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CH.SRINIVASA REDDY
M.SC
 Change control is another well-known CGMP
concept that focuses on managing change to
prevent unintended consequences. The
CGMP regulations provide for change control
primarily through the assigned responsibilities
of the quality control unit
 Certain major manufacturing changes (e.g.,
changes that alter specifications, a critical
product attribute or bioavailability) require
regulatory filings and prior regulatory approval
(21 CFR 314.70, 514.8, and 601.12).
Effective change control activities (e.g.,
quality planning and control of revisions to
specifications, process parameters,
procedures) are key components of any
quality system. In this guidance, change is
discussed in terms of creating a regulatory
environment that encourages change
towards continual improvement.
 13. CHANGE CONTROL
 13.10 A formal change control system should be
established to evaluate all changes that may affect
the production and control of the intermediate or
API.
 13.11 Written procedures should provide for the
identification, documentation, appropriate review,
and approval of changes in raw materials,
specifications, analytical methods, facilities,
support systems, equipment (including computer
hardware), processing steps, labelling and
packaging materials, and computer software.
13. CHANGE CONTROL
13.14 When implementing approved
changes, measures should be taken to
ensure that all documents affected by the
changes are revised.
13.15 After the change has been
implemented, there should be an
evaluation of the first batches produced or
tested under the change.
 13. CHANGE CONTROL
 13.12 Any proposals for GMP relevant changes should be
drafted, reviewed, and approved by the appropriate
organisational units, and reviewed and approved by the quality
unit(s).
 13.13 The potential impact of the proposed change on the
quality of the intermediate or API should be evaluated. A
classification procedure may help in determining the level of
testing, validation, and documentation needed to justify
changes to a validated process. Changes can be classified
(e.g. as minor or major) depending on the nature and extent of
the changes, and the effects these changes may impart on the
process. Scientific judgement should determine what
additional testing and validation studies are appropriate to
justify a change in a validated process.
13. CHANGE CONTROL
13.16 The potential for critical changes to
affect established retest or expiry dates
should be evaluated. If necessary, samples
of the intermediate or API produced by the
modified process can be placed on an
accelerated stability program and/or can
be added to the stability monitoring
program.
13. CHANGE CONTROL
13.17 Current dosage form manufacturers
should be notified of changes from
established production and process control
procedures that can impact the quality of
the API.
Change Control
A system to propose, review, justify,
evaluate, document, implement, approve,
and close changes to technical equipment
used in the manufacture of APIs and
intermediates to ensure a constant
qualified status of the systems concerned.
Emergency change
An unplanned change of a piece of
equipment as a result of an emergency,
which needs to be repaired immediately in
order to maintain personal or
environmental safety or preserve the
quality of the product.
 "Like for like" Change
 Replacement of a piece of equipment by
another with identical characteristics and
function (same material of construction, size,
type, etc., but not necessarily from the same
manufacturer). The fact if equipment is like for
like needs to be thoroughly reviewed, justified
and recorded with written approval of the
Process Owner, QU and if applicable
Regulatory Affairs. These changes can be
considered minor impact changes
Major impact changes A change expected
to have a potential impact on product
quality. Changes with an uncertain impact
level should be handled as major impact
changes.
Minor impact changes A change not
expected to have an impact on product
quality. Also called Standard change.
 Process owner The person who has the
ultimate accountability for the system which is
subject of the proposed change.
 Quality Unit (QU) An organisational unit
independent of production that fulfils both
Quality Assurance and Quality Control
responsibilities.
 Technical Change A technical change is a
planned modification (expansion,
replacement, removal, addition) with respect
to qualified equipment (defined state of a
piece of technical equipment).
 Technical Equipment: Manufacturing
equipment, utilities, computerized systems
[e.g. Process (PLC) and Distribution and
Control Systems (DCS)] and facilities used in
the manufacturing of APIs.
 Impact of Changes on affected Systems
 Important repairs and maintenance work,
such as replacement of major parts of
equipment, may affect the performance of the
process and the quality of the product.
