Quality in Pharmaceutical Industry: GMP & Process Validation

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