Three Principles of GMP

Drugs associate closely with human lives. Therefore, the drug after production must achieve uniformity and achieve high quality. To ensure that, the drug manufacturing process needs to comply with the following requirements. 1) minimizing human errors, 2) preventing contamination and quality deterioration, and 3) designing a system for high quality assurance. And those are called the three core principles of GMP.

1.      Minimizing human errors during manufacture.

Personnel involved in pharmaceutical manufacture should receive educational training corresponding to the operations they are responsible for, and the record of training should be kept.

In addition, ‘labeling’ is effective to prevent mistakes. The present situation of material, component, packing material and product, even the equipment and process area should be labeled to prevent mistake.

Furthermore, double-check system is required for the check of important operations, such as weighing, etc. to be performed by two people. It is effective to make efforts to introduce the computerized automation system so that the human error can be prevented by reducing the part that relies on personnel.

2.      Preventing contamination and quality deterioration of pharmaceutical products.

In order to prevent the foreign matters (dusts or hair, etc.) from entering into pharmaceutical products, the manufacture should be carried in clean rooms controlled at a certain cleanliness class based on the manufacturing process, and operators should gown properly and wash hands before beginning operation. If multi-productions are operated on a single machine, there will be a potential of cross contamination due to the mix-up with other materials or components. It is also important to maintain correct air flow patterns in the room and keep the equipment clean to prevent the cross contamination induced by foreign matters.

3.      Designing a high-quality assurance system.

Now that the characteristics of pharmaceuticals products are; (a) the quality can’t be judged by its appearance, (b) normally, sampling examination is carried out (It is impossible to test all products), (c) it straight connects to human lives, not only the proper procedures or systems for manufacturing should be prepared, but it should be ensured that all those procedures or systems are exactly performed also.   This high-quality assurance only can be achieved when it is “documented”.

In fact, it is not an exaggeration to say that events relating to the quality ofthe products should be all recorded and documented. As well as the record of training we described above, for instance, prior to starting production, the documented manufacturing order specifying recipe and critical parameters would be issued, so the result of the production according to the manufacturing order and the successful quality test result should be recorded as the basis of release judgment.

It should be documented that cleaning and washing have been done according to determined procedure and frequency. All the receiving tests and storage conditions should be documented. Absolutely, all the manufacturing procedures should be summarized as SOP (Standard Operating Procedures) and controlled after approved by the responsible person. Documented records verify that all planned activities for protecting quality have been exactly implemented. With those documented as evidence, it can be assured that products with high quality have been manufactured.