Impact of Changes on affected Systems
Rearrangements in manufacturing areas
(for example rooms with defined
environmental conditions) and/or support
systems (utilities, e.g.: HVAC systems,
systems for water, steam, CIP/SIP-
systems) may result in changes in the
process and therefore,
revalidation/requalification may be
necessary.
 Regulatory Affairs
 Every technical change with major impact
should be assessed at least by RA. RA is
required to assess the potential impact on
regulatory filing. RA decides about the
measures to be taken to document the
change appropriately. In case an approved
change has impact on regulatory filing it is the
responsibility of the RA department to take
appropriate action.
Technical Department : The TD is required
to evaluate and approve the (technical)
impact of a proposed change.
Criteria for criticality
can directly contact the product or product
components, and is not considered a like
for like change
can directly affect the product quality by
normal operation or control (e.g., impurity
profile, crystal form and size, residual
solvent or stability of the API);
indicates and records alarm functions
critical to the process
is used to record, output or archive data for
batch records or labels and other GMP
documentation or labels;
is used to demonstrate compliance with
the registered process;
can influence the quality and performance
of support systems (e.g., water, steam,
HVAC, etc.)
is used to ensure access control to critical
data or functions (user identification and
authenticity)
 is used to perform analytical investigations
that are relevant for batch release
 is used for critical calculations (e.g., analytical
data that are relevant for batch release);
 is used for batch release
 is used to control batch status or shelf life;
 is used to control the production process
(recipe/process description);
 is used to transfer critical data (interface) to
another quality relevant system;
 is used to give information about the quality of
the product (e.g. printers for process related
data);
 is used to ensure or record critical conditions
for warehouses
 is used to control maintenance or calibration
of critical equipment
 is used to create, modify, record, document,
review, approve GMP data;
 Concept Note on a Document prepared by the PIC/S
QRM Expert Circle on ‘How to Evaluate / Demonstrate
the Effectiveness of a Pharmaceutical Quality System in
relation to Risk-based Change Management’
 Guidance for GMP Inspectors on evaluating the
effectiveness of the PQS in relation to riskbased change
management was considered important, given the
requirements of the PIC/S GMP Guide in these areas
(see below). This specific topic had not been dealt with
extensively in the existing training materials of the QRM
Expert Circle up until then, but it has become a topic of
high relevance at this time, given the pending agreement
of ICH Q12, for which PQS effectiveness in relation to
risk-based change management is a core concept
 The PIC/S GMP Guide requires companies to
demonstrate the effectiveness of their PQS,
and it requires the application of QRM
principles to change control activities.
 Principle: …there must be ‘a comprehensively
designed and correctly implemented PQS
incorporating GMP and QRM. It should be
fully documented and its effectiveness
monitored’
1.3 ...’the effectiveness of the system is
normally demonstrated at the site level’
1.5 ‘Senior management has the ultimate
responsibility to ensure an effective PQS is
in place...’
1.4 (xii) Arrangements [should be] in place
‘for the prospective evaluation of planned
changes and their approval prior to
implementation
 Annex 15 states:
 11.1. ‘The control of change is an important
part of knowledge management and should
be handled within the pharmaceutical quality
system.’
 11.4. ‘Quality risk management should be
used to evaluate planned changes… and to
plan for any necessary process validation,
verification or requalification efforts.’
 Details of the Document on How to Evaluate / Demonstrate
PQS Effectiveness for Riskbased Change Managemen
 The key elements that could be included in risk-based change
proposals.
 The assessment by the pharmaceutical manufacturer of
change proposals from a risk perspective, where the level of
rigor, effort and documentation is commensurate with the level
of risk, where risk assessments adequately assess potential
risks and benefits of changes to product quality, safety and
efficacy, and where those risk assessments assess the
potential risks and benefits to other products, processes,
systems.
The categorisation by the pharmaceutical
manufacturer of changes based on the
level of risk.
