Tag: SOP for autoclave sterilization

Quality Assurance: SOP for Documentation of Change Control Processes – V 2.0 Standard Operating Procedure for Documentation of Change Control Processes Department Quality Assurance SOP No. SOP/QA/190/2025 Supersedes SOP/QA/190/2022 Page No. Page 1 of 12 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define a systematic approach for initiating, reviewing, implementing,…

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Quality Assurance: SOP for Establishing Critical Quality Attributes for Sterile Products – V 2.0 Standard Operating Procedure for Establishing Critical Quality Attributes (CQAs) for Sterile Products Department Quality Assurance SOP No. SOP/QA/189/2025 Supersedes SOP/QA/189/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define the procedure…

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Quality Assurance: SOP for Approving New Packaging Materials for Injectable Products – V 2.0 Standard Operating Procedure for Approving New Packaging Materials for Injectable Products Department Quality Assurance SOP No. SOP/QA/188/2025 Supersedes SOP/QA/188/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To establish a standardized procedure…

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Quality Assurance: SOP for Supplier Qualification Audits – V 2.0 Standard Operating Procedure for Supplier Qualification Audits in Quality Assurance Department Quality Assurance SOP No. SOP/QA/187/2025 Supersedes SOP/QA/187/2022 Page No. Page 1 of 12 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the methodology and procedural requirements for conducting…

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Quality Assurance: SOP for Root Cause Analysis in QA Investigations – V 2.0 Standard Operating Procedure for Root Cause Analysis in Quality Assurance Investigations Department Quality Assurance SOP No. SOP/QA/186/2025 Supersedes SOP/QA/186/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define a systematic and standardized…

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Quality Assurance: SOP for Risk Mitigation Strategies in QA Activities – V 2.0 Standard Operating Procedure for Risk Mitigation Strategies in Quality Assurance Activities Department Quality Assurance SOP No. SOP/QA/185/2025 Supersedes SOP/QA/185/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To establish a comprehensive and proactive…

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Quality Assurance: SOP for Managing Deviations in Quality Assurance Processes – V 2.0 Standard Operating Procedure for Managing Deviations in Quality Assurance Processes Department Quality Assurance SOP No. SOP/QA/184/2025 Supersedes SOP/QA/184/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define a systematic approach for identifying,…

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Quality Control: SOP for Reviewing QC Test Results before Product Release – V 2.0 Standard Operating Procedure for Reviewing QC Test Results before Product Release in Injectable Manufacturing Department Quality Control SOP No. SOP/QC/183/2025 Supersedes SOP/QC/183/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To establish…

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Quality Assurance: SOP for Preparing Annual Product Quality Review (APQR) Reports – V 2.0 Standard Operating Procedure for Preparing Annual Product Quality Review (APQR) Reports in Injectable Manufacturing Department Quality Assurance SOP No. SOP/QA/182/2025 Supersedes SOP/QA/182/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define…

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Quality Assurance: SOP for Internal Quality Audits in Injectable Manufacturing – V 2.0 Standard Operating Procedure for Internal Quality Audits in Injectable Manufacturing Department Quality Assurance SOP No. SOP/QA/181/2025 Supersedes SOP/QA/181/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define the standard procedure for planning,…

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