Institute of Validation Technology

David M. Stephon
66
1. PURPOSE
1.1. This procedure provides instructions for the initiation and approval of system, process, materials,
product or procedure changes. The change control program provides for a classification scheme to
evaluate changes in controls, chemistry, components, manufacturing sites, scale of manufacturing,
manufacturing equipment, and production processes. The change control classification system will
determine what level of testing, validation, and documentation is required to justify changes to a
system, process, materials, product, or procedure.
2. SCOPE
2.1. This procedure applies to system, process, materials, product, or procedures associated with the
manufacture of clinical and commercial pharmaceutical drug products. All changes are approved
by the Quality Unit and approval by Regulatory Affairs prior to implementation.
Disclaimer: This change control system is not applicable when performing certain operations to
equipment or systems where routine servicing or preventative maintenance may be performed.
Examples may include, but are not limited to, changing resin beds or filters on a validated water
system, changing equipment components on a laboratory instrument. The routine servicing and
preventative maintenance must be based on exchange of like for like components. In all cases,
review must be provided of the proposed action to determine if the action represents an actual
change to the equipment or system, or in fact represents an action allowed by a current standard
operating procedure such as routine servicing or preventative maintenance.
3. RESPONSIBILITY
3.1. Change Initiator
3.2. Regulatory Documentation
3.3. Quality Unit
3.4. Regulatory Affairs
4. DEFINITIONS
4.1. Change any addition to, deletion of, or modification to a system, process, materials, product, or
procedure.
4.2. Change Initiator Quality Control, Chemical Development, Product Development, Engineering,
Manufacturing
4.3. Minor Change a change unlikely to have a detectable impact on the critical attributes of a system, pro-
cess, materials, product, or procedure. [For example: equivalent rewording of instructions or batch record
format changes] Minor changes require periodic regulatory agency (Food and Drug Administration
[FDA]) notification in the form of an annual report (Drug Master File [DMF], Investigational New Drug
Application [IND], New Drug Application [NDA], Abbreviated New Drug Application [ANDA]). [For
example: if it is determined that extensive editorial changes to a master manufacturing record dif-
fer substantially from the current process description filed with the regulatory agency (FDA).]
4.4. Moderate Change a change that could have a significant impact on the critical quality attributes
of a system, process, materials, product, or procedure. [For example: packaging design change,
order of addition of components, mixing parameters in a process.] Moderate change requires reg-
ulatory agency (FDA) notification in the form of an amendment to the current regulatory filing
(DMF, IND) or Change Being Effected (CBE), CBE/30 days supplement for approved drug applica-
tion (NDA/ANDA) dependent on an evaluation of the type of change.
Your Companys Name Effective Date:
Standard Operating Procedure July 2001
Document Number: Title: Page:
Change Control Management 1 of 7
Special Edition: Change Control
David M. Stephon
67
4.5. Major Change a change that would likely have a significant impact on the critical quality
attributes of a system, process, materials, product, or procedure. [For example: a change in major
equipment or change in manufacturing site.] Major change requires regulatory agency (FDA) notifi-
cation in the form of an amendment to the current regulatory filing (DMF, IND) or Prior Approval
Supplement (PAS) to an approved drug application (NDA/ANDA).
5. REFERENCE DOCUMENTS
5.1. Exhibit A: Change Control Part 1 Approval Form
5.2. Exhibit B: Change Control Evaluation Form
5.3. Exhibit C: Change Control Part 2 Implementation Form
6. SAFETY CONSIDERATION(S)
6.1. Not applicable.
7. PROCEDURE
7.1. A proposal for change to a system, process, materials, product, or procedure is initiated by cre-
ation of a Change Control Part 1 Approval Form (refer to Exhibit A). This document is completed
by the change initiator.
7.2. The change initiator completes Exhibit A by:
7.2.1. Stating the description of the proposed change
7.2.2. Providing the rationale for the proposed change
7.2.3. Attaching to the Change Control Part 1 Approval Form (Exhibit A) any drawings, litera-
ture, or memos/reports that aid in defining the proposed change
7.2.4. Forwards the Change Control Part 1 Approval Form to Quality Assurance (QA)
7.3. QA reviews the Change Control Part 1 - Approval Form and:
7.3.1. Requests from Regulatory Documentation a change control number
7.3.2. Determines the classification of the proposed change
7.3.3. Determines if any support work is required to evaluate the impact of the change
7.4. If applicable, the change initiator and the Quality Unit jointly complete any agreed upon action
required to support the proposed change.
