David David M. Stephon Stephon
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Standard Operating Procedure
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Change Control Management
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1. PURPOS POSE 1.1.
This procedure procedure provides provides instructions instructions for the initiation initiation and and approv approval al of system, system, process, process, materials, materials, product or procedure changes. The change control program provides for for a classification scheme to evaluate changes in controls, chemistry, chemistry, components, manufacturing sites, scale of manufacturing, manufacturing equipment, and production processes. 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 procedure applies to system system,, process process,, materials materials,, product, product, or proced procedures ures associated 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 performing certain operations to equipment or systems where routine servicing or preventative 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 components on a laboratory instrument. The routine servicing and preventative preventative maintenance must be based on exchange of like for 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. RESP RESPONS ONSIBI IBILIT LITY Y 3.1.
Change In Initiator
3.2. 3.2.
Regul egulat ator ory y Docum ocumen enta tattion ion
3.3.
Quality Unit
3.4.
Regulatory Affairs
4. DEFINITI DEFINITIONS ONS
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4.1.
Change Change – any any additio addition n to, to, deletion deletion of, or modifica modification tion to a system, system, process process,, materials materials,, product, product, or procedure.
4.2.
Change Change Initiat Initiator or – Quality Quality Control, Control, Chemical Chemical Developme Development, nt, Product Product Dev Developm elopment, ent, Engineering, Engineering, Manufacturing
4.3.
Minor Change Change – a change change unlike unlikely ly to have have a detect detectable able impact impact on the critical critical attribut attributes es of a system, system, process, materials, product, or procedure. procedure. [For example: example: equivalent rewording rewording of instructions or batch record format changes] Minor changes require periodic regulatory agency (Food and Drug Administration [FDA]) [FDA]) notification in the form of an annual report (Drug Master File [DMF], Investigational New Drug Application [IND], New Drug Application [NDA], Abbreviated Abbreviated New Drug Application [ANDA]). [For example: if it is determined that extensive editorial changes to a master manufacturing manufacturing record differ substantially from the current process description filed with the regulatory agency (FDA).]
4.4.. 4.4
Modera Mod erate te Chang Change e – a change change that coul could d have have a signific significant ant im impac pactt on the criti critical cal quali quality ty attrib attribute utes s of a system, process, materials, product, or procedure. [For example: example: packaging design change, change, order of addition of components, mixing parameters in a process.] Moderate change requires regulatory agency (FDA) notification in the form of an amendment to the current regulatory filing (DMF, (DMF, IND) or Change Being Effected (CBE), CBE/30 days supplement for approved drug application (NDA/ANDA) (NDA/ANDA) dependent on an evaluation of the type of change.
Institute of Validation Technology
David M. Stephon
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4.5.
Effective Date:
Standard Operating Procedure
July 2001
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Change Control Management
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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) notification 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 creation 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:
7.3.
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, literature, 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)
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:
7.7.
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
Quality Unit: 7.7.1.
Evaluates the proposed change for product/process impact
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David M. Stephon
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Standard Operating Procedure
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Change Control Management
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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 provides a brief explanation of the change in the change control tracking system that includes recording 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 agency’s (FDA) prior approval or can be implemented without regulatory agency’s (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
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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 Unit’s approved change control form and within any restrictions (e.g., when change can be implemented) 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 Unit’s approved and Regulatory Affairs’ evaluated change is implemented by the designated 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 completed.
7.16.
Regulatory Documentation updates the change control tracking system to record any requirements listed on the approved CCE and Change Control Part 2 – Implementation Form.
Institute of Validation Technology
David M. Stephon
Your Company’s Name
Document Number:
Effective Date:
Standard Operating Procedure
July 2001
Title:
Page:
Change Control Management
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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 continuing 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
00
Section(s)
Description
N/A
Original Issue
11.APPROVALS
Written By: _______________________________________ Date:_____________________________
Reviewed By: ______________________________________ Date:_____________________________
Approved By: ______________________________________ Date:_____________________________ Quality Unit
Special Edition: Change Control
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David M. Stephon
Your Company’s Name
Effective Date:
Document Number:
Standard Operating Procedure
July 2001
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Page:
Change Control Management
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Exhibit A: Change Control Part 1 – Approval Form
Your Company Name
Change Control Number:
Change Control – Part 1 Approval Form
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:_____________________________
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Institute of Validation Technology
David M. Stephon
Your Company’s Name
Document Number:
Effective Date:
Standard Operating Procedure
July 2001
Title:
Page:
Change Control Management
6 of 7
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.
Special Edition: Change Control
71
David M. Stephon
Your Company’s Name
Document Number:
Effective Date:
Standard Operating Procedure
July 2001
Title:
Page:
Change Control Management
7 of 7
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-
Action Taken:
(Same number as Change Control Part 1 – Approval Form) [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.
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Institute of Validation Technology
