Tag: API hold time

API Manufacturing: SOP for QA Review of Environmental Monitoring Results – V 2.0 Standard Operating Procedure for QA Review of Environmental Monitoring Results in API Manufacturing Department API Manufacturing SOP No. SOP/API/188/2025 Supersedes SOP/API/188/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a procedure…

Read More “API Manufacturing: SOP for QA Review of Environmental Monitoring Results – V 2.0” »

API Manufacturing: SOP for Raw Data Review and Cross-Verification – V 2.0 Standard Operating Procedure for Raw Data Review and Cross-Verification in API Manufacturing Department API Manufacturing SOP No. SOP/API/187/2025 Supersedes SOP/API/187/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for thorough…

Read More “API Manufacturing: SOP for Raw Data Review and Cross-Verification – V 2.0” »

API Manufacturing: SOP for Equipment Qualification Protocol Review – V 2.0 Standard Operating Procedure for Equipment Qualification Protocol Review in API Manufacturing Department API Manufacturing SOP No. SOP/API/186/2025 Supersedes SOP/API/186/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for Quality Assurance (QA)…

Read More “API Manufacturing: SOP for Equipment Qualification Protocol Review – V 2.0” »

API Manufacturing: SOP for Batch Release Authorization by QA – V 2.0 Standard Operating Procedure for Batch Release Authorization by QA in API Manufacturing Department API Manufacturing SOP No. SOP/API/185/2025 Supersedes SOP/API/185/2022 Page No. Page 1 of 16 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for the…

Read More “API Manufacturing: SOP for Batch Release Authorization by QA – V 2.0” »

API Manufacturing: SOP for Batch Number Generation and Control – V 2.0 Standard Operating Procedure for Batch Number Generation and Control in API Manufacturing Department API Manufacturing SOP No. SOP/API/184/2025 Supersedes SOP/API/184/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for the…

Read More “API Manufacturing: SOP for Batch Number Generation and Control – V 2.0” »

API Manufacturing: SOP for Issuance and Control of Logbooks – V 2.0 Standard Operating Procedure for Issuance and Control of Logbooks in API Manufacturing Department API Manufacturing SOP No. SOP/API/183/2025 Supersedes SOP/API/183/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for issuance,…

Read More “API Manufacturing: SOP for Issuance and Control of Logbooks – V 2.0” »

API Manufacturing: SOP for QA Oversight During Manufacturing and Packaging – V 2.0 Standard Operating Procedure for QA Oversight During Manufacturing and Packaging in API Manufacturing Department API Manufacturing SOP No. SOP/API/182/2025 Supersedes SOP/API/182/2022 Page No. Page 1 of 16 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a standard…

Read More “API Manufacturing: SOP for QA Oversight During Manufacturing and Packaging – V 2.0” »

API Manufacturing: SOP for Mock Recall Procedure and Execution – V 2.0 Standard Operating Procedure for Mock Recall Procedure and Execution in API Manufacturing Department API Manufacturing SOP No. SOP/API/181/2025 Supersedes SOP/API/181/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To outline the procedure for planning,…

Read More “API Manufacturing: SOP for Mock Recall Procedure and Execution – V 2.0” »

API Manufacturing: SOP for Vendor Qualification and Re-Evaluation – V 2.0 Standard Operating Procedure for Vendor Qualification and Re-Evaluation in API Manufacturing Department API Manufacturing SOP No. SOP/API/180/2025 Supersedes SOP/API/180/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a standard procedure for the qualification…

Read More “API Manufacturing: SOP for Vendor Qualification and Re-Evaluation – V 2.0” »

API Manufacturing: SOP for APQR Compilation for Regulatory Use – V 2.0 Standard Operating Procedure for APQR Compilation for Regulatory Use in API Manufacturing Department API Manufacturing SOP No. SOP/API/179/2025 Supersedes SOP/API/179/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for the…

Read More “API Manufacturing: SOP for APQR Compilation for Regulatory Use – V 2.0” »