The Initial Steps Toward Understanding GMP for Drugs: 1

1. Introduction

Taking this opportunity to write a serial, I would like to provide our readers who are involved in GMP-related tasks from rookies to those who have years of experience  with some introductory reading on Good Manufacturing Practice (GMP).
In general, people see GMP as standard which must be complied with. In my opinion, it is important to see GMP as a system which ensures quality of drugs (a quality system). Therefore, I would like to share what the perspective of quality systems is. I hope you find my serial useful.

2. The Perspective of Quality Systems

What is a quality system which ensures quality of drugs? Let me describe that by using an example of "chair-making".

You would understand instantly if you have any experience in GMP. The procedures shown above is a "quality system". Making a statement saying, "We made a masterpiece!", will never ensure quality. The bottom line of quality assurance is that your product was manufactured in a "quality system". In other words, you can assure quality of your products only when both "quality of the product itself" and "the fact that your quality system works without any problem" work. This is the essence of GMP.

At the manufacturing site, your staff may sometimes come up with an easy way out. For instance, a product passed its release test but its process validation failed due to deviation. Your staff may suggest that the product can be released as the release test shows that the product has no quality issues. This is a wrong idea. You cannot ensure quality when a problem is found in validation, which is one of the critical activities in your quality system, even though the product itself is free from quality issues. Therefore, the only right decision is not to release the product. The basis for this quality assurance approach, which takes into account quality systems, can be found in ISO 9001.