Author: Auditor

SOP for Handling and Documenting Storage Deviations and Non-Conformances – V 2.0

SOP for Handling and Documenting Storage Deviations and Non-Conformances – V 2.0 Standard Operating Procedure for Handling and Documenting Storage Deviations and Non-Conformances Department Quality Assurance / Warehouse SOP No. SOP/RM/167/2025 Supersedes SOP/RM/167/2022 Page No. Page 1 of 14 Issue Date 03/04/2025 Effective Date 10/04/2025 Review Date 03/04/2026 1. Purpose This Standard Operating Procedure (SOP)…

Raw Material Warehouse V 2.0

Capsule: SOP for Validation of In-Process Testing for Capsules – V 2.0

Capsule: SOP for Validation of In-Process Testing for Capsules – V 2.0 Standard Operating Procedure for Validation of In-Process Testing for Capsules Department Capsule Manufacturing SOP No. SOP/CM/180/2025 Supersedes SOP/CM/180/2022 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 Fasted vs Fed Study Design Selection – V 2.0

BA-BE Studies: SOP for Fasted vs Fed Study Design Selection – V 2.0 Standard Operating Procedure for Fasted vs Fed Study Design Selection in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/006/2025 Supersedes SOP/BA-BE/006/2022 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 criteria…

BA-BE Studies V 2.0

Aerosol: SOP for Coding and Marking of Aerosol Products – V 2.0

Aerosol: SOP for Coding and Marking of Aerosol Products – V 2.0 SOP for Coding and Marking of Aerosol Products Department Aerosol SOP No. SOP/Aerosol/093/2025 Supersedes SOP/Aerosol/093/2022 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 process for coding and…

Aerosols V 2.0

Ointments: SOP for Preventing Air Entrapment During Mixing – V 2.0

SOP for Preventing Air Entrapment During Mixing – V 2.0 Procedure for Preventing Air Entrapment During Mixing Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D) SOP No. SOP/Ointment/196 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…

Ointments V 2.0

Tablets: SOP for Handling Returned Goods in Tablet Manufacturing – V 2.0

Tablets: SOP for Handling Returned Goods in Tablet Manufacturing – V 2.0 Standard Operating Procedure for Handling Returned Goods in Tablet Manufacturing Department Tablet SOP No. SOP/TAB/199/2025 Supersedes SOP/TAB/199/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To define the procedure for handling returned goods in…

Tablet Manufacturing V2.0

Creams: SOP for End-Point Detection during Cream Mixing – V 2.0

Creams: SOP for End-Point Detection during Cream Mixing – V 2.0 Standard Operating Procedure for End-Point Detection during Cream Mixing Department Creams SOP No. SOP/CRM/075/2025 Supersedes SOP/CRM/075/2022 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 defines the procedure for end-point detection during the mixing…

Creams V 2.0

Capsule: SOP for Validation of Capsule Packing Processes – V 2.0

Capsule: SOP for Validation of Capsule Packing Processes – V 2.0 Standard Operating Procedure for Validation of Capsule Packing Processes Department Capsule Manufacturing SOP No. SOP/CM/179/2025 Supersedes SOP/CM/179/2022 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 define the process…

Capsules V 2.0

BA-BE Studies: SOP for Dose Selection Criteria for BA/BE Studies – V 2.0

BA-BE Studies: SOP for Dose Selection Criteria for BA/BE Studies – V 2.0 Standard Operating Procedure for Dose Selection Criteria in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/005/2025 Supersedes SOP/BA-BE/005/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a standardized process for selecting…

BA-BE Studies V 2.0

SOP for Checking Raw Material Storage Compliance During Audits – V 2.0

SOP for Checking Raw Material Storage Compliance During Audits – V 2.0 Standard Operating Procedure for Checking Raw Material Storage Compliance During Audits Department Quality Assurance / Warehouse SOP No. SOP/RM/166/2025 Supersedes SOP/RM/166/2022 Page No. Page 1 of 14 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