The difference between GMP and ISO9000 and the significance of its implementation

The main purpose of formulating and implementing GMP is to protect the interests of consumers and ensure that people's medicines are safe and effective; at the same time, it is also to protect drug production enterprises, so that enterprises have laws and regulations to follow; in addition, the implementation of GMP is a government and law. Given the responsibility of the pharmaceutical industry, after China's accession to the WTO, the need to implement a drug quality assurance system, because if a drug manufacturer fails to pass GMP certification, it may be rejected from the technical barriers to international trade. Differences between GMP and ISO9000: 1. GMP is a general guideline for national drug production quality management, and IS09000 is a standard system for quality management and quality assurance promulgated by the International Organization for Standardization (ISO). 2. GMP is regional, and most countries formulate their own GMPs based on their own national conditions, which are only applicable to the pharmaceutical production industry. The ISP9000 quality system is an international quality system, which is not only applicable to the production industry, but also to the service, management, finance and other industries, so it is more extensive. 3. GMP is a special and mandatory standard. The GMP of most countries or regions has legal effect, and its implementation is mandatory, and its provisions shall not be added or deleted. The promotion, implementation and implementation of ISO9000 are based on the voluntary basis of enterprises, and certain elements can be selected, deleted or supplemented. The implementation of GMP is not only a concrete manifestation of the effective and highly responsible spirit of drug production enterprises for the safety of people's medication, but also an important symbol of the enterprise and an important guarantee for the competitiveness of enterprises and products. It is in line with international standards and enables pharmaceutical products to enter the international market. Therefore, it can be said that GMP standards are the basis for the survival and development of pharmaceutical manufacturers, and GMP certification is the 'entry permit' for products to lead to the world. The verification of GMP is also very strict. When choosing a company with practical operation experience, like Zhongshan Kenwei Precision Machinery Co., Ltd. has rich experience in GMP whole plant planning in the industry.