How much does GMPC certification cost and how long does it take to certify GMP

It is different from place to place, generally around 5w.

Certification GMP takes 75 working days.

The time process of GMP certification: the drug safety supervision department of the provincial bureau will review the form of the application materials (5 working days).

The certification center conducts a technical review of the application materials (10 working days), and the certification center formulates an on-site inspection plan (10 working days).

Provincial bureau approval plan (10 working days).

The certification center organizes and implements the on-site inspection of certification (10 working days), the certification center conducts a preliminary review of the on-site inspection report (10 working days), the provincial bureau examines and approves the preliminary review opinions of the certification (10 working days), and reports to the national bureau for a review announcement (10 working days).

GMP certification is a certification to be carried out by a company, especially pharmaceutical companies, skin care companies, and other enterprises that have regulations on the production and manufacturing workshop. GMP certification process is quite a lot of processes, the company must go to the provincial bureau of the region to submit an application for processing, in which the key step is to inspect on the spot, the certification management center will have some people come out to the enterprise company to check all kinds of conditions.

GMP is an abbreviation for goods manufacturing practice. The World Health Organization defines it as a regulation that governs the production and quality management of food, medicines, and medical products.

GMP is a mandatory standard applicable to the pharmaceutical, food and other industries, requiring raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control, etc. to meet the requirements of hygiene and quality, and to form and improve the operation specifications that can be manipulated and buried.

On July 11, 1995, the Ministry of Health of the People's Republic of China issued Wei Yao Fa (1995) No. 35"Notice on carrying out drug GMP certification"。Drug GMP certification is a system in which the state implements GMP supervision and inspection of drug manufacturers (workshops) and drug varieties in accordance with the law and obtains recognition.

According to the provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China, the provincial drug regulatory department shall be in accordance with the "Good Manufacturing Practice for Drugs" and the implementation measures and implementation steps of the drug regulatory department for the certification of drug manufacturers; A certificate of certification will be issued if the requirements are met. Among them, the certification of drug manufacturers producing injections, radiopharmaceuticals and biological products specified by the drug regulatory department shall be responsible for the certification of the drug regulatory department. [1]

As one of the types of medical device quality management system, one of the basic conditions for enterprises applying for certification is that enterprises must establish and operate the system for 3-6 months to provide the organization with the resources, capabilities and records to operate the GMP system. Therefore, it takes 3-6 months for a company to apply for GMP certification from establishment.

GMP certification is based on the United States**, commonly known as QSR820 or GMP820, this quality system specification contains the requirements for the current GMP, the requirements mentioned in this specification are to control the design, production, labeling, storage, assembly, maintenance services and equipment and control methods used in all finished devices for the human body. The requirements set forth in this specification are mainly to ensure the safety and effectiveness of the finished device, and at the same time to comply with the Food, Drug and Cosmetic Code (hereinafter referred to as the specification).This specification establishes the basic requirements applicable to manufacturers of finished devices.

If a lifetime product involves only a part of the requirements of this specification and nothing else, then the manufacturer only needs to meet the requirements of the field referred to in this specification. In the case of Class I devices, it is designed to work with the 820 only

Those listed in Section 30(a)(2).

This specification does not apply to manufacturers of finished device components or components, but such manufacturers are encouraged to use the appropriate provisions of this specification as a guide. Manufacturers of artificial blood and blood components are not included in this section, but should be included in section 606 of this chapter on hail control.

During the technical review, the fee for accepting the application fee is 500 yuan per enterprise;

Organize experts to apply for drug GMP certification for the production of injections, radiopharmaceuticals and biological products specified by the drug regulatory department to conduct on-site inspection and audit of the enterprise to charge the audit fee, the charging standard is a dosage form (including a production line) 30,000 yuan, each additional dosage form can be charged 3,000 yuan. Abolish the annual fee charged by the National Center for Drug Certification and Administration to enterprises that have obtained GMP certificates. The provincial drug certification management institutions of the provinces, autonomous regions and municipalities directly under the Central Government shall carry out GMP certification for other drug manufacturers within their jurisdictions, and charge the GMP certification fee (including the acceptance application fee and audit fee) to the applicant enterprise, which shall be formulated by the price department of the province, autonomous region and municipality directly under the Central Government where the enterprise is located in conjunction with the financial department, on the basis of the fee standard lower than that of the National Drug Certification Administration Center, and shall be reported to the National Development and Reform Commission and the Ministry of Finance for the record.

Cosmetics GMPC certification originated in the United States at the earliest.

In the United States, in 1962, the cosmetics GMPC legislation has been enacted, clearly stipulating that "drugs and cosmetics shall be safe and effective in accordance with the law and have appropriate labeling (including labels and instructions for use, ***, precautions and other correct contents, and shall not be adulterated)", and later by the US Food and Drug Administration (FDA) specifically to prohibit the promotion or pyramid marketing of counterfeit or unbranded cosmetics in the United States between continents ** and formulated the "Guidelines for Cosmetics Manufacturing Activities" (i.e., GMPC, A portion of the excerpt from the FDA Inspection Manual, currently the 2008 version of the standard).

In the early 90s, the Commission of the European Communities also formulated the "Good Manufacturing Practices for Cosmetic Products--- the Health Protection of Customers" (abbreviated as GMPC, currently the 1995 version of the standard) for cosmetics, and then made some improvements on the original basis, with the aim of ensuring the safety of consumers as the starting point, with the intention of promoting the protection and understanding of the use of perfect standards and guidelines among member states, and promoting greater economic harmony among member states of the European Community. So that their economy and society continue to progress, and the people's life is more satisfying.

Today, the International Organization for Standardization (ISO) has also launched the cosmetics standard "ISO22716" as the Golden Globe Cosmetics Standard.

In our country (China) there are no such strict requirements for the time being, but the development trend will inevitably move towards cosmetics GMPC (this year China has been drafting China GMPC), because the implementation of GMPC makes enterprises have a solid guarantee for providing stable and reliable quality products; Previously, our country has established the "State Food and Drug Administration", and the corresponding provincial and municipal food and drug administrations have been established at all levels, and the safety supervision and daily management of cosmetics have also been assigned to the unified management of the cosmetics department of the bureau; According to the information, after the completion of the GMP certification of drugs and health foods, the relevant departments are ready to start formulating GMPC standards for cosmetics in order to cope with the WTO, strengthen the regulatory functions of China's cosmetics import and export (including "OEM, ODM" cosmetics) after joining the WTO, and ensure the safety and health of consumers.

The applicant shall submit the Application Form for Drug GMP Certification to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government, and submit the relevant information at the same time in accordance with the provisions of the Administrative Measures for Drug GMP Certification.

The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 20 working days from the date of receipt of the application materials, conduct a preliminary review of the application materials, and submit the preliminary review opinions and application materials to the Safety Supervision Department of the State Drug Administration.

The certification application materials shall be accepted and formally reviewed by the Safety Supervision Department of the Bureau, and then transferred to the Certification Center of the Bureau. If there is a problem on which consensus cannot be reached, the inspection team shall make a record, and after all members of the inspection team and the person in charge of the unit being inspected sign it, both parties shall hold a copy.

GMPC Key Features:

GMPC proposes a revolutionary hybrid chain architecture, independently develops GMPC BFT innovative consensus mechanism, integrates the pan-POS staking ecology, and realizes the "multi-chain-relay chain-cross-chain" fusion chain protocol interaction and hybrid storage.

1. Revolutionary hybrid chain architecture.

2. Support interconnection between cross-chains and alliance chains.

3. The "engine engine" of global blockchain value flow.

To discuss the above content refer to the encyclopedia—gmpc