Provide Instruction For Change Control Procedure
1.0 OBJECTIVE:
To
lay down the documented procedure for change control procedure.
2.0 SCOPE:
This
SOP shall be applicable for change
control procedure.
3.0 RESPONSIBILITY:
3.1
Officer/ Supervisor
of respective department.
4.0 ACCOUNTABILITY:
4.1
Overall:
Respective Department Head.
5.0 PROCEDURE:
5.1 Components of
change control:
5.1.1
Following changes
are including in-charge control procedure.
5.1.1.1 Change
in the storage condition of raw material, finished goods, WIP.
5.1.1.2 Change
in expiry or retest date.
5.1.1.3 Change
in stability study protocol.
5.1.1.4 Change
in SOP.
5.1.1.5 Change
in protocol.
5.1.1.6 Change
in batch manufacturing record.
5.1.1.7 Change
in batch packing record.
5.1.2
Change in
specification and analytical test method of following:
5.1.2.1 Raw
materials and packaging materials.
5.1.2.2 In-process
and intermediates.
5.1.2.3 Finished
products.
5.1.2.4 Change
in drawings.
5.1.2.5 Change
in utilities.
5.1.2.6 Change
in manufacturing process including rework and re-processing.
5.1.2.7 In-process
controls.
5.2 Change control
procedure:
5.2.1
Any of the change
excluding the changes in specifications, analytical methods, master formula,
match manufacturing records and those changes affecting the regulatory affairs
shall be controlled by the corporate Q.A.
5.2.2
Any changes at
related to GMP requirements but not directly related to manufacturing or
testing process shall be controlled through Q.A.
5.2.3
The person
requesting the change should fill in the ‘Change Control Form’ and submit it to
Q.A In-charge through the department head.
5.2.4
The person
requesting the changes shall add any reasons or justification with adequate
supporting data for the change to the ‘Change Control Form’.
5.2.5
The Q.A In-charge
shall evaluate the change proposal considering the necessity for change and any
other GMP aspects that will be affected by the proposed change. If the Q.A
In-charge has the valid reasons to reject the proposal for change, he/ she can
reject the change proposal and intimate the requester about the same.
5.2.6
The Q.A In-charge
shall verify the proposed change by a number of factors.
5.2.7
If required the
Q.A In-charge shall direct the changes to corporate Q.A.
5.2.8
If the supporting
data is not sufficient, he/ she shall direct the requester or any other related
departments e.g. Quality Control to generate the specified information or data.
5.2.9
The Q.A In-charge
shall approve the change and shall forward the request to corporate Q.A for
their evaluation & suggestions if required.
5.2.10 If
proposed change is in the preview of corporate Q.A, the Q.A In-charge shall
forward the change control form with his/ her remark or suggestions to the
corporate Q.A. Q.A personnel shall coordinate with corporate Q.A for the
proposed change.
5.2.11 Once
the Q.A department approves the change control form, the user department shall
prepare relevant revised documents.
5.2.12 The
revised document shall be approved by Q.A In-charge.
5.2.13 User
department shall implement the change, based on effective date mentioned on the
documents.
5.3 Note:
5.3.1
For any proposed change
it is necessary to confirm that, the proposed change will not violet the
statutory requirements. If it is require informing to statutory authority of
the concern country or to the concern buyer, it is necessary to first get
approval from statutory authority of the concern country or from the buyer,
than only proposed change shall be implemented.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
Annexure 1: Log
Book for Change Control.
Log
Book for Change Control
|
Change Control Form
|
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
SOP |
Standard operating
procedure |
|
& |
And |
|
No. |
Number |
|
Ltd. |
Limited |
|
QA |
Quality assurance |
|
F |
Format |
|
GMP |
Good manufacturing
practice |
|
WIP |
Work in process |