Application for GSP Certification of Pharmaceutical Operation Enterprises in Sha

[2008-12-23 16:54:10]

Processing Authority: Circulation Management Office under Shanghai Food and Drug Administration

Processing Procedures:

(I) Application and Acceptance

1 Any and all of pharmaceutical operation enterprises applying for the GSP certification shall fill in the Letter of Application for Drug Good Supply Practice (GSP) Certification (in duplicate, see attached Table I for format) and present any and all of materials as follows:

(1) the xerox copies of the License of Drug Operation and Business License respectively;

(2) the self-check report of implementation of GSP in the enterprise;

(3) the profiles of the key officers and quality management personnel of the enterprise (see attached Table II for format);

(4) the profiles of the personnel responsible for drug inspection before acceptance and conservation of the enterprise (see attached Table III for format);

(5) the profiles of the business operation places, and facilities and equipments of storage, inspection before acceptance, and conservation of the enterprise (see attached Table IV for format);

(6) the profiles of the affiliated drug operation entities of the enterprise (see attached Table V for format);

(7) the catalogue of the file system of the drug operation quality management of the enterprise;

(8) the block diagram of configuration and functions of management organization and institutions of the enterprise; and

(9) the plane layout of the business operation place and warehouse of the enterprise.

2 The authority of acceptance (GSP Certification Office shall be responsible for acceptance of application for GSP certification by the drug wholesale/retail chain enterprises; and the competent local food and drug sub-administration at district/county level shall be responsible for application for GSP certification by the drug retail enterprises) shall conduct the due format review of materials necessary for such application, accept those applications with complete materials that are complying with requirements, and issue the notice of acceptance. The competent local food and drug sub-administration at district/county level shall, within 3 working days upon completion of the said format review, report those materials necessary for certification and the opinion of the format review to GSP Certification Office which shall, within 20 working days upon acceptance, complete the technical review, and, in case of failure or question in such technical review, inform the very applicant to supplement materials or specifications subject to the requirements within 20 days where the technical review is suspended. In case requirements cannot be reached even upon the day when the term of supplementing materials falls due, the report shall be presented to the key official of GSP Certification Office for review and approval of discontinuing the technical review with a notice in writing to the very applicant with causes.

(II) GSP Certification Office shall, within 15 working days upon completion of the said technical review, organize the field inspection with a notice in writing 3 days prior to such survey to the very applicant and the local food and drug sub-administration which governs the place where the applicant is located.

1 GSP Certification Office shall organize a field inspection team with composed of 1 leader and 2 members from the municipal GSP inspectors base in a manner of random selection.

2 The inspection team shall conduct inspection subject to the Procedures of GSP Certification Filed Inspection formulated by State Food and Drug Administration and the standard for GSP certification field inspection for a period of 2 or 3 days, and, within 2 working days upon completion of the field inspection, present the filed inspection report and materials to GSP Certification Office.

3 The very applicant shall, upon completion of the filed inspection, make the plan and measures for correction of defects and issues detected in the GSP certification, and report to GSP Certification Office in due course of time.

4 GSP Certification Office shall, within 5 working days upon receipt of the filed inspection report and materials presented by the inspection team and subject to the standard for GSP certification, bring out the opinion of the due review of GSP certification, and report to Circulation Management Office under Shanghai Food and Drug Administration with other necessary summary materials.

(III) Review and Issue of Certificate

Circulation Management Office under Shanghai Food and Drug Administration shall, within 15 working days upon receipt of opinions of review by GSP Certification Office and other required materials, bring out its opinion of review, and the key official of Shanghai Food and Drug Administration shall, within 5 days upon receipt of opinions of review by Circulation Management Office and other required materials, make the decision of approval or not.

1 Shanghai Food and Drug Administration shall issue the Certificate of Drug Good Supply Practice Certification to the enterprise qualifying the standard for GSP certification, and make public announcement.

2 Shanghai Food and Drug Administration shall inform the enterprise who is subject to correction in due course of time in writing with causes, and, at the same time, send a duplicate copy of the notice to the competent local food and drug sub-administration which governs the place where the very enterprise is located. The enterprise shall, within 3 moths upon receipt of notice, present the report of correction and application for re-review to GSP Certification Office which shall, within 15 working days upon receipt of such application for re-review, organize a new inspection team to conduct a field re-inspection.

3 Shanghai Food and Drug Administration shall issue the notice of certification failure to the applicant being rejected for review, or failing to present the application for re-review before the deadline of the term for correction, or failing to pass the field re-inspection, who can, within 6 months upon receipt of the said notice , re-apply for GSP certification.

Processing Address: 1. GSP Certification Office responsible for application for GSP certification of drug wholesale enterprises or drug retail chain enterprises is at No. 1399, Huashan Road, Shanghai, and the telephone is 021-62830955 (service reception), or 63872492, or 62837766×817、821 (office).

2. the local food and drug sub-administration at district/county level (see attached VI for detailed addresses and telephones)

Processing Time: Mondays through Thursdays: 9:00~11:30 and 13:00~16:20

Fridays: 9:00~11:30

Processing Basis:

1. Pharmaceutical Administration Law of the People's Republic of China under No. 45 Presidential Order of the People's Republic of China;

2. Regulations of Implementation of Pharmaceutical Administration Law of the People's Republic of China under No. 360 Order of State Council;

3. Regulations on Drug Good Supply Practice under No. 20 Order of State Food and Drug Administration;

4. Detailed Rules for Drug Good Supply Practice under Guo Yao Guan Shi [2002] No. 526 of State Food and Drug Administration;

5. Measures for Administration of Drug Good Supply Practice (GSP) Certification (for trial implementation) under Guo Yao Guan Shi [2002] No. 527 of State Food and Drug Administration;

6. Notice on Determination of Issues Related to GSP Certification under Guo Yao Jian Shi Han [2002] No. 65 of State Food and Drug Administration;

7. Notice on GSP Certification under Guo Yao Jian Shi [2002] No. 488 of State Food and Drug Administration

8. Measures of Shanghai Municipality on Administration of Drug GSP Certification (for trial out in selected enterprises) under Hu Yao Jian Liu Tong No. 230

Qualified Application Subject:

Scope of Application:

Any and all of drug wholesale, retail chain, and retail enterprises possessing the License of Drug Operation issued by Shanghai Food and Drug Administration and the competent local food and drug sub-administration and applying for GSP certification.

Qualification of Applicant:

Any and all of drug operation enterprises

1. that have the status of incorporated enterprise, or that are affiliated to the non-exclusive drug incorporated enterprises;

2. that have obtained the License of Drug Operation and Business License; and

3. that have met conditions and requirements of the Drug Good Supply Practice and the detailed rules for implementation whereof after the internal self-check.

Source: 上海市人民政府

Keywords:Quality Supervision

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