Author: Auditor

API Manufacturing: SOP for Raw Material Sampling Procedure – V 2.0

API Manufacturing: SOP for Raw Material Sampling Procedure – V 2.0 Standard Operating Procedure for Raw Material Sampling Procedure in API Manufacturing Department API Manufacturing SOP No. SOP/API/003/2025 Supersedes SOP/API/003/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To describe the procedure for sampling of raw…

API Manufacturing V 2.0

Aerosol: SOP for Selecting Packaging Materials for Stability Studies – V 2.0

Aerosol: SOP for Selecting Packaging Materials for Stability Studies – V 2.0 SOP for Selecting Packaging Materials for Stability Studies Department Aerosol SOP No. SOP/Aerosol/104/2025 Supersedes SOP/Aerosol/104/2022 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 selecting packaging…

Aerosols V 2.0

SOP for Verification of Storage Conditions During Warehouse Inspections – V 2.0

SOP for Verification of Storage Conditions During Warehouse Inspections – V 2.0 Standard Operating Procedure for Verification of Storage Conditions During Warehouse Inspections Department Warehouse / Quality Assurance SOP No. SOP/RM/174/2025 Supersedes SOP/RM/174/2022 Page No. Page 1 of 15 Issue Date 09/04/2025 Effective Date 16/04/2025 Review Date 09/04/2026 1. Purpose This Standard Operating Procedure (SOP)…

Raw Material Warehouse V 2.0

BA-BE Studies: SOP for Preparing Clinical Investigator’s Brochure (CIB) – V 2.0

BA-BE Studies: SOP for Preparing Clinical Investigator’s Brochure (CIB) – V 2.0 Standard Operating Procedure for Preparing Clinical Investigator’s Brochure (CIB) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/030/2025 Supersedes SOP/BA-BE/030/2022 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 a standardized procedure for…

BA-BE Studies V 2.0

Capsule: SOP for Conducting Long-Term Stability Studies for Capsules – V 2.0

Capsule: SOP for Conducting Long-Term Stability Studies for Capsules – V 2.0 Standard Operating Procedure for Conducting Long-Term Stability Studies for Capsules Department Quality Control SOP No. SOP/QC/211/2025 Supersedes SOP/QC/211/2022 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 define…

Capsules V 2.0

Creams: SOP for Operating Automatic Labeling Machines – V 2.0

Creams: SOP for Operating Automatic Labeling Machines – V 2.0 Standard Operating Procedure for Operating Automatic Labeling Machines Department Creams SOP No. SOP/CRM/089/2025 Supersedes SOP/CRM/089/2022 Page No. Page 1 of 5 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose The purpose of this SOP is to define the procedure for operating automatic…

Creams V 2.0

API Manufacturing: SOP for Receiving and Inspection of Raw Materials – V 2.0

API Manufacturing: SOP for Receiving and Inspection of Raw Materials – V 2.0 Standard Operating Procedure for Receiving and Inspection of Raw Materials in API Manufacturing Department API Manufacturing SOP No. SOP/API/002/2025 Supersedes SOP/API/002/2022 Page No. Page 1 of 11 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To outline a standardized…

API Manufacturing V 2.0

Tablets: SOP for Final Batch Release Authorization – V 2.0

Tablets: SOP for Final Batch Release Authorization – V 2.0 Standard Operating Procedure for Final Batch Release Authorization Department Tablet SOP No. SOP/TAB/215/2025 Supersedes SOP/TAB/215/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose The purpose of this SOP is to define the process for the final…

Tablet Manufacturing V2.0

Capsule: SOP for Handling and Storing Packed Capsules – V 2.0

Capsule: SOP for Handling and Storing Packed Capsules – V 2.0 Standard Operating Procedure for Handling and Storing Packed Capsules Department Capsule Packaging SOP No. SOP/CP/210/2025 Supersedes SOP/CP/210/2022 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 provide guidelines for…

Capsules V 2.0

BA-BE Studies: SOP for Risk Assessment of Study Protocol in BA/BE Studies – V 2.0

BA-BE Studies: SOP for Risk Assessment of Study Protocol in BA/BE Studies – V 2.0 Standard Operating Procedure for Risk Assessment of Study Protocol in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/029/2025 Supersedes SOP/BA-BE/029/2022 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…

BA-BE Studies V 2.0