Author: Auditor

SOP for Regular Preventive Maintenance of Storage Equipment – V 2.0

SOP for Regular Preventive Maintenance of Storage Equipment – V 2.0 Standard Operating Procedure for Regular Preventive Maintenance of Storage Equipment Department Warehouse / Maintenance / Quality Assurance SOP No. SOP/RM/165/2025 Supersedes SOP/RM/165/2022 Page No. Page 1 of 15 Issue Date 02/04/2025 Effective Date 09/04/2025 Review Date 02/04/2026 1. Purpose This Standard Operating Procedure (SOP)…

Raw Material Warehouse V 2.0

Capsule: SOP for Validation of Analytical Methods for Capsules – V 2.0

Capsule: SOP for Validation of Analytical Methods for Capsules – V 2.0 Standard Operating Procedure for Validation of Analytical Methods for Capsules Department Capsule Manufacturing SOP No. SOP/CM/176/2025 Supersedes SOP/CM/176/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to establish…

Capsules V 2.0

BA-BE Studies: SOP for Designing Clinical Study Protocol for BA/BE – V 2.0

BA-BE Studies: SOP for Designing Clinical Study Protocol for BA/BE – V 2.0 Standard Operating Procedure for Designing Clinical Study Protocol for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/003/2025 Supersedes SOP/BA-BE/003/2022 Page No. Page 1 of 14 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a structured approach for…

BA-BE Studies V 2.0

Ointments: SOP for Incorporating Temperature-Sensitive Ingredients – V 2.0

SOP for Incorporating Temperature-Sensitive Ingredients – V 2.0 Procedure for Incorporating Temperature-Sensitive Ingredients Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D) SOP No. SOP/Ointment/194 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…

Ointments V 2.0

Tablets: SOP for Material Dispensing and Reconciliation in QA – V 2.0

Tablets: SOP for Material Dispensing and Reconciliation in QA – V 2.0 Standard Operating Procedure for Material Dispensing and Reconciliation in QA Department Tablet SOP No. SOP/TAB/197/2025 Supersedes SOP/TAB/197/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To establish the procedure for dispensing raw materials for…

Tablet Manufacturing V2.0

Capsule: SOP for Validation of Dust Extraction Systems in Capsule Facilities – V 2.0

Capsule: SOP for Validation of Dust Extraction Systems in Capsule Facilities – V 2.0 Standard Operating Procedure for Validation of Dust Extraction Systems in Capsule Facilities Department Capsule Manufacturing SOP No. SOP/CM/175/2025 Supersedes SOP/CM/175/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this…

Capsules V 2.0

BA-BE Studies: SOP for Reviewing Reference Product Literature – V 2.0

BA-BE Studies: SOP for Reviewing Reference Product Literature – V 2.0 Standard Operating Procedure for Reviewing Reference Product Literature in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/002/2025 Supersedes SOP/BA-BE/002/2022 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 identifying, retrieving, and…

BA-BE Studies V 2.0

Creams: SOP for Stirring Techniques in Cream Manufacturing – V 2.0

Creams: SOP for Stirring Techniques in Cream Manufacturing – V 2.0 Standard Operating Procedure for Stirring Techniques in Cream Manufacturing Department Creams SOP No. SOP/CRM/073/2025 Supersedes SOP/CRM/073/2022 Page No. Page 1 of 6 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose This SOP describes the proper stirring techniques for cream manufacturing. It…

Creams V 2.0

Capsule: SOP for Validation of Dehumidifiers in Capsule Manufacturing Areas – V 2.0

Capsule: SOP for Validation of Dehumidifiers in Capsule Manufacturing Areas – V 2.0 Standard Operating Procedure for Validation of Dehumidifiers in Capsule Manufacturing Areas Department Capsule Manufacturing SOP No. SOP/CM/174/2025 Supersedes SOP/CM/174/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is…

Capsules V 2.0

SOP for Handling and Storing Raw Materials in Open Shelving Systems – V 2.0

SOP for Handling and Storing Raw Materials in Open Shelving Systems – V 2.0 Standard Operating Procedure for Handling and Storing Raw Materials in Open Shelving Systems Department Warehouse / Quality Assurance SOP No. SOP/RM/164/2025 Supersedes SOP/RM/164/2022 Page No. Page 1 of 14 Issue Date 01/04/2025 Effective Date 08/04/2025 Review Date 01/04/2026 1. Purpose This…

Raw Material Warehouse V 2.0