The role of change planning and
implementation, where the outcomes of
risk assessments and the assigned risk
levels drive change planning, prioritisation,
implementation, and their timelines
 Change review and effectiveness
assessments at the pharmaceutical
manufacturer, in terms of whether changes
meet their intended objectives and pre-
defined effectiveness criteria, where residual
risks are assessed and managed to
acceptable levels, and where changes are
monitored via ongoing monitoring systems to
ensure maintenance of a state of control.
 Anticipated Benefits of the Document
 The document will deliver benefits in several
ways. For the QRM Expert Circle, for
example, it can serve as the basis for the
development of practical training materials
and case studies for GMP inspectors in
relation to inspecting the effectiveness of the
PQS with regard to risk-based change
management activities
 Anticipated Benefits of the Document
 In addition, the principles set out in the document
could be used to assist in updating the current
PIC/S QRM Aide Memoire, to delineate a risk-
based approach for inspecting change
management programmes
 In addition, the PIC/S GMP Guide requires
companies to use risk-based approaches to the
management of changes. Therefore, PQS
effectiveness and risk-based change management
go hand-in-hand and indeed, they complement
each other..
There are additional benefits from having
guidance in this area also. ICH Q10 sets
out the potential for risk-based regulatory
oversight for companies which
demonstrate that an effective PQS is in
place. ICH Q10 indicates that, if the
principles and concepts of ICH Q8, Q9 &
Q10 are adopted
if the effectiveness of the PQS is
demonstrated, then there may be
opportunities for some form of risk-based
regulatory oversight from regulators to
promote lifecycle continual improvements.
This concept was also a cornerstone
principle behind FDA’s 21st Century GMP
initiative, published in 2002.
Any proposal to good manufacturing
process)relevant changes related to
SOP,Forms,Facility,equipment
instrument,process,specification&MOA and
method of analysis. and other shall be
proposed ,reviewed and evaluated by the
appropriate departments.and reviwed
approved by the QA department.
 Change shall be planned to always occur and
there fore action shall be prospectively
defined and approved prior to carrying out
change.
 A deviation is not a plan and there fore refers
to un international changes or occurrence are
from an approved instruction or established
stranded. the reference to the term deviation
Shall be same as incident under company
quality system.
Change control process shall be a formal
system by which qualified representative of
appropriate discipline review and approve
change request. the review and approval
shall
Include assessment .
The ownership of the change shall be with
the Head of the department, who is
responsible for initiating the change in
“Change Control Initiation Form” .
Identification of ownership of the change
and consent to be taken from the other
departments is mentioned in “Change
Control Initiation Matrix.
Initiation of Change Control
Change Control Initiator shall describe the
following in “Change Control Initiation
Form”.
 Name of the Initiator department and Name of
the product and Stage of production
 Code of change in section
 The change(s) proposed
 Identification of change(s) either temporary
(with period) or permanent in section
 Reason(s) for proposing the change
 Tentative date of implementation of change
with batch number
 Initiator department shall attach supporting documents (if applicable)
based on proposed change.
 The following types of documents are to be attached with “Change
Control Initiation Form”, but not limited to :
• R&D / Process Development Laboratory data in case of
manufacturing process change.
• Recommendation from other agencies / departments.
• Past Trend Analysis Data.
 Audit Observation
• Change in Regulatory norms / guidelines.
 The type of reason may be as follows, but not limited to
 Regulatory requirement.
 Good manufacturing practices implementation / enhancement.
 Quality improvement.
 Capacity enhancement.
 Introduction of new product in the existing Facility.
 Cost reduction.
 Automation.
 Aging of Facility.
 To manage unavoidable situation.
 Market requirement.
 Safety requirement
 CHANGE CONTROLE INTIATION FORM

Date;
 1.1 Change initiation change
control No: CCIF

1.2 INITIATION DEAPARTMENT

1.3 CHANGE RELATED TO □ BATCH RECORDS □ PROCESS □ FACILITY
 □ SPECIFICATION □ DOCUMENT □
Equipment
 □ Test procedure □ others



1.4 Existing documents / document title :

 Existing system current version _______ to

 Ref deviation if applicable __________
 IMPLEMENTATION APPROVED CHANGE:
 After completion evaluation and approval of
process QA Representative shall
communicate
The same to request to implement approve
of the change.
requester shall refer the details of
instructions/remarks/actions/documents
identified evaluators and approves CCF
during evaluation and approval.
