Can Chinese pharmaceutical manufacturers live up to international GMP requirements?

The Chinese government in the early 2011 announced the final draft of GMP (Good Manufacturing Practice). The pharmaceutical industry is apprehensive whether GMP compliance in China can be successfully implemented. Adopted by many countries, GMP guarantees that pharmaceutical companies of a country would manufacture only unadulterated, effective and quality products. The idea is to ensure availability of safe pharmaceutical products for the end users.

GMP compliance in China is difficult to implement, which is clear from the fact that the draft had to go through five revisions. The results of implementing such regulations during 80\’s and 90\’s were not encouraging. The small to medium-sized Chinese pharmaceutical companies number about 4,000. These companies do not have the financial resources to implement such standards. It is going to result in differences between the set standards and the actual implementation. Because of this, there have been problems in the form of health scares that were related to pharmaceutical products manufactured in China. This type of thing paints the whole Chinese pharmaceutical industry in poor light. The question now being asked is whether these companies are capable of coming out of this negative perception in a globalized environment.

GMP 2010:

In the early 1980s, GMP compliance in China implementation process was restarted. The implementation task was assigned to Medicine Supervision and Management department belonging to State Administration. In 1988, GMP standards were issued by this department. Over the next years, new revised regulations were implemented. The latest GMP 2010 mainly concentrates on comprehensive quality control system. It is now mandatory for Chinese pharmaceutical manufacturing companies to have special administrative departments that have to ensure proper implementation of rules and regulations set in GMP 2010.

In the new Good Manufacturing Practice 2010 policy, some important improvements have been made. Now the qualification and expertise of the person entrusted with quality control has been clearly defined. The rules related to clean area system has been brought up to the same standards as applicable in EU countries. Certain rules related to safe and quality production of pharmaceutical products have been clearly established.

Comparing International GMP with the GMP of China:

While the Chinese GMP has adopted most of the requirements present in international GMP, some major differences still exist. One of the main differences is in the way a Chinese pharmaceutical company has to comply with its international GMP obligations to that of local GMP requirements. Local authorities are not properly equipped to ensure proper GMP compliance in China. This has resulted in quality problems.

The Chinese GMP implementation faces a number of difficulties. It is impossible for international observers to verify whether their Chinese pharmaceutical manufacturing company is complying with the GMP practices. Manufacturing approvals to these companies are given by the country\’s Food and Drug Administration department. Now, qualification requirements for employees and managers involved in production have been clearly established. They must have gone through certain training courses before they can be employed for their respective responsibilities.

When it comes to GMP compliance in China, the quality and management departments are separate entities in this country. This is quite different from the requirement as established in the international GMP. In the case of latter, annual product reviews are needed to ensure compliance of established processes. No such review is needed in the Chinese GMP. While it has clearly defined rules regarding where the manufacturing facility must be located, the Chinese GMP establishes only general rules for the administration of production and materials handling. It does not define specific requirements.

Electronic manufacturing is a solution to maintaining GMP compliance:

Importers of pharmaceutical products from China need to verify the authenticity of their Chinese manufacturers. They have to check whether these manufacturers are complying with the GMP regulations. A way to help is available using a cloud based manufacturing execution system. From the handling of raw material to maintaining proper electronic batch records on pharmaceutical products, this software helps maintain effective digital documentation and provides transparency to overseas operations.

Rick Soltero, President of InstantGMP MES, an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of http://www.InstantGMP.com MES, an electronic manufacturing execution system that is web based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Author Bio: Rick Soltero, President of InstantGMP MES, an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Category: Medical Business
Keywords: GMP Compliance, Dietary Supplements, Manufacturing Execution Software, Electronic Batch Record