GMP certification is the embodiment of total quality management in the pharmaceutical industry, << the Chinese people*** and the State Standardization Law Implementation Regulations>> Article 18 provides: "National standards, industry standards are divided into mandatory standards and recommendatory standards". And drug standards are mandatory standards.?
GMP certification is a set of software, hardware, safety, health, environmental protection in one of the mandatory certification, then it must establish and operate a scientific, recognized international management system;
To ask the second party (consulting agency) with qualifications together with the experts in the enterprise for the overall planning, assessment, the development of a suitable for the enterprise (including international standards, national standards, industry standards) specifications The quality management manual and operating instructions, in the learning, training, operation of the continuous correction process, and then apply for GMP certification is a wise choice for each pharmaceutical industry.
Expanded Information:
A, responsibilities and authority:
1, the State Drug Administration is responsible for the national drug GMP certification. State Drug Administration Drug Certification and Management Center (hereinafter referred to as "Pharmaceutical Certification Center") to undertake the specific work of drug GMP certification.
2, provinces, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the jurisdiction of the drug manufacturers of pharmaceutical GMP certification declaration of the initial review and daily supervision and management.
Second, the certification application and data review:
1, the applicant shall be located in the province, autonomous regions and municipalities directly under the Central Drug Administration to submit the "application for GMP certification of pharmaceuticals", and in accordance with the "Drug GMP Certification Management Measures" at the same time to submit the relevant information.
Provinces, autonomous regions, municipalities directly under the Central Drug Administration shall receive the application information within 20 working days from the date of application materials, application materials for preliminary examination, and will be the preliminary examination of the views and application materials sent to the State Drug Administration Division of Safety Supervision.
2, certification application materials by the Department of Safety Supervision acceptance, form review, forwarded to the certification center.
3, the Bureau of Certification Center received the application materials, application materials for technical review.
4, the Bureau of Certification Center should be received in the application information within 2O working days from the date of the review, and notify the applicant in writing.
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