1. Difference:
GMP in the A, B, C, D level of control of dynamic and static points, while the hundred, ten thousand, one hundred thousand is basically no dynamic and static points, there is a clear difference between the two.
The new GMP reference ISO14644 in the specific standards are as follows:?
Cleanliness level suspended particles maximum allowable number / cubic meter static dynamic (3) ≥ 0.5 μm ≥ 5 μm (2) ≥ 0.5 μm ≥ 5 μm;
Class A: 3520[url=12/]20352020?
Class B: 352029352520002900[url=89/]
Class C: 3520002900352000029000?
Class D: 352000029000 is not specified.
2. Contact:
A level corresponds to the dynamic hundred, that is, in dynamic conditions should remain hundred.
Level B corresponds to the static level of 100, that is, in static conditions to meet the level of 100 can be, in dynamic conditions can meet the standards of 10,000, GMP inside the so-called thousands of say.?
Level C corresponds to level 10,000, which meets the standard of level 10,000 under static conditions and level D under dynamic conditions, i.e., level D corresponds to level 10,000 under 100,000 levels.
3. Cannot be converted, because the calculation and requirements are different.
ABCD level is divided by reference to the ISO standard (the way adopted by the European Union), which itself contains static requirements and dynamic requirements.
The old GMP adopted by the U.S. clean room division, the old version of the clean room division only has the concept of static, not dynamic requirements.
In the ABCD system, Class A static and dynamic are equivalent to ISO4.8, that is, Class A is required in accordance with the dynamic.
From level B onwards, there is a difference of one or two levels between static and dynamic.
B level static ISO5, dynamic ISO7, C level static ISo7, dynamic ISO8, to the D level, the level has been relatively low, so there is no dynamic requirements, only static requirements for ISO8.
If you want to convert the hundred level into ISO system, equivalent to ISO5, 10,000 level is equivalent to ISO7, 100,000 level is equivalent to ISO8, 300,000 level in the foreign countries have not adopted. But the concept of clean room between the old version of GMP and the new version can not.
Expanded information:
1. The new version of the GMP clean room (aseptic room, clean room) A,B,C,D corresponding to the level:
Class A is a unidirectional flow, does not take into account the number of times of air change.
Class B has more than 50 air changes.
Grade C is greater than 25 air changes.
Class D air changes are greater than 15.
2. The implementation of the new version of GMP, the enterprise should be how to effectively plan the capital investment in technological transformation?
The newly revised GMP, due to the improvement of the overall standard, the implementation does require enterprises to invest a certain amount of money for technological transformation.
The improvement of GMP software requires corresponding investment; in order to improve the quality of staff, enterprises need to increase the training costs; in order to strengthen the software management, enterprises need to increase the number of management personnel, which will increase the wage bill; the improvement of the GMP hardware for sterile medicines will increase the cost of manufacturing enterprises.
For the issue of investment in technological transformation, due to the different foundations of each enterprise, the production of different varieties, the investment is not the same.
From the various segments, hardware investment is mainly concentrated in sterile drugs, especially lyophilized powdered injections without the final sterilization link, the production process must be improved to ensure the level of sterility. Other products such as oral preparations that do not make aseptic requirements basically do not involve hardware transformation.
Baidu Encyclopedia - GMP