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 GENERAL DEFINITIONS FOR PROCESS VALIDATION-IV 2 4 1 Calibration 2 4 2 Qualification 2 4 3 Types of Qualification 2 4 4 Validation 2 4 5 Types of Validation 2 5 GENERAL DEFINITIONS FOR PROCESS VALIDATION-V 2 5 1 Commercial Manufacturing Process 2 5 2 Process Validation 2 5 3 Process Design 2 5 4 Process Qualification 2 5 5 Continued Process Verification 2 6 GENERAL DEFINITIONS FOR PROCESS VALIDATION-VI 2 6 1 Critical Material Attribute (CMA) 2 6 2 Critical Process Parameter (CPP) 2 6 3 Critical Quality Attribute (CQA) 2 6 4 Quality Target Product Profile (QTPP) 3 PROCESS VALIDATION ACCORDING TO EMA & FDA 4 INTRODUCTION TO PROCESS VALIDATION 4 1 Introduction to Process Validation 4 2 Approach to Process Validation 4 3 Aims of Process Validation 5 GENERAL CONSIDERATION FOR PROCESS VALIDATION 6 PROCESS DESIGN 6 1 Introduction to Process Design 6 2 Building and Capturing Process Knowledge and Understanding 6 3 Establishing a Strategy for Process Control 7 PROCESS QUALIFICATION 7 1 Introduction to Process Qualification 7 2 Design of a Facility and Qualification of Utilities and Equipment 7 3 Process Performance Qualification 7 4 Process Performance Qualification Protocol 7 5 Process Performance Qualification Report 8 CONTINUED PROCESS VERIFICATION 8 1 Continued Process Verification 9 CONCLUSION