7.5. The change initiator signs and dates the change control document, then forwards the Change Control
Part 1 Approval Form to the responsible manager of the area affected by the proposed change.
7.6. Responsible manager:
7.6.1. Verifies that the proposed change is acceptable
7.6.2. Signs and dates the prepared Change Control Part 1 - Approval Form
7.6.3. Forwards the Change Control Part 1 - Approval Form to the Quality Unit
7.7. Quality Unit:
7.7.1. Evaluates the proposed change for product/process impact
Your Companys Name Effective Date:
Standard Operating Procedure July 2001
Document Number: Title: Page:
Change Control Management 2 of 7
Institute of Validation Technology
David M. Stephon
68
7.7.2. Evaluates the agreed upon action to determine the impact of the change
7.7.3. If acceptable, approves the proposed change by signature and date
Note: As required, a change control meeting may be held between Quality Unit, change initia-
tor, responsible manager, and any affected departments to discuss the proposed changes.
Formal meeting minutes and conclusions are appended as supportive documentation to the
Change Control Part 1 Approval Form.
7.8. Quality Unit forwards original completed Change Control Part 1 - Approval Form (Exhibit A) to
Regulatory Documentation for filing.
7.9. Regulatory Documentation records and maintains the assigned change control number and pro-
vides a brief explanation of the change in the change control tracking system that includes record-
ing the current system, process, materials, product, or procedure affected by the change (e.g.,
master manufacturing record, analytical monograph, etc.). Any new assigned document numbers
for system, process, materials, product, or procedures impacted by the change are also recorded
in the tracking system.
7.10. Quality Unit notifies Regulatory Affairs of the approved changes by forwarding a copy of the
approved Change Control Part 1 - Approval Form and requests approval for implementation of the
approved changes.
7.11. Regulatory Affairs:
7.11.1. Conducts an evaluation of the change and determines the impact and required notification to
the regulatory agency (FDA)
7.11.2. Based on this assessment, indicates whether or not Quality Unit approved change requires
regulatory agencys (FDA) prior approval or can be implemented without regulatory agencys
(FDA) prior approval
7.11.3. Contacts Regulatory Documentation for assignment of Change Control Evaluation (CCE)
number
7.11.4. Approves Exhibit B and provides original to Regulatory Documentation and copy to change
initiator and responsible manager
7.12. Change initiator and responsible manager who requested the change to system, process, materials,
product, or procedure implements the change in accordance with the change outlined on the Quality
Units approved change control form and within any restrictions (e.g., when change can be implement-
ed) or requirements (e.g., request for additional documentation required for regulatory filing update)
imposed by Regulatory Affairs assessment as outlined on the corresponding approved CCE form.
7.13. The Quality Units approved and Regulatory Affairs evaluated change is implemented by the des-
ignated change implementer followed by completion of Action Taken in Exhibit C, Change Control
Part 2 Implementation Form.
7.14. Exhibit C is then forwarded to the Quality Unit for review and approval.
7.15. Quality Unit reviews the Action Taken section in Exhibit C and compares it to the Agreed Upon
Action in Exhibit A, and determines if the change made agrees with the approved change, and
that any change evaluation requirements (revalidation, stability, etc.) have been initiated or com-
pleted.
7.16. Regulatory Documentation updates the change control tracking system to record any require-
ments listed on the approved CCE and Change Control Part 2 Implementation Form.
Your Companys Name Effective Date:
Standard Operating Procedure July 2001
Document Number: Title: Page:
Change Control Management 3 of 7
Special Edition: Change Control
David M. Stephon
69
8. RECORDS
8.1. Exhibit A: Change Control Part 1 Approval Form. Change control form numbers are assigned by
Regulatory Documentation. The forms are numbered sequentially as CC-# beginning with CC-1
and continuing indefinitely.
