Tag: GMP tablet manufacturing SOP

Tablets: SOP for Out-of-Specification (OOS) Results Investigation – V 2.0 Standard Operating Procedure for Out-of-Specification (OOS) Results Investigation Department Tablet SOP No. SOP/TAB/181/2025 Supersedes SOP/TAB/181/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To establish procedures for the investigation of Out-of-Specification (OOS) results in tablet production,…

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Tablets: SOP for Internal Audits of Tablet Manufacturing Facilities – V 2.0 Standard Operating Procedure for Internal Audits of Tablet Manufacturing Facilities Department Tablet SOP No. SOP/TAB/180/2025 Supersedes SOP/TAB/180/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To outline the procedures for conducting internal audits in…

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Tablets: SOP for Compliance with cGMP Guidelines in Tablet Production – V 2.0 Standard Operating Procedure for Compliance with cGMP Guidelines in Tablet Production Department Tablet SOP No. SOP/TAB/179/2025 Supersedes SOP/TAB/179/2022 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 procedures for ensuring compliance…

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Tablets: SOP for Calibration of Critical Equipment in Tablet Manufacturing – V 2.0 Standard Operating Procedure for Calibration of Critical Equipment in Tablet Manufacturing Department Tablet SOP No. SOP/TAB/178/2025 Supersedes SOP/TAB/178/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To establish procedures for the calibration of…

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Tablets: SOP for Vendor Qualification for Raw Materials Used in Tablets – V 2.0 Standard Operating Procedure for Vendor Qualification for Raw Materials Used in Tablets Department Tablet SOP No. SOP/TAB/177/2025 Supersedes SOP/TAB/177/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To establish the procedures for…

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Annexure-5: Cleaning Log Cleaning Date Area Cleaned Cleaning Personnel Cleaning Agent Used Remarks 01/01/2026 Production Area 1 John Doe Disinfectant X Cleaned according to SOP 02/01/2026 Packaging Area Jane Smith Disinfectant Y Minor debris removed Annexure-6: Cleanroom Record Retention Log Document Type Retention Period Storage Location Record Retention End Date Responsible Person Cleanroom Classification Record…

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Tablets: SOP for Monitoring and Maintaining Cleanroom Classifications – V 2.0 Standard Operating Procedure for Monitoring and Maintaining Cleanroom Classifications Department Tablet SOP No. SOP/TAB/176/2025 Supersedes SOP/TAB/176/2022 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 procedures for monitoring and maintaining the cleanliness and…

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Tablets: SOP for Documentation Control in Tablet Manufacturing Units – V 2.0 Standard Operating Procedure for Documentation Control in Tablet Manufacturing Units Department Tablet SOP No. SOP/TAB/175/2025 Supersedes SOP/TAB/175/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To establish procedures for the control and management of…

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Tablets: SOP for Training of Personnel in Tablet Manufacturing Areas – V 2.0 Standard Operating Procedure for Training of Personnel in Tablet Manufacturing Areas Department Tablet SOP No. SOP/TAB/174/2025 Supersedes SOP/TAB/174/2022 Page No. Page 1 of 6 Issue Date 01/03/2026 Effective Date 06/03/2026 Review Date 01/03/2027 1. Purpose To establish a procedure for the training…

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Tablets: SOP for Change Control in Tablet Manufacturing Processes – V 2.0 Standard Operating Procedure for Change Control in Tablet Manufacturing Processes Department Tablet SOP No. SOP/TAB/173/2025 Supersedes SOP/TAB/173/2022 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 managing changes to tablet…

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