Author: Auditor

Capsule: SOP for Validation of Granulation Processes for Capsules – V 2.0

Capsule: SOP for Validation of Granulation Processes for Capsules – V 2.0 Standard Operating Procedure for Validation of Granulation Processes for Capsules Department Capsule Manufacturing SOP No. SOP/CM/178/2025 Supersedes SOP/CM/178/2022 Page No. Page 1 of 10 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

Ointments: SOP for Ensuring Proper Dispersion of Active Ingredients – V 2.0

SOP for Ensuring Proper Dispersion of Active Ingredients – V 2.0 Procedure for Ensuring Proper Dispersion of Active Ingredients Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D) SOP No. SOP/Ointment/195 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]…

Ointments V 2.0

Tablets: SOP for Ensuring Compliance with Regulatory Guidelines – V 2.0

Tablets: SOP for Ensuring Compliance with Regulatory Guidelines – V 2.0 Standard Operating Procedure for Ensuring Compliance with Regulatory Guidelines Department Tablet SOP No. SOP/TAB/198/2025 Supersedes SOP/TAB/198/2022 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 procedures for ensuring compliance with regulatory guidelines and ensuring…

Tablet Manufacturing V2.0

BA-BE Studies: SOP for Selecting Bioequivalence Study Design (Crossover, Parallel, etc.) – V 2.0

BA-BE Studies: SOP for Selecting Bioequivalence Study Design (Crossover, Parallel, etc.) – V 2.0 Standard Operating Procedure for Selecting Bioequivalence Study Design in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/004/2025 Supersedes SOP/BA-BE/004/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To outline the procedure for…

BA-BE Studies V 2.0

Capsule: SOP for Validation of Stability Studies for Capsules – V 2.0

Capsule: SOP for Validation of Stability Studies for Capsules – V 2.0 Standard Operating Procedure for Validation of Stability Studies for Capsules Department Capsule Manufacturing SOP No. SOP/CM/177/2025 Supersedes SOP/CM/177/2022 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

Aerosol: SOP for Labeling Aerosol Cans Post-Manufacturing – V 2.0

Aerosol: SOP for Labeling Aerosol Cans Post-Manufacturing – V 2.0 SOP for Labeling Aerosol Cans Post-Manufacturing Department Aerosol SOP No. SOP/Aerosol/092/2025 Supersedes SOP/Aerosol/092/2022 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 labeling aerosol cans after manufacturing to…

Aerosols V 2.0

Creams: SOP for Quality-by-Design (QbD) in Cream Production – V 2.0

Creams: SOP for Quality-by-Design (QbD) in Cream Production – V 2.0 Standard Operating Procedure for Quality-by-Design (QbD) in Cream Production Department Creams SOP No. SOP/CRM/074/2025 Supersedes SOP/CRM/074/2022 Page No. Page 1 of 6 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose The purpose of this SOP is to implement Quality-by-Design (QbD) principles…

Creams V 2.0

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