Evaluation of change :
Request shall forward the change control
to identify the internal department personal
for evaluation.
During evaluation any information required
the evaluator shall contact requester .each
evaluator shall give their decision.
Closing of change control.
After completion of post change review by
request department, QA Representative
shall
Review the results and supporting data.
Verify the completion of required activities /
documents identified during the evaluation
and approval of change and record details
of verification in change control.
 The control of change is an important part of
knowledge management and should be handled within
the pharmaceutical quality system.
 Written procedures should be in place to describe the
actions to be taken if a planned change is proposed to
a starting material, product component, process,
equipment, premises, product range, method of
production or testing, batch size, design space or any
other change during the lifecycle that may affect
product quality or reproducibility.
Where design space is used, the impact
on changes to the design space should be
considered against the registered design
space within the marketing authorisation
and the need for any regulatory actions
assessed.
 Quality risk management should be used to
evaluate planned changes to determine the
potential impact on product quality,
pharmaceutical quality systems,
documentation, validation, regulatory status,
calibration, maintenance and on any other
system to avoid unintended consequences
and to plan for any necessary process
validation, verification or requalification
efforts.
Changes should be authorised and
approved by the responsible persons or
relevant functional personnel in
accordance with the pharmaceutical
quality system.
Supporting data, e.g. copies of documents,
should be reviewed to confirm that the
impact of the change has been
demonstrated prior to final approval.
 Following implementation, and, where appropriate,
an evaluation of the effectiveness of change
should be carried out to confirm that the change
has been successful.
 Change Control. A formal system by which
qualified representatives of appropriate disciplines
review proposed or actual changes that might
affect the validated status of facilities, systems,
equipment or processes. The intent is to determine
the need for action to ensure and document that
the system is maintained in a validated state.
 Reference:
 Volume 4 EU Guidelines
 PHARMACEUTICAL INSPECTION
CONVENTION /CO-OPERATION SCHEME
 ICH HARMONISED TRIPARTITE
GUIDELINE Q7
 Technical Change Control Guideline – APIC
 Guidance for Industry Quality Systems
Approach to Pharmaceutical CGMP
Regulations

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Evaluate PQS Effectiveness for Risk-Based Change Management

  • 2.  Change control is another well-known CGMP concept that focuses on managing change to prevent unintended consequences. The CGMP regulations provide for change control primarily through the assigned responsibilities of the quality control unit  Certain major manufacturing changes (e.g., changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval (21 CFR 314.70, 514.8, and 601.12).
  • 3. Effective change control activities (e.g., quality planning and control of revisions to specifications, process parameters, procedures) are key components of any quality system. In this guidance, change is discussed in terms of creating a regulatory environment that encourages change towards continual improvement.
  • 4.
  • 5.  13. CHANGE CONTROL  13.10 A formal change control system should be established to evaluate all changes that may affect the production and control of the intermediate or API.  13.11 Written procedures should provide for the identification, documentation, appropriate review, and approval of changes in raw materials, specifications, analytical methods, facilities, support systems, equipment (including computer hardware), processing steps, labelling and packaging materials, and computer software.
  • 6. 13. CHANGE CONTROL 13.14 When implementing approved changes, measures should be taken to ensure that all documents affected by the changes are revised. 13.15 After the change has been implemented, there should be an evaluation of the first batches produced or tested under the change.
  • 7.  13. CHANGE CONTROL  13.12 Any proposals for GMP relevant changes should be drafted, reviewed, and approved by the appropriate organisational units, and reviewed and approved by the quality unit(s).  13.13 The potential impact of the proposed change on the quality of the intermediate or API should be evaluated. A classification procedure may help in determining the level of testing, validation, and documentation needed to justify changes to a validated process. Changes can be classified (e.g. as minor or major) depending on the nature and extent of the changes, and the effects these changes may impart on the process. Scientific judgement should determine what additional testing and validation studies are appropriate to justify a change in a validated process.
