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| Change Control |
Logo COMPANY NAME
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STANDARD OPERATING PROCEDURE |
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Doc No.
: ABC/ QA / SOP / 00X |
Department: Quality Assurance |
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Revision No: X |
Prepared on: xx/yy/zzzz |
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Distributed To: All department |
Effective Date : |
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TITLE : CHANGE CONTROL MANAGEMENT |
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1.0
OBJECTIVE
1.1 To provide the procedure to evaluate all changes affecting the production and control of products and cGMP-relevant systems.
1.2 To ensure representatives of appropriate disciplines review proposed changes that might affect the validated status of facilities, systems, equipment, processes, and documentation and to determine the need for actions that would ensure documentation and system are maintained in a validated state and do not affect product quality, safety, Purity, efficacy and stability.
2.0 SCOPE
2.1 This procedure covers the initiation, logging, classifications, review, impact assessment, approval and closing of all cGMP-relevant changes that may affect the manufacturing and control of In-process and finished products of ABC Pvt Ltd, City.
2.2 Introduction of service, process, product, system, and utilities which are expected to have an impact on the current and or corresponding existing systems shall be routed through change control.
3.0
RESPONSIBILITY
3.1 It is the responsibility of the owner of the process, procedure, system, facility, Utility etc., for initiation of the change.
3.2 It is the responsibility of other relevant department personnel to give their comments on the change identify affecting documents in their department and take required actions and follow-up.
3.3 It is the responsibility of RA & marketing to assess the impact of the change on regulatory filing, commitments and notification requirements and act accordingly.
3.4 It is the responsibility of designees in QA to log, evaluate and assess the change impact on the product, System, facility, and Utilities follow-up on recommended actions, approve or reject and closing of the change control.
4.0
ABBREVIATIONS/ DEFINITIONS
Abbreviations
1.1.1
SOP : Standard
Operating Procedure
1.1.2
HOD : Head of the Department
1.1.3
RA : Regulatory
Affairs
1.1.4
cGMP : Current Good
Manufacturing Practice
1.1.5
HVAC : Heating
Ventilation and Air Condition
1.1.6
QA : Quality
Assurance
1.1.7
Ex : Example
1.1.8
RH : Relative
Humidity
1.1.9
IT :
Information Technology
1.1.10
EH&S : Environmental,
Health & Safety
1.1.11
MK : Marketing Department.
1.1.12
PR : Purchase Department.
1.1.13
API : Active
Pharmaceutical Ingredient.
1.1.14
QC : Quality
Control.
1.1.15
FD :
Formulation research and development
1.1.16
TTD : Technology
Transfer Department
1.1.17
AD : Analytical Development
1.1.18
PD : Production
1.1.19
QP : Qualified
person
1.1.20
PKD : Packaging
development
1.1.21
SISPQ : Safety, Identity, Strength, Purity and
Quality
1.1.22
SEZ : Special
Economic Zone
1.1.23
ICH : International
Council for Harmonization of Technical Requirements for Pharma for
Human Use
1.1.24
EU-GMP : European Union Good Manufacturing Practices
1.1.25
TSE : Transmissible Spongiform Encephalopathy
1.1.26
BSE : Bovine Spongiform Encephalopathy
1.1.27
MPC : Master Packaging Card
1.1.28
MFC : Master Formula Card
1.1.29
TA : Technical
Agreement
1.1.30
BMR : Batch Manufacturing Record
1.1.31
BPR : Batch Packaging Record
1.1.32
VMP : Validation Master Plan
1.1.33
MSDS : Material Safety Data Sheet
1.1 Definitions:
1.1.1 Change control - Definition
A structured approach where qualified representatives from relevant fields evaluate proposed or existing alterations that could impact the validated status of facilities, systems, equipment, or processes. The goal is to assess whether actions are necessary to maintain and formally document the system's validated state.
1.1.2 Change: Any planned introduction of product, equipment, facilities or utilities, any addition to, deletion of, or modification to process/procedures, materials, product or practices, or new introduction to facility or premises.
1.0
PROCEDURE
Note: All proposed changes shall be routed
through the Management of the change control system.
1.1 Changes made to the following reasons but not limited to
1.1.1
Regulatory requirements
1.1.2
Improvements to the good manufacturing practices
1.1.3
Improvement to quality attributes of
finished products.
1.1.4
Capacity enhancement
1.1.5
Introduction of new finished products.
1.1.6
Cost reduction
1.1.7
Automation
1.1.8
Aging of facility
1.1.9 Customer and Marketing Requirements
1.1.10
Handle the unavoidable situation
1.2
Changes are associated with the following but not limited to:
1.2.1
Changes in the document (SOP / Site Master File / Validation
Master Plan etc.)
