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6. Procedures
6.1 Application for Change: The department applying for change
will fill in the application-for-change box on the "Application
for Changes/Notice on the Results of Deliberations" (P1/7)
indicating the purpose of change, contents of change and other
necessary items, then submit it to the Standing Organ for
Changes (QA Department) for review, the Standing Organ for
Changes will in turn make an initial judgment as to the degree
of the change before submitting it to the Director of the
Change Control Committee for verification and approval.
6.2 Identification of
Items in Drug Administration and Protocol: the Standing Organ
for Changes (QA Department) will make an initial judgment
on the contents of the proposed change; if necessary, formulate
such documents as "Verification of Drug Administration
Items" (P2/7) and "Verification of Protocol Items"
(P3/7).
6.3 Conventions of the
Change Control Committee
6.3.1 Conventions of the Change Control Committee will be
organized by the Director of the Change Control Committee.
6.3.2 Attendants: responsible persons for quality control,
responsible persons for related verifications, and those related
persons designated by the Standing Organ for Changes based
on the instructions from the Director of the Change Control
Committee.
6.3.3 The Change Control Committee will deliberate on the
Application for Changes, the information provided by the department
applying for change, the Verification of Drug Administration
Items, and the Identification of Protocol Items, identify
the contents of research on the change and the items for evaluation,
identify the department responsible for the change, and arrange
for schedules. The Standing Organ for the Changes (QA Department)
will formulate the "Deliberation Record by the Change
Control Committee".(P4/7)
6.3.4 The Standing Organ for Changes will fill in the deliberation-result
notification section on the "Application for Changes/Notice
on the Results of Deliberations" (P1/7) with conclusions
by the Committee, then take on the liaising job after approved
by the Director of the Change Control Committee. In addition,
this notice will be attached with such related documents as
the Identification of Drug Administration Items, the Verification
of Protocol Items, and the Deliberation Record by the Change
Control Committee, etc.
6.3.4.1 If a reapplication is considered necessary after the
deliberations by the Change Control Committee, the original
applicant should be notified to resubmit his application for
change.
6.3.4.2 When the change is approved after the deliberations
by the Change Control Committee, the Standing Organ for the
Changes (QA Department) will issue the Approval for Change.
6.3.4.3 When the quality verification is considered necessary
after the deliberations by the Change Control Committee, the
related department responsible for test should be notified.
6.3.4.4 When the implementation of test and verification is
considered necessary after the deliberations by the Change
Control Committee, the test-verifying organ should be notified
to carry out the tests and verifications.
6.3.4.5 When a research on the change is considered necessary
after the deliberations by the Change Control Committee, the
RP (Responsible Person) of the department to take on the change
should be notified to formulate the "Plan for the Research
on the Change" (P5/7), to be submitted to the Director
of the Change Control Committee via the Standing Organ for
the Changes (QA Department), and to be further submitted to
the Responsible Deputy GM and Production Supervisor (QA) for
approval, after being checked by the Director for its appropriateness.
6.4 Implementation of
Research on Change
6.4.1 The RP of the department to take on the change will
carry out the research on the change in accordance with the
plan for the research on the change (including test and verifying
of change, quality verification tests or other researches).
The outcome of the research on the change will be written
down in the "Results of the Research on the Change/Notice
of Results of Evaluation on the Change" (P6/7), to be
submitted to the Director of the Change Control Committee
via the Standing Organ for the Changes (QA Department).
6.5 Evaluation of the
Results of Research on Change
6.5.1 The Director of the Change Control Committee will organize
the meetings of the Change Control Committee, evaluate and
confirm the results of research into change. The Standing
Organ for the Changes (QA Department) will fill in the "Results
of the Research on the Change/Notice of Results of Evaluation
on the Change" (P6/7) with conclusions by the Committee,
notify the department to take on the change or any related
department, and submit it to the Responsible Deputy GM and
Production Supervisor (QA) for checking and approval.
6.6 Approval for Change
6.6.1 For the change that belongs to Degree 3, the Standing
Organ for Changes (QA Department) will issue the Approval
for Change, which may be implemented right after the approval
by the Production Supervisor (QA).
6.6.2 Change that belong to Degree 1 or 2:
6.6.2.1 If the change requires no ratification, filing or
prior approval from the State administration or other statutory
entities or protocol, and if it is considered feasible after
deliberations by the Change Control Committee, the Standing
Organ for Changes (QA) will issue the Approval for Change,
have it countersigned by the Director of the Change Control
Committee, and submit it to the Production Supervisor (QA)
for approval.
6.6.2.2 If the change does require ratification, filing or
prior approval from the State administration or other statutory
entities or protocol, the Standing Organ for the Changes (QA
Department) will submit it to the QA Department or related
department for confirmation; after it is ratified or approved,
the Standing Organ for Changes (QA Department) will issue
the Approval for Change, have it countersigned by the Director
of the Change Control Committee, and submit it to the Production
Supervisor (QA) for approval.
6.6.3 The Standing Organ for Changes (QA Department) will
notify the department responsible for change and related department
in accordance with the Approval for Change and the contents
of change.
6.7 Revision of Related
Documents and Training and Education: While implementing the
change, the department responsible for change will revise
or supplement related documents as needed, and carry out education
and training on change while making notes.
6.8 Formulation of Change
Application Numbers
6.8.1 The Standing Organ for Changes (QA Department) will
take on the responsibility to number the application for change.
The formulating methods for numbering the application for
change are as follows:
Based on solar calendar, the last two digits of the year +
month + day -- 01-99 (the sequence number for the applications
on the same date).
For example: the third application on September 5, 2002 will
be numbered as "020905—03".
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