  • 8. 13. CHANGE CONTROL 13.16 The potential for critical changes to affect established retest or expiry dates should be evaluated. If necessary, samples of the intermediate or API produced by the modified process can be placed on an accelerated stability program and/or can be added to the stability monitoring program.
  • 9. 13. CHANGE CONTROL 13.17 Current dosage form manufacturers should be notified of changes from established production and process control procedures that can impact the quality of the API.
  • 10. Change Control A system to propose, review, justify, evaluate, document, implement, approve, and close changes to technical equipment used in the manufacture of APIs and intermediates to ensure a constant qualified status of the systems concerned.
  • 11. Emergency change An unplanned change of a piece of equipment as a result of an emergency, which needs to be repaired immediately in order to maintain personal or environmental safety or preserve the quality of the product.
  • 12.  "Like for like" Change  Replacement of a piece of equipment by another with identical characteristics and function (same material of construction, size, type, etc., but not necessarily from the same manufacturer). The fact if equipment is like for like needs to be thoroughly reviewed, justified and recorded with written approval of the Process Owner, QU and if applicable Regulatory Affairs. These changes can be considered minor impact changes
  • 13. Major impact changes A change expected to have a potential impact on product quality. Changes with an uncertain impact level should be handled as major impact changes. Minor impact changes A change not expected to have an impact on product quality. Also called Standard change.
  • 14.  Process owner The person who has the ultimate accountability for the system which is subject of the proposed change.  Quality Unit (QU) An organisational unit independent of production that fulfils both Quality Assurance and Quality Control responsibilities.  Technical Change A technical change is a planned modification (expansion, replacement, removal, addition) with respect to qualified equipment (defined state of a piece of technical equipment).
  • 15.  Technical Equipment: Manufacturing equipment, utilities, computerized systems [e.g. Process (PLC) and Distribution and Control Systems (DCS)] and facilities used in the manufacturing of APIs.  Impact of Changes on affected Systems  Important repairs and maintenance work, such as replacement of major parts of equipment, may affect the performance of the process and the quality of the product.
  • 16. Impact of Changes on affected Systems Rearrangements in manufacturing areas (for example rooms with defined environmental conditions) and/or support systems (utilities, e.g.: HVAC systems, systems for water, steam, CIP/SIP- systems) may result in changes in the process and therefore, revalidation/requalification may be necessary.
  • 17.  Regulatory Affairs  Every technical change with major impact should be assessed at least by RA. RA is required to assess the potential impact on regulatory filing. RA decides about the measures to be taken to document the change appropriately. In case an approved change has impact on regulatory filing it is the responsibility of the RA department to take appropriate action.
  • 18. Technical Department : The TD is required to evaluate and approve the (technical) impact of a proposed change. Criteria for criticality can directly contact the product or product components, and is not considered a like for like change
  • 19. can directly affect the product quality by normal operation or control (e.g., impurity profile, crystal form and size, residual solvent or stability of the API); indicates and records alarm functions critical to the process is used to record, output or archive data for batch records or labels and other GMP documentation or labels;
  • 20. is used to demonstrate compliance with the registered process; can influence the quality and performance of support systems (e.g., water, steam, HVAC, etc.) is used to ensure access control to critical data or functions (user identification and authenticity)
  • 21.  is used to perform analytical investigations that are relevant for batch release  is used for critical calculations (e.g., analytical data that are relevant for batch release);  is used for batch release  is used to control batch status or shelf life;  is used to control the production process (recipe/process description);
  • 22.  is used to transfer critical data (interface) to another quality relevant system;  is used to give information about the quality of the product (e.g. printers for process related data);  is used to ensure or record critical conditions for warehouses  is used to control maintenance or calibration of critical equipment  is used to create, modify, record, document, review, approve GMP data;
