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¡Á817¡¢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. |
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