STANDARD OPERATING PROCEDURE CHANGE CONTROL SYSTEM FOR WYETH
STANDARD OPERATING PROCEDURE
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SUBJECT :
CHANGE CONTROL SYSTEM FOR WYETH |
DEPARTMENT : QA
SOP
NO. :
Page
No :
Effective
Date :
Next
Review :
SOP
REVISION :
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1.0 OBJECTIVE:
1.1 To
establish requirements for control of any changes in specifications,
instruments, analytical methods, equipment, manufacturing and packaging
operations, suppliers, documents which have potential impact on product safety,
identity, strength, quality, purity, stability or validated state and to
identify the items which shall be subject to such control.
2.0 POLICY:
2.1 Change control is a formal procedure to
2.1.1 Ensure through appropriate evaluation that any change made will
not adversely affect the quality of validation status of the materials,
equipment and procedures.
2.1.2 Ensure that the change is properly
documented.
2.1.3 Ensure
that if changes were having any impact on regulatory compliance then F. D. A.
approval would be required to be sought prior to implementation of change.
3.0 PROCEDURE:
3.1 This
change control system shall apply for controlling, authorization, approvals,
amendments and implementation of changes pertaining to but not limited to the
following;
3.1.1 Raw materials, starting materials,
intermediates and packaging components used in the products.
3.1.2 Manufacturers
and distributors of the above items.
3.1.3 Manufacturing
formulas.
3.1.4 Manufacturing
and packaging processes.
3.1.5 Master
batch records and master packaging records.
3.1.6 Labels
and labeling.
3.1.7 Primary
container/closure systems and packaging configurations.
3.1.8 Equipment
used in manufacturing, packaging and testing.
3.1.9 Utilities
(e.g. Air, water, nitrogen, compressed gases) used in or in support of
manufacturing, packaging and testing functions.
3.1.10 Computerized and automated systems used for GMP related purposes
(including distribution operations, and inventory management).
3.1.11 Calibration and maintenance procedures and
schedules.
3.1.12 Cleaning and sanitation procedures for direct contact equipment and
selected non-contact surfaces and areas.
3.1.13 Tests methods and specifications (analytical, microbiological,
biological and cleanliness verification tests).
3.1.14 Emergency
changes.
3.1.15 Like for like
changes.
3.2 RESPONSIBILITY
3.2.1 The Site Change Control Committee is
responsible for the approval of all change control requests.
3.2.2 The
change control procedure requires that a formal change control request to be
filled by the division/department initiating the change
3.2.3 The site
change control committee will have the authority to approve and implement the
change control proposals
3.2.4 The site
change control committee will consists of representatives of QA, Production,
Maintenance & Stores.
3.2.5 After
the approval of the change control request by the site change control
committee, the division/department initiating the change control request will
be responsible for implementation of the approved change along with the site
Quality Assurance department.
3.2.6 Q. A.
will be responsible for allocating unique change control request number to each
change control request. The site Q. A. will be responsible to keep a record of
each change control request and the unique change control request number
allocated to such request.
3.2.7 Q. A.
will be responsible for tracking each change control request with respect to
its implementation.
3.2.8 Q.A is responsible for tracking and tending
the parameters impacted by the change.
3.2.9 Q. A. is responsible for tracking and
trending the parameters impacted by the change.
All the change control requests duly documented will
be maintained by Q. A.
3.3 Emergency
changes:
3.3.1 Emergency change requests should be
infrequent and should be requested under extenuating circumstances only.
3.3.2 Q. A. Manager or designee is authorized to
give approval for the emergency changes. The same has to be documented by the
initiator. Only after approval, the emergency changes may be carried out.
3.3.3 Even if the change is of temporary nature or
is a one-time change, the change control form needs to be filled. The change
control form must be filled within the first working after the approval.
3.3.4 If any emergency change results in situation
requiring investigation, than reference to the investigation must be mentioned
in the change control form.
3.3.5 If the emergency change has impacted the equipment or process in
critical manner, than the product/material may need to be quarantined till such
time appropriate validation/stability or any such studies are carried out.
3.4 Temporary
changes:
3.4.1 It is necessary to fill a change control
form for all the temporary changes.
3.4.2 All temporary changes need to have the
approval of change control committee.
3.4.3 The change control form needs to be suitable
marked to indicate that the change is temporary.
