Author: Auditor

Ointments: SOP for Handling Interruptions During Ointment Manufacturing – V 2.0

SOP for Handling Interruptions During Ointment Manufacturing – V 2.0 Procedure for Handling Interruptions During Ointment Manufacturing Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Engineering SOP No. SOP/Ointment/199 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…

Ointments V 2.0

BA-BE Studies: SOP for Preparation of Dossiers for US FDA ANDA Submissions – V 2.0

BA-BE Studies: SOP for Preparation of Dossiers for US FDA ANDA Submissions – V 2.0 Standard Operating Procedure for Preparation of Dossiers for US FDA ANDA Submissions Department BA-BE Studies SOP No. SOP/BA-BE/010/2025 Supersedes SOP/BA-BE/010/2022 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…

BA-BE Studies V 2.0

SOP for Storage of Liquid Raw Materials in Compliance with GMP – V 2.0

SOP for Storage of Liquid Raw Materials in Compliance with GMP – V 2.0 Standard Operating Procedure for Storage of Liquid Raw Materials in Compliance with GMP Department Warehouse / Quality Assurance / Production SOP No. SOP/RM/169/2025 Supersedes SOP/RM/169/2022 Page No. Page 1 of 15 Issue Date 04/04/2025 Effective Date 11/04/2025 Review Date 04/04/2026 1….

Raw Material Warehouse V 2.0

Tablets: SOP for Reviewing In-Process Quality Control Results – V 2.0

Tablets: SOP for Reviewing In-Process Quality Control Results – V 2.0 Standard Operating Procedure for Reviewing In-Process Quality Control Results Department Tablet SOP No. SOP/TAB/202/2025 Supersedes SOP/TAB/202/2022 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 reviewing in-process quality control (IPQC) results…

Tablet Manufacturing V2.0

Capsule: SOP for Microbial Limit Testing for Capsules – V 2.0

Capsule: SOP for Microbial Limit Testing for Capsules – V 2.0 Standard Operating Procedure for Microbial Limit Testing for Capsules Department Capsule Manufacturing SOP No. SOP/CM/185/2025 Supersedes SOP/CM/185/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP defines the procedure for conducting microbial limit testing…

Capsules V 2.0

BA-BE Studies: SOP for Filing Form 44 to CDSCO for BA/BE Studies – V 2.0

BA-BE Studies: SOP for Filing Form 44 to CDSCO for BA/BE Studies – V 2.0 Standard Operating Procedure for Filing Form 44 to CDSCO for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/009/2025 Supersedes SOP/BA-BE/009/2022 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

Capsule: SOP for Assay Testing of Capsule Fill Materials – V 2.0

Capsule: SOP for Assay Testing of Capsule Fill Materials – V 2.0 Standard Operating Procedure for Assay Testing of Capsule Fill Materials Department Capsule Manufacturing SOP No. SOP/CM/184/2025 Supersedes SOP/CM/184/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose To outline the procedure for performing assay testing…

Capsules V 2.0

Creams: SOP for Process Optimization in Cream Manufacturing – V 2.0

Creams: SOP for Process Optimization in Cream Manufacturing – V 2.0 Standard Operating Procedure for Process Optimization in Cream Manufacturing Department Creams SOP No. SOP/CRM/077/2025 Supersedes SOP/CRM/077/2022 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 outlines the process optimization strategies in cream manufacturing. The…

Creams V 2.0

Ointments: SOP for Monitoring Real-Time Process Parameters – V 2.0

SOP for Monitoring Real-Time Process Parameters – V 2.0 Procedure for Monitoring Real-Time Process Parameters Department Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Engineering SOP No. SOP/Ointment/198 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 Standard…

Ointments V 2.0

SOP for Ensuring Proper Air Circulation in Raw Material Storage Areas – V 2.0

SOP for Ensuring Proper Air Circulation in Raw Material Storage Areas – V 2.0 Standard Operating Procedure for Ensuring Proper Air Circulation in Raw Material Storage Areas Department Warehouse / Quality Assurance / Maintenance SOP No. SOP/RM/168/2025 Supersedes SOP/RM/168/2022 Page No. Page 1 of 14 Issue Date 03/04/2025 Effective Date 10/04/2025 Review Date 03/04/2026 1….

Raw Material Warehouse V 2.0