{ENGLISH} CHAPTER 4 VALIDATION AND QUALIFICATION – PART 1

CHAPTER 4 VALIDATION AND QUALIFICATION – PART 1

1. Introduction

Thorough quality control is required in the manufacture of pharmaceuticals, which can affect human lives. Quality control is important but not only that, therefore it is necessary to prove through scientific methods that products of the target quality can be produced stably, without relying only on product testing. This activity is a process validation.

To ensure that quality is maintained, the following questions must be answered:

1) What conditions should the product be manufactured? What should be monitored? How to monitor? What is the acceptable range of the monitored values?

(2) Confirm that the manufacturing process is operating as planned using actual production facilities and that products of the target quality are produced, and

(3) Confirm that pharmaceutical products of the target quality are being produced even after the transition to commercial production and evaluate the data to see if there is any room for improvement.

The series of activities described in (1), (2), and (3) above, where data are evaluated, is called process validation.

2. Definition of Process Validation

The concept of process validation was introduced by the FDA in 1987 as a means of embodying the idea of “incorporating quality into the process,” based on the recognition that the quality of a drug product cannot be completely guaranteed simply by testing and inspecting the final product. It is said, “to establish evidence that a drug product of the intended quality can be manufactured”.

The introduction of process validation has undoubtedly had a significant impact on the pharmaceutical industry and contributed to the improvement of GMP levels, but on…