What are the changes to the new GMP? What year is the latest GMP?

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Currently, the latest version of GMP is the 10th edition, also known as the "GMP Directive 2023".

This edition was released in 2019 and will officially come into effect in 2023. Compared to previous versions, the 10th edition of the GMP Directive places a greater focus on risk management and technological advancements to ensure the quality and safety of medical products. In addition, the 10th edition introduces a number of new concepts and requirements, such as the design and construction of production sites, verification and validation of production processes, continuous improvement, and risk assessment.

This standard is revised and improved on the basis of the original GMP standard, combined with domestic and foreign drug production practices and regulatory requirements. GMP2010 mainly includes all aspects of drug production, such as drug production facilities, personnel, raw and auxiliary materials, production process, quality control, etc., aiming to ensure that every link of drug production meets the requirements of quality management, so as to ensure the quality and safety of drugs. These requirements will help pharmaceutical companies better manage their production processes, ultimately improving the quality and reliability of their products.

Therefore, pharmaceutical companies need to understand and respond to the requirements of the 10th edition of the GMP Directive in a timely manner to ensure that their products comply with relevant standards and regulations.

It should be noted that the GMP standard is a dynamic standard, and with the continuous development and improvement of drug production technology and management concepts, the standard also needs to be constantly revised and improved. Therefore, in the future, there may be a new version of the GMP standard to adapt to the continuous changes and developments in drug production.

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.

As of August 2021, the latest version of gmp is gmp, which was released in 2019.

GMP stands for "good Manufacturing Practice", which refers to a series of manufacturing and management practices developed to ensure the quality of drugs, food and medical devices. gmp focuses on all aspects of the production phase, including the procurement, production, quality control, storage and distribution of raw materials and finished products. The formulation and implementation of GMP specifications aim to ensure the safety, efficacy and excellent quality of drugs.

GMP specifications are applicable to Jipai pharmaceutical companies around the world, mainly to ensure the smooth progress of global international **. Drug regulatory agencies in various countries approve and supervise the production and distribution of drugs in accordance with their own laws, regulations and GMP requirements to ensure the quality and safety of drugs.

With the continuous updating of technology and the increase of drug varieties, GMP is also constantly improving and updating. The changes in the latest version of GMP are mainly reflected in the following aspects:

1.Risk management requirements have been strengthened. In the process of drug production, it is necessary to assess and manage possible risks to ensure the quality, safety and effectiveness of drugs.

2.Increasing drug quality requirements. The new version of GMP requires stricter control and management of all production links of drugs to ensure that the quality of drugs meets the standard requirements.

3.Emphasis on data integrity and protection. The data in the drug production process must be complete, accurate, authentic and reliable to ensure the quality and safety of the drug.

4.Promote modern technology. The new version of GMP encourages the use of new technologies and equipment to improve the level and efficiency of pharmaceutical production.

In short, GMP norms are constantly updated and upgraded, aiming to continuously improve the quality and safety of medicines and protect public health. Pharmaceutical companies should pay close attention to the updates and changes of GMP norms and actively respond to them.

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.