1.2.2
Changes in the Facility
1.2.3
Changes to equipment/instruments
1.2.4
Changes in raw materials and or manufacturing process
1.2.5
Changes in Specifications
1.2.6
Changes in test methods
1.2.7
Changes to Utilities
1.2.8
Changes in software and hardware
1.2.9
Relocation of equipments
1.2.10
Modification of existing equipment
1.2.11 Changes to label
1.2.12
Changes to Packaging Materials.
1.2.13 Changes to manufacturing site
1.2.14 Changes in vendor (APIs, Excipients and Primary, and secondary packing material)
1.2.15 Changes in approved artworks and Changes in design space etc
1.3 CLASSIFICATION OF CHANGES
Changes are categorized into MAJOR and MINOR depending on their impact on the process and product quality.
1.3.1
MAJOR CHANGE:
Ø Expected to have a potential effect on the quality attributes (SISPQ) of Finished Product such as dissolution, Assay, purity, stability, disintegration time, particle size bioequivalency impurity profile, microbial attributes etc.
Ø Warrants suitable revalidation, stability
studies and or equivalency to justify the change.
Ø Require customer and regulatory
notification.
1.3.2
MINOR CHANGE:
Ø Is unlikely to have a detectable impact on the quality attributes (SISPQ) of the finished product such as dissolution, Assay, purity, stability, disintegration time, particle size, bio-equivalency impurity profile, microbial attributes etc.
Ø Does not require extensive
validation.
Ø Require customer
notification if it is part of the quality agreement.
Ø Require regulatory notification.
1.3.3
Changes in further
circumstances:
Ø Other changes apart from above examples cited above shall also be classified as major or minor based on the effect of change on product SISPQ.
Ø Management of change procedure is not applicable for the replacement of spares (temperature indicators, scanners), gauges (pressure, vacuum gauges), and other equipment ancillaries’ replacement with the same design (Ex: Miller dome, sifter lid, transfer lines) which are routed through work order for execution, line clearance and subjected for independent calibration as applicable.
Ø This management of change does not apply to some maintenance, or civil activities which are not connected to the product, or equipment line and which do not have direct or indirect impact on product
quality. (Ex: Construction of roof at water generation plant, construction wall
for segregation, raising wall height, change in direction of utilities lines)
which are routed through work orders for execution and line clearance.
1.4 INITIATION OF MANAGEMENT OF CHANGE (Section-I-Proposal for change)
1.4.1 The originator shall obtain “Management of Change” ( Annexure-I) from QA.
1.4.2 The originating department should write all the details including proposed change(s), Existing status and reason for the change in the “Management of Change Form (Annexure-I)” and forward it to QA.
1.4.3 Supporting documents for the proposed change shall be attached to the form by the originator. Shall assign a number as below and log it in the “Management of Change Log”.
Structure of Number: ABC/CCF/DDD/YY/NNN, Where
ABC indicates the Name of the company
CCF indicates Change Control Form
and in general, is given as GEN.
YY indicates the last two digits of the calendar year
in which change is requested
It indicates the serial number of the change.
Example: a) AMP/CCF/GEN/DDD/YY/NNN
1St Management of change which is related
to general at ABC in the year 20.
1St Management of change which is related to general at ABC in the year 20.
b) ABC/CCF/AH/18/00
1St Management of change which is related to Amine HCl at ABC in the year 2018
Note: Any change that is not product specific such as facility modification, utilities, and common systems for all products etc. should be substituted by code “GEN” in place of product code
1.1.2 Section-II (Assessment of the impact of change) After assigning the number, QA shall review as per the “Management of Change assessment form (Annexure-I)” and assessment done by a cross-functional team for any additional information then call the associated department’s personnel (HOD or his designee) including with RA/Marketing/Purchase by teleconference for the actions to be taken relevant to the change.
1.1.3 Section-Ill: (Approval of Proposed change) Based on the discussions, conclusions shall be documented by QA in the “Management of Change Assessment form (Annexur-I)” for approval or rejection of change execution.
1.1.4 Acceptance for approval/rejection shall be taken from available participants. Electronic acceptance (email) shall be filed with CCF from personnel who participated in the telephonic/video conference.
1.1.5 Based on the conclusion, pre-execution, execution and post-execution requirements shall be documented in the “Management of Change Assessment form (Annexure-I)” by referring to the format “Management of change activities to be performed (Annexure-IV)” as a guidelines copy for assessment and mention relevant document number as applicable.
1.1.6 Based on the change assessment, risk analysis requirements shall also be considered
1.1.7 QA shall send a copy of the “Management of Change form” to the user department and other related departments as a reference copy to use as a guide during the execution phase.
1.1.8 The list of activities to be performed should be taken from the format Annexure-IV, other than the activities present in Annexure-IV shall be considered based on the proposed change and based on the recommendation of other department heads as per the assessment of the proposed change.
