GMP system certification rules
Scope of application: this rule applies to different scale, nature and type of health care products, food and drug enterprises to apply for GMP system certification
Certification mode: on-site audit + post-certification supervision
3 Certification process and certification time: 1) certification application 2) on-site audit 3) evaluation and approval of certification results 4) Post-certification supervision Note: On-site audit includes data technical review and on-site inspection. From the date of formal acceptance of the certification commission to the date of issuing the certification certificate, generally not more than 90 days, including on-site audit, certification results evaluation and approval and certificate production time.
4 certification application Scope division, certification based on standards, certification client to submit certification application, with the following documents and responsible for its authenticity: 1) written application; 2) To certify the business license and production license of the client; 3) Certification supervision contract; 4) The enterprise establishes and operates the management system in accordance with GMP;
5 site audit data technical review site audit
Evaluation of certification results and approval of the certification body on-site audit, audit conclusions for comprehensive evaluation. After passing the evaluation, the unqualified items shall be closed, and the certification body shall, in principle, send the certification certificate of GMP system to the certification client within 5 working days, in Both Chinese and English version, and the validity can be checked on the website of Certification and Accreditation Administration of China
7. Supervision after certification. Each supervision shall cover all manufacturing enterprises (sites) and cover the ISO9001 standard provisions. The content of supervision shall include: 1) the GMP system requires continuous conformity verification;
8 to expand or narrow the application. Within the validity of the certification certificate, the certification client needs to expand the scope of certification, product name and model before the next annual supervision and inspection, the annual supervision, the certification client should apply for procedures, certification bodies should evaluate the consistency of expanded products and original certification products, And the effectiveness of the original certification results for the expansion of content, at the same time according to the following requirements for on-site inspection: 1) for the need to expand the scope of certification before the next supervision and inspection, certification bodies should at least from the factory quality assurance ability supervision must check terms, GMP system evaluation requirements of two aspects of compliance is supplemented
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9 Certificate The validity period of the certificate is three years. The validity of the certificate is monitored periodically. If the validity of the certification certificate expires and needs to be extended, the certification client shall apply for extension within 90 days prior to the expiration of the validity of the certification certificate. The certification body shall issue a new certificate directly after receiving the extension application if the supervision result is qualified after the last certificate is obtained within the validity period.
10 Use of authentication identifiers. Through the certification and certification certificate of the enterprise can be certified in the product packaging body, nameplate, packaging, attached documents (such as manual, certificate, etc.), operating system, electronic sales platform and other locations to use or display.
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Editor in charge：Shanghai Yue Fei Enterprise Management Consulting Co., Ltd.
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