3.4.4 A targeted expiration date for the change should also be suitably
marked on the change control form.
3.4.5 Conversion of temporary change to permanent change is allowed.
However, a new change control form needs to be filled. The new form should give
the reference of the temporary change control form.
3.4.6 Appropriate supporting documentation proof
is necessary to justify the change in the status.
3.4.7 The
change control committee, under certain circumstances as seen appropriate by
it, may delegate certain function of a change control request to a
sub-committee. It is not necessary that the sub-committee head or its members
belong to change control committee. However, the change control committee has to
provide necessary guidance to the sub-committee for its proper functioning.
Change control committee has the final responsibility for the sub-committee.
3.4.8 Like-for-Like: Instruments or parts that perform the same function, have the same
performance characteristics/specifications, but may be produced by different
manufacturer or may be a replacement part by the same manufacturer. These may
be approved for use as replacement instruments or devices if the validated
state is not altered.
3.5 GENERAL PROCEDURE
The proposal for the change will be initiated by the
concerned department/initiator and forwarded to the change control committee on
the prescribed form (WLL/REC/CHANGE) for approval (Attachment 1). The
initiator/initiating department must submit the change control form along with
the supporting documents and also ensure that all the appropriate sections are
filled in by the initiator/initiating department before it is submitted to the
change control committee
The changes may be classified as;
3.6 Major change
3.6.1 Any
change to the material, equipment or procedure that may have a significant
impact on the process or product.
3.6.2 Any
change which requires testing, acceptance and that which may require approval
of regulatory body (e.g. F. D. A.) before implementation.
3.6.3 A new product introduction Line extension to
an existing product.
3.6.4 A change
in manufacturing site, which involves changes in the formula, manufacturing
procedure, equipment and Q. A. testing.
All
these changes will be first approved by the site change control committee. If
the change control committee deems it necessary than the change control request
will be sent to Wyeth Q.A. (International) for approval/comments. After the
approval/recommendation by Wyeth Q.A. (International), the changes as specified
in the change control request will be implemented.
3.7 Other changes
3.7.1 Any change in the equipment, materials or
procedures that will have no significant impact on the process or product.
3.7.2 Any change that requires documentation, and
may be implemented immediately upon approval
3.7.3 Change
in general procedure for working in manufacturing area and laboratories
3.7.4 Change
in processing step of a manufacturing process
3.7.5 Change
in the manufacturing and laboratory equipment and instrument
3.7.6 Change
in the text or colour of printed packaging material
3.7.7 Change in the in-house specification of raw
materials, in-process intermediates and finished product specifications
3.7.8 Change
in the test procedure/method of analysis
3.7.9 Change
in the SOPs related to manufacturing, packaging and laboratories
3.7.10 Change in
the location of equipment/instruments
3.7.11 All the
above mentioned minor changes will be approved by the site change control
committee only.
3.7.12 In case of like for like replacement, a change
control form needs to be filled. The change
committee must approve the change control form before initiating the
action. The change after implementation will need to be qualified
(Installation, Operation and Performance).
3.7.13 If the change control is approved by the site
change control committee, the initiating division/department will then
co-ordinate the implementation of the change according to the condition stated
in the approved change control request.
3.7.14 All the
documents affected by the change will be reviewed and revised accordingly by
Q.A.
3.7.15 The Q. A
will duly maintain change control requests.
3.7.16 Equipment, instruments and the associated
processes and/or procedures and documents must not be altered, enhanced,
modified or substituted without following the change control system.
3.7.17 The site change control committee using the
change control request will approve any amendment to the site change control
procedure.
3.7.18 Q. A. to ensure the effectiveness of the
change must track the change control for appropriate time. Q. A. may use any
suitable tracking system/device to ensure effectiveness of change.
3.7.19 All
change controls should have the approval of the representative of the principal
company and the representative should sign off on the change control form.
4.0 FREQUENCY: As and when required.
5.0 RESPONSIBILITY: Change control Committee
& G.M-Q.A
6. 0 REVIEW GUIDE : Change Control Form.
7.0 ANNEXURE:
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8.0 SOPs
DISTRIBUTION:
This
SOP shall be distributed to following Departments:
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Name of the Department
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Master Copy
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Circulatory Copy
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QA/QC
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√
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√
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Production
|
x
|
x
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Warehouse
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x
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x
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General
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x
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x
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Maintenance
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x
|
x
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