: SOP for Handling Expired Reference Products – V 2.0

BA-BE Studies: SOP for Handling Expired Reference Products – V 2.0 Standard Operating Procedure for Handling Expired Reference Products in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/012/2025 Supersedes SOP/BA-BE/012/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for managing expired reference…

BA-BE Studies V 2.0

SOP for Documentation of CAPA in Quality Assurance

SOP for Documentation of CAPA in Quality Assurance Comprehensive Guide to Documentation of CAPA in Quality Assurance 1) Purpose The purpose of this SOP is to establish a standardized process for documenting Corrective and Preventive Actions (CAPA) in quality assurance. Proper documentation ensures traceability, regulatory compliance, and continuous improvement in manufacturing processes and quality systems….

Medical Devices

Capsule: SOP for Disintegration Testing of Soft Gelatin Capsules – V 2.0

Capsule: SOP for Disintegration Testing of Soft Gelatin Capsules – V 2.0 Standard Operating Procedure for Disintegration Testing of Soft Gelatin Capsules Department Capsule Manufacturing SOP No. SOP/CM/188/2025 Supersedes SOP/CM/188/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP outlines the procedure for performing disintegration…

Capsules V 2.0

SOP for Use of Digital Monitoring Systems for Raw Material Storage Conditions – V 2.0

SOP for Use of Digital Monitoring Systems for Raw Material Storage Conditions – V 2.0 Standard Operating Procedure for Use of Digital Monitoring Systems for Raw Material Storage Conditions Department Warehouse / Quality Assurance / IT SOP No. SOP/RM/171/2025 Supersedes SOP/RM/171/2022 Page No. Page 1 of 16 Issue Date 06/04/2025 Effective Date 13/04/2025 Review Date…

Raw Material Warehouse V 2.0

Ointments: SOP for Cleaning and Re-Starting Manufacturing Lines – V 2.0

SOP for Cleaning and Re-Starting Manufacturing Lines – V 2.0 Procedure for Cleaning and Re-Starting Manufacturing Lines Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Engineering SOP No. SOP/Ointment/200 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

Capsule: SOP for Disintegration Testing of Hard Gelatin Capsules – V 2.0

Capsule: SOP for Disintegration Testing of Hard Gelatin Capsules – V 2.0 Standard Operating Procedure for Disintegration Testing of Hard Gelatin Capsules Department Capsule Manufacturing SOP No. SOP/CM/187/2025 Supersedes SOP/CM/187/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP outlines the procedure for performing disintegration…

Capsules V 2.0