The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Creams: SOP for Color Consistency Testing in Creams – V 2.0 Standard Operating Procedure for Color Consistency Testing in Creams Department Creams SOP No. SOP/CRM/138/2025 Supersedes SOP/CRM/138/2022 Page No. Page 1 of 5 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose The purpose of this SOP is to define the procedure for…
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Elixir Department: SOP for Label Generation and Application in Dispensing – V 2.0 Standard Operating Procedure for Label Generation and Application During Material Dispensing Department Elixir Department SOP No. SOP/ELX/041/2025 Supersedes SOP/ELX/041/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose This SOP outlines the procedure for…
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API Manufacturing: SOP for Visual Inspection of Semi-Solid Intermediates – V 2.0 Standard Operating Procedure for Visual Inspection of Semi-Solid Intermediates in API Manufacturing Department API Manufacturing SOP No. SOP/API/096/2025 Supersedes SOP/API/096/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define the standard procedure for…
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BA-BE Studies: SOP for Documenting Protocol Violations and CAPA – V 2.0 Standard Operating Procedure for Documenting Protocol Violations and CAPA in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/115/2025 Supersedes SOP/BA-BE/115/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a uniform process for…
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Biosimilars: SOP for Documentation of Clone Selection and Results – V 2.0 Standard Operating Procedure for Documentation of Clone Selection and Results in Biosimilar Development Department Biosimilars SOP No. SOP/BS/049/2025 Supersedes SOP/BS/049/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized system for…
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Analytical Method Development: pH Method Development for API – V 2.0 SOP for pH Method Development of Active Pharmaceutical Ingredients in AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/042/2025 Supersedes SOP/AMD/042/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP defines the procedure for…
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API Manufacturing: SOP for Intermediate Moisture Check using IR Balance – V 2.0 Standard Operating Procedure for Intermediate Moisture Check using IR Balance in API Manufacturing Department API Manufacturing SOP No. SOP/API/095/2025 Supersedes SOP/API/095/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define a standardized…
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BA-BE Studies: SOP for Preventing Cross-Contamination of Samples – V 2.0 Standard Operating Procedure for Preventing Cross-Contamination of Samples in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/114/2025 Supersedes SOP/BA-BE/114/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a robust and standardized procedure for…
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Aerosol: SOP for Documenting Equipment Qualification Reports – V 2.0 SOP for Documenting Equipment Qualification Reports Department Aerosol SOP No. SOP/Aerosol/138/2025 Supersedes SOP/Aerosol/138/2022 Page No. Page 1 of Y Issue Date 06/02/2025 Effective Date 16/02/2025 Review Date 06/02/2028 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for documenting equipment…
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Elixir Department: SOP for Dispensing Light Sensitive Materials – V 2.0 Standard Operating Procedure for Dispensing Light Sensitive Materials in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/040/2025 Supersedes SOP/ELX/040/2022 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 accurate…
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