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Processing Authority: Drug Safety Supervising Department of Shanghai Drugs
Administration Bureau
Processing Procedures:
I. Application
1. When applying for GMP
certification, the drug manufacturers should submit the following documents to
Shanghai Drugs Administration Bureau:
(1) Application Letter of Drug GMP
Certification
(2) Xerox copies of License of Drug Production and Business
License for Incorporated Enterprise
(3) Self assessing on drug production
administration and quality administration (including basic information of the
manufacture, its history, production and quality administration information,
rectification situation of unqualified item in last certification);
(4)
Organization chart of the drug manufacturer (provide clear indication of the
name of each departments, relationship between each other, principal of each
departments);
(5) Resume of the principals of the manufacturer and each
departments; registration form of the experts, technicians, and skilled workers
that are certified by relevant authorities, and indicated their positions and
departments; the ratio of professional technician, senior technician, and junior
technician among total employees;
(6) Form of all the species of products
manufactured by the enterprise; form of the products applied for GMP
certification (indicated long-term production species), including product
standards, production approval number; xerox copies of new drug certificate and
production approval certificate and other relevant documents;
(7) Around
environment graph of the enterprise, overall layout drawings, storage layout
drawings, quality inspecting field layout drawings;
(8) Brief information
about the producing workshop and its technical layout drawings (including
Changing Room, Lavatory, alleyway for employees and goods, air break, etc., and
indicate the flow direction of people and goods, and clear level of the air);
layout drawings of the blowing, air returning, and exhausting of the air
purification system; layout drawings of technical equipments;
(9) Technical
work flow of the product species applied for GMP certification, and indicated
major processing control points and control items;
(10) Assessing information
of the key working procedure, major equipment, watering system, and air
purification system of the manufacturer (or workshop); assessing information of
the detecting equipments and facilities;
(11) Documents list of production
management and quality management of the manufacturer (or workshop).
2. Drug
Safety Supervising Department will fill in the GMP Certification Application
Acceptance Notice. The notice has two copies, one for the applicant, and one for
the Drug Safety Supervising Department.
3. Drug Safety Supervising Department
will have modal examination (including policy examination) on the integrity of
application documents, and provide opinion within 5 working days after receiving
the complete documents. The qualified application will be forwarded to Shanghai
Drugs and Medical Equipment Appraising Center. For the unqualified application,
the applicants will be notified to supplement related documents, and recalculate
the time limit since the re-applying day.
II. Technical documents examining and spot-inspecting plan constituting
1.
The appraising center should finish the technical examination on the application
documents within 20 working days.
2. After the technical examination, if the
applicant need supplement documents, the appraising center should issue written
notice to the applicant. The applicant should supplement related documents
within 2 months after receiving the written notice. The time limit will continue
calculation after supplementing the documents. For applicant who is overdue, the
certification work will stop.
3. The appraising center need make spot
inspecting for the applicant who passes the document examination, according to
the species of the applied product. The spot inspecting plan need include
schedule arrangement, inspecting item, team member and individual tasks. The
appraising center will take the responsibility of issuing spot inspecting notice
to the applicant, and forward the notice to local drug administration bureau,
entity where team member comes from, and Drug Safety Supervising
Department.
4. The member of the spot inspecting team should be Shanghai
inspectors from GMP certification inspector database of State Drugs
Administration Bureau. 1 team leader and several team members will be picked
randomly. Yet inspector from local drugs administration bureau where the
applicant locates should be avoided. Shanghai Drugs Administration Bureau or
local drugs administration bureau where the applicant locates can dispatch 1
observer to join the certification inspecting.
III. Spot inspection and integrative appraisement
The spot inspection
should be organized for the applicant who passes the technical examination
within 20 working days after the technical examination is finished.
1. The
team leader will in charge of the spot inspection.
2. The first meeting will
be presided by team leader to introduce team members, announce disciplines,
explain notice items, confirm inspecting scopes, put schedule into effects, and
make certain about the accompanying staff. The team member should show the
National Drug GMP Certification Inspector Certificate to the applicant.
3.
The team member should carry through comprehensive inspections on the inspecting
items according to the inspecting plan, and get attestation when
necessary.
4. The inspector should make accurate records of the unqualified
item according to the GMP certification inspecting plane and appraising
standards.
5. The inspecting team should publicize the unqualified items in
the last meeting. The applicant can arrange corresponding staff to attend the
meeting, and provide different opinion or make explains and illustrations on the
unqualified items.
6. The unqualified items found during the inspection
should be signed by all the team members and principals of the inspected entity,
and one copy for each part. For the question that can not reach a conjunct idea,
the team shall make records and signed by all the team members and principals of
the inspected entity, and one copy for each part. The inspected entity has the
right to submit written report with different opinions to the Shanghai Drugs
Administration Bureau within 5 working days.
7. The team leader will organize
to collect the appraisement and compose spot inspecting report. The inspecting
report should be signed by all the team members, and relevant documents as
unqualified items, inspector records, and opinions on dissidence should be
attached.
8. The time for spot inspection would be 2 to 4 days normally, and
can be adjusted according to the individual situation of the enterprise.
9.
The appraising center will organize integrate appraising meeting of GMP
certification to audit the spot-inspecting reports, and form integrative
appraising opinion.
IV. Audit and proclaiming
1. The Drug Safety Supervising Department of
Shanghai Drugs Administration Bureau will audit the integrative appraising
opinions and other relevant documents, report the auditing opinion to the bureau
leader for approval, and make decision of passing GMP certification or not. The
time for the auditing and approving is 10 working days.
2. For the drug
manufacturer (or workshop) that approved to meet the certification standards,
Shanghai Drugs Administration Bureau will report to State Drugs Administration
Bureau for proclaiming.
3. For the drug manufacturer (or workshop) that does
not meet the certification standards, Shanghai Drugs Administration Bureau will
issue notice of rectification in a limit time to the inspected entities, and the
rectification time is 6 months. After finish rectification within the limit time
period and submit rectification report, the appraising center will dispatch
inspecting team to the qualified applicant again.
4. For the applicant who
passes the re-inspection, Shanghai Drugs Administration Bureau will report to
State Drugs Administration Bureau for proclaiming.
5. For the applicant who
fails in the inspection again, Shanghai Drugs Administration Bureau will issue
notice of unqualified in the GMP certification.
V. Certificate issuing
Shanghai Drugs Administration Bureau will issue
Drug GMP Certificate to the enterprise with no dissidence 10 days after the
proclaiming of State Drugs Administration Bureau. The time limit for issuing
certificate is 5 working days.
Processing Address: Room 1102, No. 189 Pu-An Road
Processing Basis:
Drug Administration Law of People's Republic of
China
Rules of the Implementation of Drug Administration Law of People's
Republic of China
Administrating Regulations on Quality Managing Criterion
Certification of Drug Production
Contact Tel: 021－63879380
Processing Time: Monday to Friday 9:00 a.m.－11:30 a.m.
Time Limit for Processing:
Model examination for accepting application 5
working days
Documents examination and spot-inspecting plan making 20 working
days
Spot Inspection and integrative appraising 20 working days
Auditing
and approving 10 working days
Proclaiming 10 working days
Certificate
Issuing 5 working days
Qualification of the applicants:
1. New-opened drug manufacturers or the
new-increased producing scope of drug manufacturers
2. The established drug
manufacturers
3. The new-established, restructured, or extended workshop (or
product line) of drug manufacturers, or new production scope that need
certification
4. The initial GMP certification application of the enterprise
producing injections, radioactive drugs, and biology products prescribed by
Stated Drugs Administration Bureau does not fall into this regulation.
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