  • 23.  Concept Note on a Document prepared by the PIC/S QRM Expert Circle on ‘How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management’  Guidance for GMP Inspectors on evaluating the effectiveness of the PQS in relation to riskbased change management was considered important, given the requirements of the PIC/S GMP Guide in these areas (see below). This specific topic had not been dealt with extensively in the existing training materials of the QRM Expert Circle up until then, but it has become a topic of high relevance at this time, given the pending agreement of ICH Q12, for which PQS effectiveness in relation to risk-based change management is a core concept
  • 24.  The PIC/S GMP Guide requires companies to demonstrate the effectiveness of their PQS, and it requires the application of QRM principles to change control activities.  Principle: …there must be ‘a comprehensively designed and correctly implemented PQS incorporating GMP and QRM. It should be fully documented and its effectiveness monitored’
  • 25. 1.3 ...’the effectiveness of the system is normally demonstrated at the site level’ 1.5 ‘Senior management has the ultimate responsibility to ensure an effective PQS is in place...’ 1.4 (xii) Arrangements [should be] in place ‘for the prospective evaluation of planned changes and their approval prior to implementation
  • 26.  Annex 15 states:  11.1. ‘The control of change is an important part of knowledge management and should be handled within the pharmaceutical quality system.’  11.4. ‘Quality risk management should be used to evaluate planned changes… and to plan for any necessary process validation, verification or requalification efforts.’
  • 27.  Details of the Document on How to Evaluate / Demonstrate PQS Effectiveness for Riskbased Change Managemen  The key elements that could be included in risk-based change proposals.  The assessment by the pharmaceutical manufacturer of change proposals from a risk perspective, where the level of rigor, effort and documentation is commensurate with the level of risk, where risk assessments adequately assess potential risks and benefits of changes to product quality, safety and efficacy, and where those risk assessments assess the potential risks and benefits to other products, processes, systems.
  • 28. The categorisation by the pharmaceutical manufacturer of changes based on the level of risk. The role of change planning and implementation, where the outcomes of risk assessments and the assigned risk levels drive change planning, prioritisation, implementation, and their timelines
  • 29.  Change review and effectiveness assessments at the pharmaceutical manufacturer, in terms of whether changes meet their intended objectives and pre- defined effectiveness criteria, where residual risks are assessed and managed to acceptable levels, and where changes are monitored via ongoing monitoring systems to ensure maintenance of a state of control.
  • 30.  Anticipated Benefits of the Document  The document will deliver benefits in several ways. For the QRM Expert Circle, for example, it can serve as the basis for the development of practical training materials and case studies for GMP inspectors in relation to inspecting the effectiveness of the PQS with regard to risk-based change management activities
  • 31.  Anticipated Benefits of the Document  In addition, the principles set out in the document could be used to assist in updating the current PIC/S QRM Aide Memoire, to delineate a risk- based approach for inspecting change management programmes  In addition, the PIC/S GMP Guide requires companies to use risk-based approaches to the management of changes. Therefore, PQS effectiveness and risk-based change management go hand-in-hand and indeed, they complement each other..
  • 32. There are additional benefits from having guidance in this area also. ICH Q10 sets out the potential for risk-based regulatory oversight for companies which demonstrate that an effective PQS is in place. ICH Q10 indicates that, if the principles and concepts of ICH Q8, Q9 & Q10 are adopted
  • 33. if the effectiveness of the PQS is demonstrated, then there may be opportunities for some form of risk-based regulatory oversight from regulators to promote lifecycle continual improvements. This concept was also a cornerstone principle behind FDA’s 21st Century GMP initiative, published in 2002.
  • 34. Any proposal to good manufacturing process)relevant changes related to SOP,Forms,Facility,equipment instrument,process,specification&MOA and method of analysis. and other shall be proposed ,reviewed and evaluated by the appropriate departments.and reviwed approved by the QA department.
  • 35.  Change shall be planned to always occur and there fore action shall be prospectively defined and approved prior to carrying out change.  A deviation is not a plan and there fore refers to un international changes or occurrence are from an approved instruction or established stranded. the reference to the term deviation Shall be same as incident under company quality system.