1.1.9 In case of changes in the facility, copies of finalized drawings shall be displayed at the respective place.
1.1 The Originator shall implement the changes as proposed and shall coordinate with the relevant department’s personnel for the completion of all the relevant activities, mentioned in the “Management of Change form (Annexure-I)” along with the thee activity sheet.
1.1.11 In
case of any scope expansion concerning proposed change it shall be routed
through “Management of Change - Scope Expansion / Change Form
(Annexure-II)” as
per the below procedure:
Ø Originator shall raise the “Management of Change - Scope Expansion / Change Form (Annexure-II)” to QA mentioned with the expansion of the scope.
Ø QA personnel shall call relevant department personnel for “Minutes of Meeting” about the expansion of the scope.
Ø Based on the “Management of Change Assessment Form”, QA shall write relevant actions to be taken concerning expanded scope in “Management of Change - Scope Expansion / Change Form ( Annexure-II)”. Relevant department personnel shall give their opinions, comments & approval on recommended actions concerning increasing scope.
Ø Based on the comments & approvals of the relevant department’s personnel, QA shall approve/reject the expansion of the scope.
Ø After approval by QA, the proposed scope expansion shall be implemented and “Management of Change - Scope Expansion / Change Form (Annexure-II)” shall be attached with the respective “Management of Change Form” along with the activity sheet.
1.1.12 Section-IV:(Implementation
of change)
After the
completion of the proposed change & all relevant activities which ever
mentioned in the “Management of Change form ( Annexure-I )” and “Management of
Change - Scope Expansion / Change Form (Annexure-II)”.
The originator shall submit
the relevant revised documents to QA as per the assessment.
1.1.13 QA shall review & approve the modified procedure/documents according to the actions mentioned in the Assessment Form, “Management of Change - Scope Expansion / Change Form (Annexure-II)”.
If applicable in case of any abnormalities found during review QA shall inform the tooriginator to get an accurate conclusion.
1.1.14 The personnel who were involved in all the relevant activities concerning proposed changes shall be trained by their superiors on documents/processes.
1.1.15 If
change requires prior approval from regulatory bodies or customers or QP the
same shall be implemented after obtaining the approval. QA shall further review
documentation of change and actions taken for change execution based on feedback
from regulations or customers.
1.1.16 Major changes should be notified to the customers. Change notification to the customers/ regulatory authorities shall be fulfilled through the format “Management of change- Customer / Regulatory Notification Form (Annexure-V)”
1.1.17 If change requires regulatory or customer notifications, the same will be done by the RA/Marketing Department. Change notification form shall be sent to RA/Marketing by QA.
Note: Irrespective of internal change
classification, if any change requires customer/ regulatory notification as per
RA assessment by respective country regulations, the same shall
be fulfilled.
As per internal classification, if any change does not call for notification to customer/ regulatory authority as per specific country regulations or customer quality agreement, the same shall be justified in change control.
1.1.18 QA shall also ensure that all controlled Copies of earlier versions are destroyed and the Master document is stamped with “OBSOLETE” and filed with QA archival.
1.1.19 QA depa The responsible for reviewing the change in terms of equivalency study, validation stability etc as applicable.
1.1.20 Section -V (Post Implementation review and Closure of change control form): Based on the outcome of the change review QA shall conclude the change control as approved or rejected and close the same through “Management of Change Form ( Annexure-I)” and Management of changelog by mentioning whether the change is approved or rejected, closing date, remarks (if any) and sign it.
1.1.21 If the change is rejected, appropriate actions shall be considered either going with the existing one / further optimization
1.1.22 Proposed changes should be implemented and respective management of change shall be closed within 45 working days for general change controls and product or facility/Utility related change controls shall be closed within 6 months from the date of initiation.
1.1.23 For site variations and after manufacturing two batches of new products or validation batches aa and third batches are not planned within the closure period change control can be closed by mentioning the proper reason.
1.1.24 Periodic review of change controls will be done by trained personnel and follow-up action is required for closure. Change controls will be reviewed the first week of every month for the status of change controls which are in the open stage and post-implementation requirements, for closed change controls and the status will be updated in the format Review and updation status of change control(Annexure-VII).
1.1.25 Any delay for the closure of the change control within the timelines will be justified as per the Format Annexure-VI.
1.2 Trending of
Change Controls:
1.2.1 Trends for the General and Product specific change controls should be prepared by including the number of changes initiated during the period and the reason for change along with the summary and conclusion on the changes.
2.0 ANNEXURES
2.2 Annexure-II: Management of Change - scope expansion/change form
2.3 Annexure-III :Management of Change log
2.4 Annexure-IV: Management of Change Evaluation
List of activities as a guideline copy
Customer/Regulatory notification form
2.6 Annexure-VI: Justification note
For the delay in closing of management of change
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