What you'll learn:
- Understand and define main principles of Process Validation by integrating Good Manufacturing Practices (GMP)
- Define general scope of quality management in pharmaceutical industry by understanding key definitions of Quality
- Understand and define main principles of Qualification, Calibration and Validation
- Evaluate important points of Quality Management (QM) in pharmaceutical industry
- Discuss similarities and differencies of FDA and EMA guideline about Process Validation
- Prepare Process Validation Protocol by understanding validation requirements
- Understand sampling plan requirements by using risk assesment, and CMA, CPP, CQA approaches
- Understand risk assesment, process capability and process stability approaches
- Prepare Process Validation Report by evaluating data and process capability
- Evaluate important points of Quality Systems (QS) in pharmaceutical industry
- Understand and define main principles of Process Validation by integrating Good Manufacturing Practices (GMP)
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 CONTENT
1 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