8.2. Exhibit B: Change Control Evaluation Form. CCE form numbers are assigned by Regulatory
Documentation. The forms are numbered sequentially as CCE-# beginning with CCE-1 and contin-
uing indefinitely.
8.3. Exhibit C: Change Control Part 2 Implementation Form. Change control implementation forms
are numbered to match the corresponding Change Control Part 1 - Approval Form to which it
refers (i.e., CC-#).
8.4. Change Control Tracking System.
9. RECORD DISTRIBUTION
9.1. Change Control Part 1 Approval Form: original to be maintained by Regulatory Documentation;
copy provided to change initiator and responsible manager.
9.2. Change Control Evaluation Form: original to be maintained by Regulatory Documentation.
9.3. Change Control Part 2 Implementation Form: original to be maintained by Regulatory
Documentation.
9.4. Change Control Tracking System: maintained by Regulatory Documentation.
10. REVISION LOG
Revision Date Section(s) Description
00 N/A Original Issue
11. APPROVALS
Written By: _______________________________________ Date:_____________________________
Reviewed By: ______________________________________ Date:_____________________________
Approved By: ______________________________________ Date:_____________________________
Quality Unit
Your Companys Name Effective Date:
Standard Operating Procedure July 2001
Document Number: Title: Page:
Change Control Management 4 of 7
Institute of Validation Technology
David M. Stephon
70
Exhibit A: Change Control Part 1 Approval Form
Your Company Name Change Control Part 1 Approval Form
Change Control Number: CC-
Change Initiator Name:
Change Initiator Department:
Description of Proposed Change: [Completed by Initiator]
Rationale for Proposed Change: [Completed by Initiator]
Classification of Change:[Completed by Quality Unit]
Minor Moderate Major
Is further work required to evaluate the impact of the change on the product? Yes No
(If YES, define the scope of the work to be completed in the next section, Agreed Upon Action)
Agreed Upon Action: [Completed by Initiator and Quality Unit]
(Include supportive studies [e.g., required pre- and post change equivalency testing or revalidation studies,
as appropriate.])
Approvals:
Proposed Change Submitted By:
Initiator, Title: ____________________________________ Date:_____________________________
Proposed Change Approved By:
Initiator, Title: ____________________________________ Date:_____________________________
Change Approved By:
Quality Unit:_____________________________________ Date:_____________________________
Your Companys Name Effective Date:
Standard Operating Procedure July 2001
Document Number: Title: Page:
Change Control Management 5 of 7
Special Edition: Change Control
David M. Stephon
71
Exhibit B: Change Control Evaluation Form
Your Company Name Change Control Evaluation Report No.: CCE-
Change Control Number: Attach Copy of Approved Change Control Form
Impact of Change Evaluation: [List reference to current regulatory filing if applicable.]
Select Regulatory Filing Change Requirement to Support Change:
No regulatory filings are in place at this time
No change to RCD* required
Change to RCD* is required (If this box is selected, choose one of the options below)
Annual Report Amendment CBE PAS
Comments:
* RCD = Regulatory Commitment Document
Signature below indicates that the change approved by the Quality Unit can be implemented at a date equal to
or greater than the regulatory approval date stated below.
Regulatory Affairs:________________________________ Date:_____________________________
Maintain original copy of approved change control evaluation in Regulatory Documentation file.
Your Companys Name Effective Date:
Standard Operating Procedure July 2001
Document Number: Title: Page:
Change Control Management 6 of 7
Institute of Validation Technology
David M. Stephon
72
Exhibit C: Change Control Part 2 Implementation Form
Your Company Name Change Control Part 2 Implementation Form
Request from Regulatory Documentation at time change will be implemented.
Change Control Number: CC- (Same number as Change Control Part 1 Approval Form)
Action Taken: [Completed by Change Implementer]
Completed By:
Name, Title: _____________________________________ Date:_____________________________
Quality Unit Follow-Up:
Quality Unit:_____________________________________ Date:_____________________________
Maintain original copy of approved change control form in Regulatory Documentation file.
Your Companys Name Effective Date:
Standard Operating Procedure July 2001
Document Number: Title: Page:
Change Control Management 7 of 7
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