Author: Auditor

Capsule: SOP for Monitoring Packaging Line Speeds for Capsules – V 2.0

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Capsule: SOP for Monitoring Packaging Line Speeds for Capsules – V 2.0 Standard Operating Procedure for Monitoring Packaging Line Speeds for Capsules Department Capsule Packaging SOP No. SOP/CP/208/2025 Supersedes SOP/CP/208/2022 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 establish…

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Capsules V 2.0

Capsule: SOP for Packing Capsules in Aluminum Foil – V 2.0

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Capsule: SOP for Packing Capsules in Aluminum Foil – V 2.0 Standard Operating Procedure for Packing Capsules in Aluminum Foil Department Capsule Packaging SOP No. SOP/CP/207/2025 Supersedes SOP/CP/207/2022 Page No. Page 1 of 6 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP defines the procedure for packing capsules into aluminum…

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Capsules V 2.0

BA-BE Studies: SOP for Protocol and SAP (Statistical Analysis Plan) Integration – V 2.0

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BA-BE Studies: SOP for Protocol and SAP (Statistical Analysis Plan) Integration – V 2.0 Standard Operating Procedure for Protocol and SAP (Statistical Analysis Plan) Integration in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/027/2025 Supersedes SOP/BA-BE/027/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define…

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BA-BE Studies V 2.0

Tablets: SOP for Auditing Third-Party Manufacturers of Tablets – V 2.0

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Tablets: SOP for Auditing Third-Party Manufacturers of Tablets – V 2.0 Standard Operating Procedure for Auditing Third-Party Manufacturers of Tablets Department Tablet SOP No. SOP/TAB/214/2025 Supersedes SOP/TAB/214/2022 Page No. Page 1 of 7 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose This SOP provides the procedure for auditing third-party manufacturers of tablets…

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Tablet Manufacturing V2.0

Creams: SOP for Operating Automatic Filling Machines for Creams – V 2.0

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Creams: SOP for Operating Automatic Filling Machines for Creams – V 2.0 Standard Operating Procedure for Operating Automatic Filling Machines for Creams Department Creams SOP No. SOP/CRM/087/2025 Supersedes SOP/CRM/087/2022 Page No. Page 1 of 6 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose The purpose of this SOP is to outline the…

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Creams V 2.0

Capsule: SOP for Primary and Secondary Packaging of Capsules – V 2.0

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Capsule: SOP for Primary and Secondary Packaging of Capsules – V 2.0 Standard Operating Procedure for Primary and Secondary Packaging of Capsules Department Capsule Packaging SOP No. SOP/CP/206/2025 Supersedes SOP/CP/206/2022 Page No. Page 1 of 7 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP provides the procedure for the primary…

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Capsules V 2.0

BA-BE Studies: SOP for Maintaining Investigator Site File (ISF) – V 2.0

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BA-BE Studies: SOP for Maintaining Investigator Site File (ISF) – V 2.0 Standard Operating Procedure for Maintaining Investigator Site File (ISF) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/026/2025 Supersedes SOP/BA-BE/026/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the standard procedure for…

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BA-BE Studies V 2.0

Aerosol: SOP for Long-Term Stability Studies of Aerosol Dosage Forms – V 2.0

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Aerosol: SOP for Long-Term Stability Studies of Aerosol Dosage Forms – V 2.0 SOP for Long-Term Stability Studies of Aerosol Dosage Forms Department Aerosol SOP No. SOP/Aerosol/102/2025 Supersedes SOP/Aerosol/102/2022 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…

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Aerosols V 2.0

Capsule: SOP for Packaging of Capsules with Desiccants – V 2.0

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Capsule: SOP for Packaging of Capsules with Desiccants – V 2.0 Standard Operating Procedure for Packaging of Capsules with Desiccants Department Capsule Packaging SOP No. SOP/CP/205/2025 Supersedes SOP/CP/205/2022 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 describe the procedure…

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Capsules V 2.0

Tablets: SOP for Approval of Packaging Material Specifications – V 2.0

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Tablets: SOP for Approval of Packaging Material Specifications – V 2.0 Standard Operating Procedure for Approval of Packaging Material Specifications Department Tablet SOP No. SOP/TAB/213/2025 Supersedes SOP/TAB/213/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose This SOP outlines the procedure for the approval of packaging material…

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Tablet Manufacturing V2.0