Tag: Elixir manufacturing process

Elixir Department: SOP for Notification Protocol for IPC Failures – V 2.0

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Elixir Department: SOP for Notification Protocol for IPC Failures – V 2.0 Standard Operating Procedure for Notification Protocol for IPC Failures in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/209/2025 Supersedes SOP/ELX/209/2022 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 immediate…

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Elixir Department: SOP for Use of Mobile IPC Labs – V 2.0

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Elixir Department: SOP for Use of Mobile IPC Labs – V 2.0 Standard Operating Procedure for Use of Mobile IPC Labs in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/208/2025 Supersedes SOP/ELX/208/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for operation,…

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Elixir Department: SOP for Record Maintenance of IPC Results – V 2.0

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Elixir Department: SOP for Record Maintenance of IPC Results – V 2.0 Standard Operating Procedure for Record Maintenance of In-Process Control (IPC) Results Department Elixir Department SOP No. SOP/ELX/207/2025 Supersedes SOP/ELX/207/2022 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 accurate,…

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Elixir Department: SOP for Titration of pH Buffers – V 2.0

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Elixir Department: SOP for Titration of pH Buffers – V 2.0 Standard Operating Procedure for Titration of pH Buffers Used in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/206/2025 Supersedes SOP/ELX/206/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for preparation, titration,…

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Elixir Department: SOP for Weight per mL Testing – V 2.0

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Elixir Department: SOP for Weight per mL Testing – V 2.0 Standard Operating Procedure for Weight per mL Testing During Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/205/2025 Supersedes SOP/ELX/205/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To lay down the procedure for performing and…

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Elixir Department: SOP for Time-Based Sampling Schedule – V 2.0

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Elixir Department: SOP for Time-Based Sampling Schedule – V 2.0 Standard Operating Procedure for Time-Based Sampling Schedule During Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/204/2025 Supersedes SOP/ELX/204/2022 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 standardized procedure for implementing and documenting a…

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Elixir Department: SOP for Real-Time API Content Verification – V 2.0

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Elixir Department: SOP for Real-Time API Content Verification – V 2.0 Standard Operating Procedure for Real-Time API Content Verification in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/203/2025 Supersedes SOP/ELX/203/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for performing real-time verification…

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Elixir Department: SOP for Conductivity Monitoring – V 2.0

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Elixir Department: SOP for Conductivity Monitoring – V 2.0 Standard Operating Procedure for Conductivity Monitoring in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/202/2025 Supersedes SOP/ELX/202/2022 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 standardized procedure for monitoring conductivity during the elixir manufacturing…

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Elixir Department: SOP for In-Process Filter Integrity Testing – V 2.0

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Elixir Department: SOP for In-Process Filter Integrity Testing – V 2.0 Standard Operating Procedure for In-Process Filter Integrity Testing in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/201/2025 Supersedes SOP/ELX/201/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for performing integrity testing…

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Elixir Department: SOP for Homogeneity Sampling – V 2.0

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Elixir Department: SOP for Homogeneity Sampling – V 2.0 Standard Operating Procedure for Homogeneity Sampling in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/200/2025 Supersedes SOP/ELX/200/2022 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 procedure for conducting homogeneity sampling during elixir manufacturing to…

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