{ENGLISH} CHAPTER 4 VALIDATION AND QUALIFICATION – PART 2

CHAPTER 4 VALIDATION AND QUALIFICATION – PART 2

5. Structure of Process Validation

The purpose of process validation is to “scientifically verify that a drug product of stable quality can be reproducibly produced.

The new FDA definition (see Figure 1. Definition of Validation) presented as a means to achieve this can be interpreted as dividing the life cycle of a drug product into three stages, and at each stage, collecting and evaluating data to demonstrate the qualification of the four components of the manufacturing process. The stages explanation already described at Process validation throughout the life cycle, chapter 2.

Pre-condition must be concerned for Stage 1,

– Based on the manufacturing method, equipment to be used and manufacturing standard/ SOP (draft) must be prepared.

– Personnel in charge (PIC) of manufacturing operator and testing personnel are trained based on manufacturing standard.

Looking at stages 1~3 from a different angle, the structure of process validation can be clearly understood. The culmination of process validation is the Production Master Formula, which is located at the top of the process validation pyramid. The scientific basis supporting the Production Master Formula is supported by the vast amount of experimental data at the base of the pyramid

Of all the components of a manufacturing process, the most time-consuming and costly to qualify and the most difficult to handle by the process development department alone is the facility equipment, it is necessary to enlist the help of the engineering department and involve outside facility and equipment vendors.

Some parameters can only be set once the process is actually in operation. In addition, equipment is characterized by the fact that it…