GMP is regularly and dynamically revised, how can the system better match the update speed of GMP?

GMP revision is because the development and conditions of the domestic pharmaceutical industry can not catch up with the world's developed countries in the same industry, which requires us to implement cGMP at the same time to learn other advanced things, such as the scale of process validation, which is now internationally known as the process performance confirmation, and the R & D stage of the validation is called the process design confirmation.

Now that it is easy to download online, we can see the GMP documents of many foreign companies, and we find that the revised GMP has been implemented for them for a long time, so we should always be on par with them. In addition, ICH Q1~Q10 is also something we should learn, and ISPE should also be paid attention to.

The new version of GMP in fact, many concepts in the 2008 certification inspection guide has long been reflected, many concepts in the National Bureau of training and consultation has been put forward, which requires us to pay attention to the timely. Whether it is the new version or the old version of the GMP in fact some aspects of the ISO quality management system and the national television and radio put forward earlier TQM more detailed, then we can only be in the construction of the time on the high not low.

Many related regulations, such as plant building codes, layout specifications, fire prevention and fire code, clean plant design and acceptance specifications, air conditioning and purification system installation and acceptance of norms, measurement and licensing regulations, as well as a variety of national standards, many of which are not the original GMP regulations we did not correctly implement the GMP regulations are now added to the regulations.

In addition, the strangest thing is that other industries are basically standard equipment, there are national standards; pharmaceutical equipment, on the contrary, most of the non-standard, which caused some difficulties in the management. It is necessary to point out that although it is non-standard, but should be managed according to the standard, if you can collect the very early YY type of national standards to guide the present is also meaningful.

There is a new concept of "risk assessment" for GMP is something new, for other industries is not new. Just like the standards we use to guide cleanliness don't come from pharma and hospitals, they come from the electronics industry.

There was the melamine incident in the food hygiene industry, and the tainted capsule incident in the pharmaceutical industry. These are obvious problems that we have deliberately ignored. Looking back, our GMP thoroughly implemented?