  • 36. Change control process shall be a formal system by which qualified representative of appropriate discipline review and approve change request. the review and approval shall Include assessment . The ownership of the change shall be with the Head of the department, who is responsible for initiating the change in “Change Control Initiation Form” .
  • 37. Identification of ownership of the change and consent to be taken from the other departments is mentioned in “Change Control Initiation Matrix. Initiation of Change Control Change Control Initiator shall describe the following in “Change Control Initiation Form”.
  • 38.  Name of the Initiator department and Name of the product and Stage of production  Code of change in section  The change(s) proposed  Identification of change(s) either temporary (with period) or permanent in section  Reason(s) for proposing the change  Tentative date of implementation of change with batch number
  • 39.  Initiator department shall attach supporting documents (if applicable) based on proposed change.  The following types of documents are to be attached with “Change Control Initiation Form”, but not limited to : • R&D / Process Development Laboratory data in case of manufacturing process change. • Recommendation from other agencies / departments. • Past Trend Analysis Data.  Audit Observation
  • 40. • Change in Regulatory norms / guidelines.  The type of reason may be as follows, but not limited to  Regulatory requirement.  Good manufacturing practices implementation / enhancement.  Quality improvement.  Capacity enhancement.  Introduction of new product in the existing Facility.  Cost reduction.
  • 41.  Automation.  Aging of Facility.  To manage unavoidable situation.  Market requirement.  Safety requirement
  • 42.  CHANGE CONTROLE INTIATION FORM  Date;  1.1 Change initiation change control No: CCIF  1.2 INITIATION DEAPARTMENT  1.3 CHANGE RELATED TO □ BATCH RECORDS □ PROCESS □ FACILITY  □ SPECIFICATION □ DOCUMENT □ Equipment  □ Test procedure □ others    1.4 Existing documents / document title :   Existing system current version _______ to   Ref deviation if applicable __________
  • 43.  IMPLEMENTATION APPROVED CHANGE:  After completion evaluation and approval of process QA Representative shall communicate The same to request to implement approve of the change. requester shall refer the details of instructions/remarks/actions/documents identified evaluators and approves CCF during evaluation and approval.
  • 44. Evaluation of change : Request shall forward the change control to identify the internal department personal for evaluation. During evaluation any information required the evaluator shall contact requester .each evaluator shall give their decision.
  • 45. Closing of change control. After completion of post change review by request department, QA Representative shall Review the results and supporting data. Verify the completion of required activities / documents identified during the evaluation and approval of change and record details of verification in change control.
  • 46.  The control of change is an important part of knowledge management and should be handled within the pharmaceutical quality system.  Written procedures should be in place to describe the actions to be taken if a planned change is proposed to a starting material, product component, process, equipment, premises, product range, method of production or testing, batch size, design space or any other change during the lifecycle that may affect product quality or reproducibility.
  • 47. Where design space is used, the impact on changes to the design space should be considered against the registered design space within the marketing authorisation and the need for any regulatory actions assessed.
  • 48.  Quality risk management should be used to evaluate planned changes to determine the potential impact on product quality, pharmaceutical quality systems, documentation, validation, regulatory status, calibration, maintenance and on any other system to avoid unintended consequences and to plan for any necessary process validation, verification or requalification efforts.
  • 49. Changes should be authorised and approved by the responsible persons or relevant functional personnel in accordance with the pharmaceutical quality system. Supporting data, e.g. copies of documents, should be reviewed to confirm that the impact of the change has been demonstrated prior to final approval.
  • 50.  Following implementation, and, where appropriate, an evaluation of the effectiveness of change should be carried out to confirm that the change has been successful.  Change Control. A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action to ensure and document that the system is maintained in a validated state.
  • 51.  Reference:  Volume 4 EU Guidelines  PHARMACEUTICAL INSPECTION CONVENTION /CO-OPERATION SCHEME  ICH HARMONISED TRIPARTITE GUIDELINE Q7  Technical Change Control Guideline – APIC  Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations