Author: Auditor

Capsule: SOP for Cleaning Blender Machines Used in Capsule Production – V 2.0

Capsule: SOP for Cleaning Blender Machines Used in Capsule Production – V 2.0 Standard Operating Procedure for Cleaning Blender Machines Used in Capsule Production Department Capsule Manufacturing SOP No. SOP/CM/138/2025 Supersedes SOP/CM/138/2022 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…

Capsules V 2.0

SOP for Routine Warehouse Housekeeping and Cleaning Procedures – V 2.0

SOP for Routine Warehouse Housekeeping and Cleaning Procedures – V 2.0 Standard Operating Procedure for Routine Warehouse Housekeeping and Cleaning Procedures Department Warehouse / Quality Assurance / Maintenance SOP No. SOP/RM/148/2025 Supersedes SOP/RM/148/2022 Page No. Page 1 of 15 Issue Date 17/03/2025 Effective Date 24/03/2025 Review Date 17/03/2026 1. Purpose This Standard Operating Procedure (SOP)…

Raw Material Warehouse V 2.0

Tablets: SOP for Vendor Qualification for Raw Materials Used in Tablets – V 2.0

Tablets: SOP for Vendor Qualification for Raw Materials Used in Tablets – V 2.0 Standard Operating Procedure for Vendor Qualification for Raw Materials Used in Tablets Department Tablet SOP No. SOP/TAB/177/2025 Supersedes SOP/TAB/177/2022 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 procedures for…

Tablet Manufacturing V2.0

Capsule: SOP for Cleaning Capsule Size Sorting Machines – V 2.0

Capsule: SOP for Cleaning Capsule Size Sorting Machines – V 2.0 Standard Operating Procedure for Cleaning Capsule Size Sorting Machines Department Capsule Manufacturing SOP No. SOP/CM/137/2025 Supersedes SOP/CM/137/2022 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 outline the cleaning…

Capsules V 2.0

Creams: SOP for Handling Deviations during Manufacturing – V 2.0

Creams: SOP for Handling Deviations during Manufacturing – V 2.0 Standard Operating Procedure for Handling Deviations during Manufacturing Department Creams SOP No. SOP/CRM/058/2025 Supersedes SOP/CRM/058/2022 Page No. Page 1 of 6 Issue Date 12/12/2025 Effective Date 17/12/2025 Review Date 12/12/2026 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to define the steps…

Creams V 2.0

SOP for Managing Device Master Records (DMR)

SOP for Managing Device Master Records (DMR) Comprehensive Guide to Managing Device Master Records (DMR) in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized approach to creating, maintaining, and managing Device Master Records (DMR) for medical devices. The DMR is a comprehensive document that defines the specifications, production…

Medical Devices

Capsule: SOP for Cleaning Equipment Between Soft Gel and Hard Gelatin Batches – V 2.0

Capsule: SOP for Cleaning Equipment Between Soft Gel and Hard Gelatin Batches – V 2.0 Standard Operating Procedure for Cleaning Equipment Between Soft Gel and Hard Gelatin Batches Department Capsule Manufacturing SOP No. SOP/CM/136/2025 Supersedes SOP/CM/136/2022 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…

Capsules V 2.0

Ointments: SOP for Dispensing Colorants and Pigments – V 2.0

SOP for Dispensing Colorants and Pigments – V 2.0 Procedure for Dispensing Colorants and Pigments Department Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse SOP No. SOP/Ointment/174 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 Management of Raw Materials in Overcrowded Warehouses – V 2.0

SOP for Management of Raw Materials in Overcrowded Warehouses – V 2.0 Standard Operating Procedure for Management of Raw Materials in Overcrowded Warehouses Department Warehouse / Quality Assurance / Supply Chain Management SOP No. SOP/RM/147/2025 Supersedes SOP/RM/147/2022 Page No. Page 1 of 15 Issue Date 16/03/2025 Effective Date 23/03/2025 Review Date 16/03/2026 1. Purpose This…

Raw Material Warehouse V 2.0

Untitled

Annexure-5: Cleaning Log Cleaning Date Area Cleaned Cleaning Personnel Cleaning Agent Used Remarks 01/01/2026 Production Area 1 John Doe Disinfectant X Cleaned according to SOP 02/01/2026 Packaging Area Jane Smith Disinfectant Y Minor debris removed Annexure-6: Cleanroom Record Retention Log Document Type Retention Period Storage Location Record Retention End Date Responsible Person Cleanroom Classification Record…