1.0 Purpose
1.1 To describe the various steps that are required to be followed in implementing any change that may affect product quality.
2.0
Scope
2.1
This Sop is Applicable for all changes e.g.,
starting materials, process equipment, process environment, Product component,
service, utilities, facilities, drawing, document, methods of analysis,
Specification or any other change made in NAME Pharmaceutical Ltd. that may
affect product quality.
3.0
Responsibility
3.1
Initiator – the Initiator is
responsible for raising the Change Control.
3.2
Head of Department is
responsible for assessing the proposed change where the Change is to take place
and approve the impacts and risk of the Change.
3.3
Regulatory Affairs-
Responsible for communicating and obtaining client or Regulatory approvals
3.4
Quality Assurance- Responsible
for assessing the proposed change and its impact, overall
Compliance with the change
control process and final approval.
4.0 Abbreviations and Definitions
4.1 Change: Any addition to deletion of or modification to a system, process, materials, product, procedure or equipment.
4.2 Change Control: A system of procedures through which changes are reviewed, justified, documented, approved and implemented in conformance with regulatory requirements.
4.3 Major Change: A Change that has substantial potential to have adverse effect on the identity, strength, quality, purity or potency of a drug product.
4.4 Moderate Change: A change that has moderate potential to have adverse effect on the identity, strength, quality, purity or potency of a drug product.
4.5 Minor Change: Change having no direct impact on final or in-process product quality.
4.6 The list below gives examples of change that shall be followed if any of the following changes are required.
4.6.1 Product and Component/composition
4.6.1.1 Major Change – Any qualitative and quantitative Change in formulation including Inactive Ingredients
4.6.1.2 Minor Change – Deletion or reduction of an Ingredient intended to affect only the color of the Product
4.6.1.3 Major Change – Change in Expiry Date or Storage condition
4.6.2 Manufacturing Sites
4.6.2.1 Major Change – Moving to a different Manufacturing Site
4.6.2.2 Minor Change - Moving to different site for Secondary Packaging only
4.6.3 Manufacturing Process
4.6.3.1 Major Change – Any fundamental change in the Manufacturing Process/Equipment such as wet to dry Granulation.
4.6.4 Specification / Method
4.6.4.1 Major Change – Deleting/Changing any part Regulatory specification
4.6.4.2 Major Change – Establishing/Changing new Analytical Testing Method
4.6.4.3 Minor change – Tightening of the release specification of the final product
4.6.4.4 Major Change - Change in cleaning Method/Frequency
4.6.5 Materials
4.6.5.1 Major Change – Change in the Supplier or manufacturing source of any Active Ingredient or Primary Packaging Material.
4.6.6 Packaging
4.6.6.1 Major change – Any change in Primary Packaging components
4.6.7 Equipment
4.6.7.1 Major Change – New Equipment or Utilities
4.6.7.2 Major Change – Relocation
4.6.7.3 Major Change – Modification affecting the mode of operation
4.6.7.4 Major Change – Change of Control Parameter4.6.7.5 Major Change – Replacement of non-like for like parts during repairs or maintenance
4.6.8 Facilities
4.6.8.1 Major
Change – Change to Classification of an Area
4.6.8.2 Major
Change – Change to Layout, Design
4.6.8.3 Major Change – New Facility
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 None
7.0 Procedure
7.1 The Change mechanism shall be formally processed through a Change Control form, show in the attachment. (Annexure-I)
7.2 Change Control proposal shall be raised/initiated by a person of the relevant Department and checked by Department Head.
7.2.1 Initiate the Change Control and enter full details of the proposed change in section A.
7.2.2 Complete Section A of the Change Control providing as much detail as possible to aid the review and assessment of impacts of the change.
7.3 Review the proposed Change and take due consideration of the impact that will affect the change. Give full consideration to both direct and indirect impacts of the change.
7.3.1 Ensure that sufficient supporting data has been submitted in order that the impacts of the Change Can be adequately assessed.
7.3.2 Complete a preliminary risk assessment of the Change and document it on the Change Control form.
7.4 Make an assessment as to what other peripheral documents or systems may be affected by Change and require either update or implementation.
7.4.1 Write all affected documents which require Change by the concerned Department/Area and put Sign and date.
7.5 Then the initiator shall forward it to QA Department with necessary details.
7.6
QA shall allot a change number for example, a
CC
Example – CC/001/06/22, where ‘CC’ for Change control, ‘001’ sequential number,’06’ for month ‘June’ and ‘24’ for the year ‘2024’
7.6.1 Enter the Change number in Change Control Log Book. (Annexure-II)
7.6.2 QA shall determine whether the Change is major, moderate or minor.
7.7 If any Change is requested by Regulatory, Authority, Quality Assurance shall initiate Change Control.
7.7.1 Communicate with the regulatory authorities and take approval of the Change proposed from the regulatory Client before the change takes place.
7.8 If applicable, the Change Control form shall be forwarded to Head of Production, Quality Control, Product Development, Regulatory Affairs, Marketing and Engineering for his/their Comments/agreement on the proposed change.
