New GMP certification accelerates industry reshuffle transformation and upgrading

As of the last day of 2013, all or part of the 796 sterile pharmaceutical companies passed the certification, accounting for 60.3% of the nation's sterile pharmaceutical companies. At present, aseptic pharmaceutical companies that have not passed the new version of GMP have successively stopped production and transformation.

It is understood that from this year, non-sterile medicines will also have to meet the new GMP requirements by December 31, 2015. Ma Tao, member of the new GMP drafting expert group and deputy general manager of Wuxi Huarui Company, said: "This action will accelerate the adjustment of China's pharmaceutical industry structure, improve the quality of medicines, increase industry concentration, and some small and medium-sized funds with low capital and technical precipitation. Pharmaceutical companies should be eliminated."

Persisting or Withdrawing After the first gate of the new GMP was dropped, the remaining 523 sterile pharmaceutical companies will all be suspended for production, and non-sterile preparations will be launched one after another. Whether you like it or not, the choice has already been placed in front of the company.

It is understood that, in addition to the high requirements in terms of hardware, the new version of GMP increases the requirements for risk management systems, job training systems, change control, and deviation handling. Different companies have different situations. Is it continuing to apply for certification or to give up?

Most companies think that they can take two paths: either increase investment and actively carry out GMP reform; or transfer approvals and exit some markets. In the case of sterile preparations, for example, enterprises that have not yet passed the certification must choose how the company’s own determination to stay in this market is determined, and whether the company’s equipment and talent team can meet the demand. Judging from the current situation, the overall plausibility of the new version of GMP in terms of technical requirements and inspection criteria has been recognized by the industry.

There are still companies fighting for it. Zhao Guiying, vice president of the China Pharmaceutical Quality Management Association, told reporters that last year their association had done a lot of training on GMP certification, and most companies were very active. “A few companies produced the 2014 output in the previous year. The products continue to be sold, but they continue to apply for certification but have spent more than one year in the buffer period.” She said bluntly, companies that are actually remaking their hopes will be merged.

The key points should be focused on by the end of 2015. All drug companies and all dosage forms throughout the country must pass the new GMP certification, and the next step is to continue. Non-sterile preparations should further improve the quality system, carry out gap analysis in light of their own actual conditions, and clearly define the directions and goals of the transformation. “The assessment and control of risks can only be achieved through in-depth study of product efficacy, production processes, and quality characteristics, based on scientific theories and experimental data. Therefore, the new GMP requirements for quality risk management will greatly enhance the The depth of product characteristics and production process research."

If the company continues to apply, it must be faced with systematic improvement in areas such as clean environment requirements, pressure differentials, air-conditioning purification systems, key equipment and reliability, process validation, production management, and quality management. The challenge.

Some experts also reflected that in the actual certification inspection, the frequency of general defect items in related regulations, job responsibilities, and skills training was high, and some of them even extended to major defects. The main energy of an enterprise should not be placed on the specification itself, but should be placed on the compliance of the above-mentioned links with personnel in key positions that are responsible for the effective operation of the enterprise quality management system.

According to industry insiders, the new version of GMP has effectively promoted the integration of China's pharmaceutical industry with international standards and accelerated the entry of China's pharmaceutical products into the international market. Allowing varieties that have not passed the GMP reform to transfer the approvals to other companies and invigorate production capacity resources. One side is to be in line with international standards and the other side is to phase out production capacity. Whether this will affect supply will still cause speculation and discussion among the industry and the media.

On January 14, the CFDA publicized the first batch of companies meeting the requirements of the new GMP in 2014, 67 companies such as injections of Shandong New Era Pharmaceutical, and penicillin powder injection workshops of Ruiyang Pharmaceutical, etc., in the public list. Experts suggest that companies should develop verification ideas based on their own varieties and process conditions. If there are multiple varieties, the verification of at least three varieties should be completed, and the risk of collinear production must be scientifically and reasonably explained and evaluated.

Many experts bluntly stated that the new version of GMP certification will accelerate the adjustment of the pharmaceutical industry structure, improve the quality of medicines, and increase the degree of industry concentration. Some small drug companies that lack funds and have a lower technological level should be eliminated. Insiders pointed out that enterprises that hopefully will be transformed into hopeless enterprises will certainly be merged. The transformation and upgrading of enterprises should be delayed as early as possible.

This equipment is used in the dangerous and harmful production to replace manual operation. It adopt sucking device, sheet inspector, sensors, PLC, parameter setting and adjusting according to the actural conditions. It imitating human action, grabbing products with fixed procedures, handling item to the set position under setting speed.

With features of precision positioning, stable production quality, working rhythm adjustable, easy maintenance provide the stable running and reliable production quality.

Our high-quality R&D team present you the solution designs including mechanical, software development, circuit, pneumatic, computer system, CAD, 3D design mode and analysis of production conditions.


Stainless Steel Hardware Production line

Mechanical Robot Arm,Automatic Industrial Robot,Metal Press Robot

Shantou Jiesheng Robot Technology Co. Ltd. , http://www.stjsrobot.com

Posted on