Quality in Pharmaceutical Industry: GMP & Process Validation

Partner: Udemy
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Description: Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics. (FDA Definition)The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. (EMA Definition)In this course, basics of process validation are explained within the all details and requirements. Process validation studies are explained in three major section as process design, process qualification and continued process validation.COURSE CONTENT1 INTRODUCTION 2 GENERAL DEFINITIONS FOR PROCESS VALIDATION 2_1 GENERAL DEFINITIONS FOR PROCESS VALIDATION-I 2_1_1 Drug Product (Pharmaceutical Product) 2_1_2 Active Pharmaceutical Ingredient (API) 2_1_3 Inactive Pharmaceutical Ingredient 2_1_4 Starting Materials 2_1_5 Intermediate Product 2_1_6 Packaging Material 2_1_7 Bulk Product 2_1_8 Finished Pharmaceutical Product (FPP) (Drug Product) (Final Product) 2_1_9 Manufacturing Flow Chart 2_2 GENERAL DEFINITIONS FOR PROCESS VALIDATION-II 2_2_1 Production 2_2_2 Packaging 2_2_3 Manufacture (Mnaufacturing) 2_2_4 Manufacturer 2_2_5 Marketing Authorization (Product Licence) (Registration Certificate) 2_2_6 Quality Assurance 2_2_7 Quality Control 2_2_8 In-Process Control 2_3 GENERAL DEFINITIONS FOR PROCESS VALIDATION-III 2_3_1 Standart Operating Procedure (SOP) 2_3_2 Batch (Lot) 2_3_3 Batch Number (Lot Number) 2_3_4 Batch Record 2_3_5 Master Record 2_3_6 Master Formula 2_3_7 Specification 2_3_8 Authorized Person 2_4 GE
Category: Teaching & Academics > Science > Good Manufacturing Practice (GMP)
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Price: 24.99
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Source: Impact
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