The more the better, for all kinds of comparisons between the old and new GMPs.

The characteristics of the new version of GMP are different from the old version of GMP, which are mainly reflected in the following aspects:

First, the management requirements have been strengthened.

First, the requirements for personnel have been raised.

Second, it is clear that enterprises are required to establish a drug quality management system.

The third is to refine the requirements for the management of operating procedures, production records and other documents.

Second, some hardware requirements have been raised.

First, the cleanliness requirements of the production environment of sterile preparations have been adjusted.

Second, the requirements for equipment and facilities have been increased.

Third, a series of new systems have been added around quality risk management.

The new version of GMP introduces the concept of quality risk management and adds a series of new systems, such as: audit and approval of suppliers, change control, deviation management, investigation of exceeding standards, corrective and preventive measures, continuous stability inspection plan, product quality review and analysis, etc.

Fourth, it emphasizes the effective connection with other regulatory links such as drug registration and drug recall.

The new version of the GMP emphasizes the consistency of production requirements and registration approval requirements in several chapters. The new version of the drug GMP also focuses on the connection with the "Drug Recall Management Measures".

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There is a certain correlation between the new version of GMP and the old version of GMP, but it cannot be accurately corresponded, and can only be roughly replaced: A-level area represents 100-level clean area, B-level area represents 10,000-level clean area, C-level area represents 100,000-level clean area, D-level area represents 300,000-level clean area, and national standards and ISO standards cannot accurately correspond due to different calculation methods and requirements.

Differences between the new GMP and the old GMP:

1. The reference standards are different.

The new version of GMP is based on the EU GMP, with reference to the GMP of the WHO, the United States and Japan, and is formulated according to the actual situation of China's pharmaceutical manufacturers.

The old GMP classification is based on the American cleanroom classification.

2. There are changes in dynamic and static monitoring requirements.

The new version of GMP requires both dynamic and static monitoring;

The old version of GMP only had static regulations, and there were no dynamic requirements.

3. There are changes in the description of the corresponding background for different levels.

Class A static and dynamic are equivalent to level, Class B static is ISO5, dynamic ISO7, Class C static ISO7, dynamic ISO8, to D level, the level is already relatively low, so there is no dynamic requirement, only static requirement is ISO8.

The old version of GMP only required static monitoring.

4. The monitoring requirements of sedimentation bacteria and plankton bacteria have changed.

The new version of GMP has requirements for the monitoring of sedimentation bacteria and planktonic bacteria; The old version of GMP does not require the monitoring of sedimentation bacteria and planktonic bacteria.

The difference between the old and new versions of GMP is like a bird's eye

1. The reference to the standard is different. Cherry blossom row.

2. The monitoring time of sedimentation bacteria is different.

Question 1: There are differences between A, B, C, and D levels (hereinafter collectively referred to as the "new GMP") and 100-level areas, 10,000-level areas, and 100,000-level areas (hereinafter collectively referred to as the "old GMP"), and the main differences are as follows:

1. The criteria for dividing the reference are different.

The division of the new version of GMP is based on the EU ISO standard;

The old GMP classification is based on the American cleanroom classification.

2. There are changes in dynamic and static monitoring requirements.

The new version of GMP requires both dynamic and static monitoring;

The old version of GMP only required static monitoring.

3. The monitoring requirements of sedimentation bacteria and plankton bacteria have changed.

The new version of GMP has requirements for the monitoring of sedimentation bacteria and planktonic bacteria;

The old version of GMP does not require the monitoring of sedimentation bacteria and planktonic bacteria.

4. The standard of dust particles has changed.

The new version of GMP has strict standards for dust particles;

The old version of GMP had a low standard for dust particles.

5. There is a change in the monitoring time of sedimentation bacteria.

The new version of GMP has a long monitoring time for sedimentation bacteria;

The old version of GMP had a shorter monitoring time for sedimentation bacteria.

6. The illumination requirements have changed.

The new version of GMP has low requirements for comparability;

The old version of GMP has high requirements for comparison.

Problem 2: There is a certain correlation between the new version of GMP and the old version of GMP, but it cannot be accurately corresponded, and some rough conversions can be performed.

In the new version of GMP, A-level dynamic is equivalent to level; Class B static equivalent to ISO5, dynamic equivalent to ISO7; Class C static equivalent to ISO7, dynamic equivalent to ISO8; Class D static requirements are ISO8.

In the old GMP system, 100 is roughly equivalent to ISO5, 100,000 is roughly equivalent to ISO7, and 100,000 is roughly equivalent to ISO8.

That is, B-level static is about equivalent to 100-level, B-level is about equivalent to 10,000-level, C-level dynamic and D-level static are about equivalent to 100,000 level.

The cleanroom concept of the old version of GMP cannot be equated with the new version, as mentioned above, ABCD contains dynamic requirements and cannot be simply converted. The old version of the requirements was static, so the management requirements were much worse. It is recommended to use ISO to convert, which is more scientific and objective.