Tag: Capsule deviation management

Capsule: SOP for Heavy Metal Testing of Capsule Materials – V 2.0

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Capsule: SOP for Heavy Metal Testing of Capsule Materials – V 2.0 Standard Operating Procedure for Heavy Metal Testing of Capsule Materials Department Capsule Manufacturing SOP No. SOP/CM/186/2025 Supersedes SOP/CM/186/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP defines the procedure for performing heavy…

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Capsules V 2.0

Capsule: SOP for Microbial Limit Testing for Capsules – V 2.0

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Capsule: SOP for Microbial Limit Testing for Capsules – V 2.0 Standard Operating Procedure for Microbial Limit Testing for Capsules Department Capsule Manufacturing SOP No. SOP/CM/185/2025 Supersedes SOP/CM/185/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose This SOP defines the procedure for conducting microbial limit testing…

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Capsules V 2.0

Capsule: SOP for Assay Testing of Capsule Fill Materials – V 2.0

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Capsule: SOP for Assay Testing of Capsule Fill Materials – V 2.0 Standard Operating Procedure for Assay Testing of Capsule Fill Materials Department Capsule Manufacturing SOP No. SOP/CM/184/2025 Supersedes SOP/CM/184/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose To outline the procedure for performing assay testing…

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Capsules V 2.0

Capsule: SOP for Uniformity of Content Testing for Capsules – V 2.0

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Capsule: SOP for Uniformity of Content Testing for Capsules – V 2.0 Standard Operating Procedure for Uniformity of Content Testing for Capsules Department Capsule Manufacturing SOP No. SOP/CM/183/2025 Supersedes SOP/CM/183/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to define…

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Capsules V 2.0

Capsule: SOP for Capsule Weight Variation Testing – V 2.0

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Capsule: SOP for Capsule Weight Variation Testing – V 2.0 Standard Operating Procedure for Capsule Weight Variation Testing Department Capsule Manufacturing SOP No. SOP/CM/182/2025 Supersedes SOP/CM/182/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to define the procedure for performing…

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Capsules V 2.0

Capsule: SOP for Visual Inspection of Capsule Shells – V 2.0

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Capsule: SOP for Visual Inspection of Capsule Shells – V 2.0 Standard Operating Procedure for Visual Inspection of Capsule Shells Department Capsule Manufacturing SOP No. SOP/CM/181/2025 Supersedes SOP/CM/181/2022 Page No. Page 1 of 8 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to define the procedure…

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Capsules V 2.0

Capsule: SOP for Validation of In-Process Testing for Capsules – V 2.0

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Capsule: SOP for Validation of In-Process Testing for Capsules – V 2.0 Standard Operating Procedure for Validation of In-Process Testing for Capsules Department Capsule Manufacturing SOP No. SOP/CM/180/2025 Supersedes SOP/CM/180/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to establish…

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Capsules V 2.0

Capsule: SOP for Validation of Capsule Packing Processes – V 2.0

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Capsule: SOP for Validation of Capsule Packing Processes – V 2.0 Standard Operating Procedure for Validation of Capsule Packing Processes Department Capsule Manufacturing SOP No. SOP/CM/179/2025 Supersedes SOP/CM/179/2022 Page No. Page 1 of 10 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to define the process…

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Capsules V 2.0

Capsule: SOP for Validation of Granulation Processes for Capsules – V 2.0

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Capsule: SOP for Validation of Granulation Processes for Capsules – V 2.0 Standard Operating Procedure for Validation of Granulation Processes for Capsules Department Capsule Manufacturing SOP No. SOP/CM/178/2025 Supersedes SOP/CM/178/2022 Page No. Page 1 of 10 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to establish…

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Capsules V 2.0

Capsule: SOP for Validation of Stability Studies for Capsules – V 2.0

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Capsule: SOP for Validation of Stability Studies for Capsules – V 2.0 Standard Operating Procedure for Validation of Stability Studies for Capsules Department Capsule Manufacturing SOP No. SOP/CM/177/2025 Supersedes SOP/CM/177/2022 Page No. Page 1 of 9 Issue Date 01/02/2025 Effective Date 05/02/2025 Review Date 01/02/2026 1. Purpose The purpose of this SOP is to establish…

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Capsules V 2.0