Tag: Elixir pharmacopoeial standards

Elixir Department: SOP for SOP Review and Control – V 2.0

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Elixir Department: SOP for SOP Review and Control – V 2.0 Standard Operating Procedure for SOP Review and Control in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/250/2025 Supersedes SOP/ELX/250/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for the creation, review,…

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Elixir Department: SOP for Vendor Qualification for Raw Materials – V 2.0

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Elixir Department: SOP for Vendor Qualification for Raw Materials – V 2.0 Standard Operating Procedure for Vendor Qualification for Raw Materials in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/249/2025 Supersedes SOP/ELX/249/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a formal procedure for…

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Elixir Department: SOP for Product Release Authorization – V 2.0

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Elixir Department: SOP for Product Release Authorization – V 2.0 Standard Operating Procedure for Product Release Authorization in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/248/2025 Supersedes SOP/ELX/248/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for authorizing the release of finished…

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Elixir Department: SOP for Review of Analytical Data – V 2.0

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Elixir Department: SOP for Review of Analytical Data – V 2.0 Standard Operating Procedure for Review of Analytical Data in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/247/2025 Supersedes SOP/ELX/247/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a standardized procedure for the review…

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Elixir Department: SOP for Documentation Control – V 2.0

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Elixir Department: SOP for Documentation Control – V 2.0 Standard Operating Procedure for Documentation Control in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/246/2025 Supersedes SOP/ELX/246/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a systematic approach for the preparation, approval, issuance, revision, retrieval,…

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Elixir Department: SOP for Risk Assessment During Manufacturing – V 2.0

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Elixir Department: SOP for Risk Assessment During Manufacturing – V 2.0 Standard Operating Procedure for Risk Assessment During Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/245/2025 Supersedes SOP/ELX/245/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for performing structured and systematic risk…

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Elixir Department: SOP for Change Control Procedure – V 2.0

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Elixir Department: SOP for Change Control Procedure – V 2.0 Standard Operating Procedure for Change Control Procedure in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/244/2025 Supersedes SOP/ELX/244/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define a formal system for initiating, evaluating, approving, implementing,…

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Elixir Department: SOP for Deviation Management – V 2.0

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Elixir Department: SOP for Deviation Management – V 2.0 Standard Operating Procedure for Deviation Management in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/243/2025 Supersedes SOP/ELX/243/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the process for identification, documentation, investigation, evaluation, and closure of…

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Elixir Department: SOP for Line Clearance Before and After Manufacturing – V 2.0

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Elixir Department: SOP for Line Clearance Before and After Manufacturing – V 2.0 Standard Operating Procedure for Line Clearance Before and After Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/242/2025 Supersedes SOP/ELX/242/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for conducting…

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Elixir Department: SOP for Destructive vs. Non-Destructive Testing – V 2.0

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Elixir Department: SOP for Destructive vs. Non-Destructive Testing – V 2.0 Standard Operating Procedure for Destructive and Non-Destructive Testing of Elixir Products Department Elixir Department SOP No. SOP/ELX/240/2025 Supersedes SOP/ELX/240/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a standardized procedure for distinguishing and…

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