7.9 Review and understand the proposal, its associated risks and impacts.
7.10 Assess the need of Validation. If Validation is required and the change is approved then raise a Validation number.
7.11 Depending upon the outcome of the review the form will then be routed as follows:
7.11.1 If the change is approved and Regulatory/Client approval is required then notify the Regulatory Affairs to begin the approval process. Inform the decision to the Initiator and Head of Department.
7.11.2 If the change is approved and does not require Regulatory approval or is conditionally approved then send It to Head of Quality Assurance for final review and approval.
7.11.3 If the change is not approved, archive the record and inform the decision to the Initiator and the Head of Department.
7.12 Before approval, Head of Quality Assurance will review all sections of the Change Control form to ensure that
7.13 After approval send the approval form to the Initiating Department for implementation.
7.14 Upon receiving an approved Change Control form, implement the approved change in accordance with any conditions or limitations denoted on the form.
7.14.1 Implement the change must be as per the proposed method. Any deviation form this method a additional Changes required must be approved prior to the change takes place.
7.14.2 Once the change is complete add the date of implementation.
7.14.3 Head of Department will review the outcome of the Change and confirm that the expected impacts were as expected.
7.15 The Initiating Department shall be update relevant documents and shall inform the implementation of Change to quality Assurance Department and send the form to Quality Assurance.
7.16 Quality Assurance will perform an overall review of the completed form, it’s approvals and outcomes.
7.17 Archive all approved and completed Change Control documents in the Change Control File in Quality Assurance department.
7.18 Archive all unapproved change control form in the Change Control File in Quality Assurance Department.
7.19 Review the Change Control File quarterly in order to identify incomplete Change Control forms.
8.0 Reference Document
8.1 WHO GMP Guideline; TRS-986, Annex-2 ;
8.2 In house
9.0 Annexure
9.1 Annexure-I : “Change Control Form.
9.2 Annexure-II : Change Control Log Book
10.0
Revision
History
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Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
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New |
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11.1 Head of Quality Assurance or his nominee give the training of all Officer and Manager of all Department.
Annexure-I
CHANGE CONTROL FORM
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Section- A: Details of Change (To be
completed by Initiator / Originator) |
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Date: |
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Name
of the Department(s) affected by Change |
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Type of Change ( Ö
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Š Formulation Š Process Š Specification Š Analytical Method Š Supplier Š Facility / Utilities Š Manufacturing Site Š In-process Control Š Packing Š Batch Size Š Environment Conditions Š Expiry Date Š Others |
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Name of the Product / Utility / Equipment Involved |
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List of Processes /Product affected by the change |
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Brief Description of current status |
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Details of Proposed Change |
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Justification for the proposed Change |
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Initiated by Sign & Date |
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Checked by Sign & Date |
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Name |
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Name |
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Designation |
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Designation |
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Section-B: Impact and Risk Assessment
(To be completed by the Department Head) |
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Preliminary
Assessment of Risk and related impacts |
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Signature & Date |
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Name |
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Designation |
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Documents
affected by the change |
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Sl. No. |
Document Title |
Document No. |
Document Changed (Y /
N) |
Sign. |
Date |
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Section-C : Evaluation of Change
Proposal |
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QUALITY
ASSURANCE DEPARTMENT |
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Change
Number |
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Date |
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Allotted
by (Sign. / Name) |
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Change Category |
Major Š Moderate Š Minor Š |
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Assessment for approval: Š Change Proposal Accepted Š
Change Proposal Refused |
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Production
(If applicable) |
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Comments |
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Sign. & Date |
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Designation |
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Quality
Control (If applicable) |
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Comments |
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Sign. & Date |
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Product
Development (If applicable) |
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Comments |
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Sign. & Date |
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Designation |
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Regulatory
Affairs (If applicable) |
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Comments |
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Sign. & Date |
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Designation |
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Section-C : Evaluation of Change
Proposal |
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Marketing (If applicable) |
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Comments |
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Sign.
& Date |
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Designation |
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Engineering (If
applicable) |
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Comments |
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Sign.
& Date |
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Designation |
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Risk Assessment and associated impacts
(To be completed by Quality Assurance) |
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Comments |
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Sign.
& Date |
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Name |
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Designation |
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Assessment of
validity (To be completed by Quality Assurance) |
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The
Propose change may- |
( Ö ) |
Sign |
Date |
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Be implemented
immediately |
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Not to be implemented
until |
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Be implemented
subject to the condition below |
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Not to be implemented
for the reason below |
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Is qualification? (if
“Yes” insert validation Number) |
Validation Number : |
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The Proposed Change
may be implemented as described above |
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Approved by / Date |
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Name |
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Designation |
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Section-D :
Close of Change Control |
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The
proposed change was completed and impacts were as expected. All associated
actions related to the change have been completed |
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Date
change implemented |
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Name |
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Sign. |
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Initiator |
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Head of Department |
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Quality
Assurance |
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Annexure-II
CHANGE CONTROL LOG BOOK
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Sl.
No. |
Initiate
Date |
Change
Control No |
Product
Name / Description |
Sign
& Date (QAD) |
Remarks |
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