Author: Auditor

BA-BE Studies: SOP for Developing Informed Consent Documents – V 2.0

BA-BE Studies: SOP for Developing Informed Consent Documents – V 2.0 Standard Operating Procedure for Developing Informed Consent Documents in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/022/2025 Supersedes SOP/BA-BE/022/2022 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 process for developing, reviewing, and…

BA-BE Studies V 2.0

Aerosol: SOP for Documentation of Packaging Operations – V 2.0

Aerosol: SOP for Documentation of Packaging Operations – V 2.0 SOP for Documentation of Packaging Operations Department Aerosol SOP No. SOP/Aerosol/100/2025 Supersedes SOP/Aerosol/100/2022 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 documenting packaging operations to ensure complete…

Aerosols V 2.0

Creams: SOP for Calibrating Temperature Sensors in Manufacturing Equipment – V 2.0

Creams: SOP for Calibrating Temperature Sensors in Manufacturing Equipment – V 2.0 Standard Operating Procedure for Calibrating Temperature Sensors in Manufacturing Equipment Department Creams SOP No. SOP/CRM/084/2025 Supersedes SOP/CRM/084/2022 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 outline the…

Creams V 2.0

BA-BE Studies: SOP for Registration of BE Trials on CTRI – V 2.0

BA-BE Studies: SOP for Registration of BE Trials on CTRI – V 2.0 Standard Operating Procedure for Registration of BE Trials on CTRI Department BA-BE Studies SOP No. SOP/BA-BE/021/2025 Supersedes SOP/BA-BE/021/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a standardized procedure for registering…

BA-BE Studies V 2.0

Tablets: SOP for Review of Microbial Testing Reports – V 2.0

Tablets: SOP for Review of Microbial Testing Reports – V 2.0 Standard Operating Procedure for Review of Microbial Testing Reports Department Tablet SOP No. SOP/TAB/210/2025 Supersedes SOP/TAB/210/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose This SOP outlines the procedure for reviewing microbial testing reports in…

Tablet Manufacturing V2.0

Capsule: SOP for Preparation of QC Reports for Capsule Testing – V 2.0

Capsule: SOP for Preparation of QC Reports for Capsule Testing – V 2.0 Standard Operating Procedure for Preparation of QC Reports for Capsule Testing Department Capsule Manufacturing SOP No. SOP/CM/200/2025 Supersedes SOP/CM/200/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP outlines the procedure for…

Capsules V 2.0

BA-BE Studies: SOP for Pre-Submission Meeting with Regulatory Authorities – V 2.0

BA-BE Studies: SOP for Pre-Submission Meeting with Regulatory Authorities – V 2.0 Standard Operating Procedure for Pre-Submission Meeting with Regulatory Authorities in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/020/2025 Supersedes SOP/BA-BE/020/2022 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 a structured procedure for…

BA-BE Studies V 2.0

Capsule: SOP for Environmental Monitoring During Capsule QC – V 2.0

Capsule: SOP for Environmental Monitoring During Capsule QC – V 2.0 Standard Operating Procedure for Environmental Monitoring During Capsule QC Department Capsule Manufacturing SOP No. SOP/CM/199/2025 Supersedes SOP/CM/199/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP provides the procedure for environmental monitoring during the…

Capsules V 2.0

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

Tablets: SOP for Ensuring Compliance with FDA Guidelines – V 2.0 Standard Operating Procedure for Ensuring Compliance with FDA Guidelines Department Tablet SOP No. SOP/TAB/209/2025 Supersedes SOP/TAB/209/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose This SOP outlines the procedure for ensuring compliance with the FDA…

Tablet Manufacturing V2.0

Creams: SOP for Operating Cream-Filling Machines – V 2.0

Creams: SOP for Operating Cream-Filling Machines – V 2.0 Standard Operating Procedure for Operating Cream-Filling Machines Department Creams SOP No. SOP/CRM/083/2025 Supersedes SOP/CRM/083/2022 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 procedure for operating cream-filling machines during the packaging process. The purpose…

Creams V 2.0