Tag: stability testing SOP gel

Gel Manufacturing: SOP for Investigating Gel Batch Failures – V 2.0

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Gel Manufacturing: SOP for Investigating Gel Batch Failures – V 2.0 Standard Operating Procedure for Investigation of Gel Batch Failures in Manufacturing Department Gel Manufacturing SOP No. SOP/GM/088/2025 Supersedes SOP/GM/088/2022 Page No. Page 1 of 14 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose To define a systematic procedure for investigating failures…

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Gel Manufacturing: SOP for Validating Cleaning Procedures for Gel Equipment – V 2.0

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Gel Manufacturing: SOP for Validating Cleaning Procedures for Gel Equipment – V 2.0 Standard Operating Procedure for Validation of Cleaning Procedures for Equipment in Gel Manufacturing Department Gel Manufacturing SOP No. SOP/GM/087/2025 Supersedes SOP/GM/087/2022 Page No. Page 1 of 12 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose To define the procedure…

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Gel Manufacturing: SOP for Change Control in Gel Manufacturing Processes – V 2.0

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Gel Manufacturing: SOP for Change Control in Gel Manufacturing Processes – V 2.0 Standard Operating Procedure for Change Control in Gel Manufacturing Processes Department Gel Manufacturing SOP No. SOP/GM/086/2025 Supersedes SOP/GM/086/2022 Page No. Page 1 of 12 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose To define a systematic approach for initiating,…

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Gel Manufacturing: SOP for Conducting Supplier Audits for Raw Materials – V 2.0

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Gel Manufacturing: SOP for Conducting Supplier Audits for Raw Materials – V 2.0 Standard Operating Procedure for Conducting Supplier Audits for Raw Materials in Gel Manufacturing Department Gel Manufacturing SOP No. SOP/GM/085/2025 Supersedes SOP/GM/085/2022 Page No. Page 1 of 11 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose To provide a standardized…

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Gel Manufacturing: SOP for Qualification of Gel Manufacturing Equipment – V 2.0

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Gel Manufacturing: SOP for Qualification of Gel Manufacturing Equipment – V 2.0 Standard Operating Procedure for Qualification of Equipment Used in Gel Manufacturing Department Gel Manufacturing SOP No. SOP/GM/084/2025 Supersedes SOP/GM/084/2022 Page No. Page 1 of 12 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose To define the systematic approach for qualification…

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Gel Manufacturing: SOP for Conducting Internal Audits of Gel Production – V 2.0

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Gel Manufacturing: SOP for Conducting Internal Audits of Gel Production – V 2.0 Standard Operating Procedure for Internal Audits in Gel Manufacturing Operations Department Gel Manufacturing SOP No. SOP/GM/083/2025 Supersedes SOP/GM/083/2022 Page No. Page 1 of 11 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose This SOP defines the systematic approach to…

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Gel Manufacturing: SOP for Handling Deviations During Gel Manufacturing – V 2.0

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Gel Manufacturing: SOP for Handling Deviations During Gel Manufacturing – V 2.0 Standard Operating Procedure for Managing Deviations in Gel Manufacturing Department Gel Manufacturing SOP No. SOP/GM/082/2025 Supersedes SOP/GM/082/2022 Page No. Page 1 of 11 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose This SOP defines the procedure for identifying, documenting, investigating,…

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Gel Manufacturing: SOP for Batch Record Review for Gels – V 2.0

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Gel Manufacturing: SOP for Batch Record Review for Gels – V 2.0 Standard Operating Procedure for Reviewing Batch Records in Gel Manufacturing Department Gel Manufacturing SOP No. SOP/GM/081/2025 Supersedes SOP/GM/081/2022 Page No. Page 1 of 11 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose To establish a standard procedure for reviewing batch…

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Gel Manufacturing: SOP for Recording and Reporting In-Process Control Data – V 2.0

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Gel Manufacturing: SOP for Recording and Reporting In-Process Control Data – V 2.0 Standard Operating Procedure for Recording and Reporting In-Process Control Data in Gel Manufacturing Department Gel Manufacturing SOP No. SOP/GM/080/2025 Supersedes SOP/GM/080/2022 Page No. Page 1 of 12 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose To define a standardized…

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Gel Manufacturing: SOP for Immediate Corrective Actions in Case of Deviations – V 2.0

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Gel Manufacturing: SOP for Immediate Corrective Actions in Case of Deviations – V 2.0 Standard Operating Procedure for Handling Immediate Corrective Actions During Deviations in Gel Manufacturing Department Gel Manufacturing SOP No. SOP/GM/079/2025 Supersedes SOP/GM/079/2022 Page No. Page 1 of 11 Issue Date 02/06/2025 Effective Date 04/06/2025 Review Date 02/06/2026 1. Purpose This Standard Operating…

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