Author: Auditor

Ointments: SOP for Documentation of Packed Batches – V 2.0

SOP for Documentation of Packed Batches – V 2.0 Procedure for Documentation of Packed Batches Department Packaging/Quality Assurance (QA)/Production SOP No. SOP/Ointment/099 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 Operating Procedure…

Ointments V 2.0

Job Safety Analysis for Tablet Deduster

Job Safety Analysis for Tablet Deduster JSA for Safe Operation of Tablet Deduster JSA Number JSA/OralDosage/022/2025 Department Oral Dosage Revision Number V 1.0 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 05/02/2026 1. Purpose The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Tablet Deduster. This…

Oral Dosage Forms (Tablets & Capsules)

SOP for Sampling of Solvents and Flammable Raw Materials in Quarantine – V 2.0

SOP for Sampling of Solvents and Flammable Raw Materials in Quarantine – V 2.0 Standard Operating Procedure for Sampling of Solvents and Flammable Raw Materials in Quarantine Department Quality Control / Quality Assurance / Warehouse SOP No. SOP/RM/083/2025 Supersedes SOP/RM/083/2022 Page No. Page 1 of 15 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026…

Raw Material Warehouse V 2.0

Ointments: SOP for Visual Inspection During Packing – V 2.0

SOP for Visual Inspection During Packing – V 2.0 Procedure for Visual Inspection During Packing Department Packaging/Quality Assurance (QA)/Production SOP No. SOP/Ointment/098 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 Operating Procedure…

Ointments V 2.0

Aerosol: SOP for Continuous Agitation of Suspension Formulations – V 2.0

Aerosol: SOP for Continuous Agitation of Suspension Formulations – V 2.0 SOP for Continuous Agitation of Suspension Formulations Department Aerosol SOP No. SOP/Aerosol/027/2025 Supersedes SOP/Aerosol/027/2022 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 maintaining continuous agitation of…

Aerosols V 2.0

SOP for Identifying and Mitigating Manufacturing Risks

SOP for Identifying and Mitigating Manufacturing Risks Comprehensive Guide to Identifying and Mitigating Manufacturing Risks in Medical Device Production 1) Purpose The purpose of this SOP is to outline a systematic approach for identifying, assessing, and mitigating risks in the manufacturing process of medical devices. This ensures compliance with regulatory standards, maintains product quality, and…

Medical Devices

Job Safety Analysis for Dust Extractor

Job Safety Analysis for Dust Extractor JSA for Safe Operation of Dust Extractor JSA Number JSA/OralDosage/021/2025 Department Oral Dosage Revision Number V 1.0 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 05/02/2026 1. Purpose The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Dust Extractor. This…

Oral Dosage Forms (Tablets & Capsules)

SOP for Quarantine Procedures for Raw Materials Requiring Special Handling – V 2.0

SOP for Quarantine Procedures for Raw Materials Requiring Special Handling – V 2.0 Standard Operating Procedure for Quarantine Procedures for Raw Materials Requiring Special Handling Department Quality Control / Quality Assurance / Warehouse SOP No. SOP/RM/082/2025 Supersedes SOP/RM/082/2022 Page No. Page 1 of 15 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose…

Raw Material Warehouse V 2.0

Ointments: SOP for Barcoding and Serialization in Packaging – V 2.0

SOP for Barcoding and Serialization in Packaging – V 2.0 Procedure for Barcoding and Serialization in Packaging Department Packaging/Quality Assurance (QA)/Production SOP No. SOP/Ointment/097 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

Aerosol: SOP for Quality Check During Propellant Filling – V 2.0

Aerosol: SOP for Quality Check During Propellant Filling – V 2.0 SOP for Quality Check During Propellant Filling Department Aerosol SOP No. SOP/Aerosol/026/2025 Supersedes SOP/Aerosol/026/2022 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 conducting quality checks during…

Aerosols V 2.0