Author: Auditor

Tablets: SOP for Sampling Plan for In-Process Tablet Testing – V 2.0

Tablets: SOP for Sampling Plan for In-Process Tablet Testing – V 2.0 Standard Operating Procedure for Sampling Plan for In-Process Tablet Testing Department Quality Control SOP No. SOP/TAB/130/2025 Supersedes SOP/TAB/130/2022 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 selecting representative tablet…

Tablet Manufacturing V2.0

Capsule: SOP for Validation of Capsule Development Procedures – V 2.0

Capsule: SOP for Validation of Capsule Development Procedures – V 2.0 Standard Operating Procedure for Validation of Capsule Development Procedures Department Capsule Manufacturing SOP No. SOP/CM/045/2025 Supersedes SOP/CM/045/2022 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 establish a systematic…

Capsules V 2.0

SOP for Use of Cold Storage Units for Sensitive Raw Materials – V 2.0

SOP for Use of Cold Storage Units for Sensitive Raw Materials – V 2.0 Standard Operating Procedure for Use of Cold Storage Units for Sensitive Raw Materials Department Warehouse / Quality Assurance SOP No. SOP/RM/109/2025 Supersedes SOP/RM/109/2022 Page No. Page 1 of 15 Issue Date 09/02/2025 Effective Date 13/02/2025 Review Date 09/02/2026 1. Purpose This…

Raw Material Warehouse V 2.0

Creams: SOP for Handling Rejected or Returned Materials in Dispensing – V 2.0

Creams: SOP for Handling Rejected or Returned Materials in Dispensing – V 2.0 Standard Operating Procedure for Handling Rejected or Returned Materials in Dispensing Department Creams SOP No. SOP/CRM/019/2025 Supersedes SOP/CRM/019/2022 Page No. Page 1 of 5 Issue Date 30/05/2025 Effective Date 05/06/2025 Review Date 30/05/2026 1. Purpose The purpose of this Standard Operating Procedure…

Creams V 2.0

Ointments: SOP for Ensuring Validation of All Surfaces – V 2.0

SOP for Ensuring Validation of All Surfaces – V 2.0 Procedure for Ensuring Validation of All Surfaces Department Quality Assurance (QA)/Validation/Quality Control (QC)/Production SOP No. SOP/Ointment/130 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 Formulating High-Potency Drugs in Capsules – V 2.0

Capsule: SOP for Formulating High-Potency Drugs in Capsules – V 2.0 Standard Operating Procedure for Formulating High-Potency Drugs in Capsules Department Capsule Manufacturing SOP No. SOP/CM/044/2025 Supersedes SOP/CM/044/2022 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 establish a consistent…

Capsules V 2.0

Tablets: SOP for Tablet Dedusting Monitoring in Compression Process – V 2.0

Tablets: SOP for Tablet Dedusting Monitoring in Compression Process – V 2.0 Standard Operating Procedure for Tablet Dedusting Monitoring in Compression Process Department Quality Control SOP No. SOP/TAB/129/2025 Supersedes SOP/TAB/129/2022 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 monitoring the tablet…

Tablet Manufacturing V2.0

Job Safety Analysis for High-Speed Capsule Sorter

Job Safety Analysis for High-Speed Capsule Sorter JSA for Safe Operation of High-Speed Capsule Sorter JSA Number JSA/OralDosage/048/2025 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 High-Speed…

Oral Dosage Forms (Tablets & Capsules)

Capsule: SOP for Designing Extended-Release Capsule Formulations – V 2.0

Capsule: SOP for Designing Extended-Release Capsule Formulations – V 2.0 Standard Operating Procedure for Designing Extended-Release Capsule Formulations Department Capsule Manufacturing SOP No. SOP/CM/043/2025 Supersedes SOP/CM/043/2022 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 the procedure for designing…

Capsules V 2.0

Aerosol: SOP for Troubleshooting Aerosol Manufacturing Machines – V 2.0

Aerosol: SOP for Troubleshooting Aerosol Manufacturing Machines – V 2.0 SOP for Troubleshooting Aerosol Manufacturing Machines Department Aerosol SOP No. SOP/Aerosol/047/2025 Supersedes SOP/Aerosol/047/2022 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 procedure for troubleshooting aerosol manufacturing machines. The purpose…

Aerosols V 2.0