Author: Auditor

Job Safety Analysis for High-Speed Rotary Tablet Press

Job Safety Analysis for High-Speed Rotary Tablet Press JSA for Safe Operation of High-Speed Rotary Tablet Press JSA Number JSA/OralDosage/032/2025 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…

Oral Dosage Forms (Tablets & Capsules)

Capsule: SOP for Handling APIs During Dispensing – V 2.0

Capsule: SOP for Handling APIs During Dispensing – V 2.0 Standard Operating Procedure for Handling APIs During Dispensing Department Capsule Manufacturing SOP No. SOP/CM/004/2025 Supersedes SOP/CM/004/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose To define the procedure for handling Active Pharmaceutical Ingredients (APIs) during dispensing…

Capsules V 2.0

Creams: SOP for Cross-Verification of Weighed Materials – V 2.0

Creams: SOP for Cross-Verification of Weighed Materials – V 2.0 Standard Operating Procedure for Cross-Verification of Weighed Materials Department Creams SOP No. SOP/CRM/003/2025 Supersedes SOP/CRM/003/2022 Page No. Page 1 of 6 Issue Date 10/03/2025 Effective Date 15/03/2025 Review Date 10/03/2026 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure…

Creams V 2.0

Ointments: SOP for Ensuring Compliance with Stability Guidelines – V 2.0

SOP for Ensuring Compliance with Stability Guidelines – V 2.0 Procedure for Ensuring Compliance with Stability Guidelines Department Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs SOP No. SOP/Ointment/109 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…

Ointments V 2.0

SOP for Transporting Rejected Raw Materials from Quarantine to Disposal Area – V 2.0

SOP for Transporting Rejected Raw Materials from Quarantine to Disposal Area – V 2.0 Standard Operating Procedure for Transporting Rejected Raw Materials from Quarantine to Disposal Area Department Quality Assurance / Warehouse / Quality Control SOP No. SOP/RM/092/2025 Supersedes SOP/RM/092/2022 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

Aerosol: SOP for Post-Fill Weight Checks in Aerosol Cans – V 2.0

Aerosol: SOP for Post-Fill Weight Checks in Aerosol Cans – V 2.0 SOP for Post-Fill Weight Checks in Aerosol Cans Department Aerosol SOP No. SOP/Aerosol/034/2025 Supersedes SOP/Aerosol/034/2022 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 conducting post-fill…

Aerosols V 2.0

Capsule: SOP for Labeling and Storage of Dispensed Materials – V 2.0

Capsule: SOP for Labeling and Storage of Dispensed Materials – V 2.0 Standard Operating Procedure for Labeling and Storage of Dispensed Materials Department Capsule Manufacturing SOP No. SOP/CM/003/2025 Supersedes SOP/CM/003/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose To define the procedure for the correct labeling…

Capsules V 2.0

Tablets: SOP for Degradation Product Identification in Tablets – V 2.0

Tablets: SOP for Degradation Product Identification in Tablets – V 2.0 Standard Operating Procedure for Degradation Product Identification in Tablets Department Quality Control SOP No. SOP/TAB/108/2025 Supersedes SOP/TAB/108/2022 Page No. Page 1 of 7 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To define the procedure for identifying degradation products in tablet…

Tablet Manufacturing V2.0

Job Safety Analysis for Bin Blender

Job Safety Analysis for Bin Blender JSA for Safe Operation of Bin Blender JSA Number JSA/OralDosage/031/2025 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 Bin Blender. This…

Oral Dosage Forms (Tablets & Capsules)

Capsule: SOP for Sampling Raw Materials for Quality Testing – V 2.0

Capsule: SOP for Sampling Raw Materials for Quality Testing – V 2.0 Standard Operating Procedure for Sampling Raw Materials for Quality Testing Department Capsule Manufacturing SOP No. SOP/CM/002/2025 Supersedes SOP/CM/002/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose To define the procedure for sampling raw materials…

Capsules V 2.0