Author: Auditor

BA-BE Studies: SOP for Maintaining Investigator Site File (ISF) – V 2.0

BA-BE Studies: SOP for Maintaining Investigator Site File (ISF) – V 2.0 Standard Operating Procedure for Maintaining Investigator Site File (ISF) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/026/2025 Supersedes SOP/BA-BE/026/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the standard procedure for…

BA-BE Studies V 2.0

Aerosol: SOP for Long-Term Stability Studies of Aerosol Dosage Forms – V 2.0

Aerosol: SOP for Long-Term Stability Studies of Aerosol Dosage Forms – V 2.0 SOP for Long-Term Stability Studies of Aerosol Dosage Forms Department Aerosol SOP No. SOP/Aerosol/102/2025 Supersedes SOP/Aerosol/102/2022 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) defines the process for…

Aerosols V 2.0

Capsule: SOP for Packaging of Capsules with Desiccants – V 2.0

Capsule: SOP for Packaging of Capsules with Desiccants – V 2.0 Standard Operating Procedure for Packaging of Capsules with Desiccants Department Capsule Packaging SOP No. SOP/CP/205/2025 Supersedes SOP/CP/205/2022 Page No. Page 1 of 6 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to describe the procedure…

Capsules V 2.0

Tablets: SOP for Approval of Packaging Material Specifications – V 2.0

Tablets: SOP for Approval of Packaging Material Specifications – V 2.0 Standard Operating Procedure for Approval of Packaging Material Specifications Department Tablet SOP No. SOP/TAB/213/2025 Supersedes SOP/TAB/213/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose This SOP outlines the procedure for the approval of packaging material…

Tablet Manufacturing V2.0

SOP for Documenting the Movement of Raw Materials Within Storage Areas – V 2.0

SOP for Documenting the Movement of Raw Materials Within Storage Areas – V 2.0 Standard Operating Procedure for Documenting the Movement of Raw Materials Within Storage Areas Department Warehouse / Quality Assurance SOP No. SOP/RM/173/2025 Supersedes SOP/RM/173/2022 Page No. Page 1 of 15 Issue Date 08/04/2025 Effective Date 15/04/2025 Review Date 08/04/2026 1. Purpose This…

Raw Material Warehouse V 2.0

BA-BE Studies: SOP for Archival of Regulatory Correspondence – V 2.0

BA-BE Studies: SOP for Archival of Regulatory Correspondence – V 2.0 Standard Operating Procedure for Archival of Regulatory Correspondence in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/025/2025 Supersedes SOP/BA-BE/025/2022 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 proper documentation, classification,…

BA-BE Studies V 2.0

Capsule: SOP for Visual Inspection of Capsules During Packaging – V 2.0

Capsule: SOP for Visual Inspection of Capsules During Packaging – V 2.0 Standard Operating Procedure for Visual Inspection of Capsules During Packaging Department Capsule Packaging SOP No. SOP/CP/204/2025 Supersedes SOP/CP/204/2022 Page No. Page 1 of 5 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to define…

Capsules V 2.0

SOP for Conducting Internal Quality Audits

SOP for Conducting Internal Quality Audits Comprehensive Guide to Conducting Internal Quality Audits 1) Purpose The purpose of this SOP is to establish a systematic approach to planning, conducting, and documenting internal quality audits. These audits ensure that processes comply with established quality management system standards, regulatory requirements, and organizational policies, and that opportunities for…

Medical Devices

Creams: SOP for Cleaning Homogenizers Post-Production – V 2.0

Creams: SOP for Cleaning Homogenizers Post-Production – V 2.0 Standard Operating Procedure for Cleaning Homogenizers Post-Production Department Creams SOP No. SOP/CRM/086/2025 Supersedes SOP/CRM/086/2022 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 cleaning homogenizers post-production to ensure that they are free…

Creams V 2.0

Capsule: SOP for Labeling Bottled Capsules – V 2.0

Capsule: SOP for Labeling Bottled Capsules – V 2.0 Standard Operating Procedure for Labeling Bottled Capsules Department Capsule Packaging SOP No. SOP/CP/203/2025 Supersedes SOP/CP/203/2022 Page No. Page 1 of 6 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP outlines the procedure for labeling bottled capsules to ensure that all capsules…

Capsules V 2.0