Author: Auditor

SOP for Handling and Storage of Temperature-Sensitive Raw Materials – V 2.0

SOP for Handling and Storage of Temperature-Sensitive Raw Materials – V 2.0 Standard Operating Procedure for Handling and Storage of Temperature-Sensitive Raw Materials Department Warehouse / Quality Assurance SOP No. SOP/RM/108/2025 Supersedes SOP/RM/108/2022 Page No. Page 1 of 15 Issue Date 08/02/2025 Effective Date 12/02/2025 Review Date 08/02/2026 1. Purpose This Standard Operating Procedure (SOP)…

Raw Material Warehouse V 2.0

Ointments: SOP for Performing Rinse Sampling for Validation – V 2.0

SOP for Performing Rinse Sampling for Validation – V 2.0 Procedure for Performing Rinse Sampling for Validation Department Quality Assurance (QA)/Validation/Quality Control (QC)/Production SOP No. SOP/Ointment/129 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

Capsule: SOP for Developing Moisture Barrier Coatings for Capsules – V 2.0

Capsule: SOP for Developing Moisture Barrier Coatings for Capsules – V 2.0 Standard Operating Procedure for Developing Moisture Barrier Coatings for Capsules Department Capsule Manufacturing SOP No. SOP/CM/042/2025 Supersedes SOP/CM/042/2022 Page No. Page 1 of 7 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…

Capsules V 2.0

Creams: SOP for Line Clearance in Dispensing Areas – V 2.0

Creams: SOP for Line Clearance in Dispensing Areas – V 2.0 Standard Operating Procedure for Line Clearance in Dispensing Areas Department Creams SOP No. SOP/CRM/018/2025 Supersedes SOP/CRM/018/2022 Page No. Page 1 of 5 Issue Date 25/05/2025 Effective Date 30/05/2025 Review Date 25/05/2026 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to define…

Creams V 2.0

Tablets: SOP for Temperature and Humidity Control in Coating Areas – V 2.0

Tablets: SOP for Temperature and Humidity Control in Coating Areas – V 2.0 Standard Operating Procedure for Temperature and Humidity Control in Coating Areas Department Quality Control SOP No. SOP/TAB/128/2025 Supersedes SOP/TAB/128/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To define the procedure for controlling…

Tablet Manufacturing V2.0

Job Safety Analysis for Capsule Printing Machine

Job Safety Analysis for Capsule Printing Machine JSA for Safe Operation of Capsule Printing Machine JSA Number JSA/OralDosage/047/2025 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 Capsule…

Oral Dosage Forms (Tablets & Capsules)

Capsule: SOP for Process Optimization of Capsule Sealing – V 2.0

Capsule: SOP for Process Optimization of Capsule Sealing – V 2.0 Standard Operating Procedure for Process Optimization of Capsule Sealing Department Capsule Manufacturing SOP No. SOP/CM/041/2025 Supersedes SOP/CM/041/2022 Page No. Page 1 of 7 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to define the procedure…

Capsules V 2.0

Ointments: SOP for Documentation of Cleaning Validation – V 2.0

SOP for Documentation of Cleaning Validation – V 2.0 Procedure for Documentation of Cleaning Validation Department Quality Assurance (QA)/Validation/Quality Control (QC)/Production SOP No. SOP/Ointment/128 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 Storing Excipients Based on Pharmacopoeial Guidelines – V 2.0

SOP for Storing Excipients Based on Pharmacopoeial Guidelines – V 2.0 Standard Operating Procedure for Storing Excipients Based on Pharmacopoeial Guidelines Department Warehouse / Quality Assurance SOP No. SOP/RM/107/2025 Supersedes SOP/RM/107/2022 Page No. Page 1 of 15 Issue Date 07/02/2025 Effective Date 11/02/2025 Review Date 07/02/2026 1. Purpose This Standard Operating Procedure (SOP) outlines the…

Raw Material Warehouse V 2.0

Capsule: SOP for Encapsulation Trials Using New Fill Materials – V 2.0

Capsule: SOP for Encapsulation Trials Using New Fill Materials – V 2.0 Standard Operating Procedure for Encapsulation Trials Using New Fill Materials Department Capsule Manufacturing SOP No. SOP/CM/040/2025 Supersedes SOP/CM/040/2022 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 to define…

Capsules V 2.0