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Change Triggers for changes and the related  Trigger for change Change proposal COMPLIANCE

proposal evidence are clearly documented: Enhancement in It is proposed to increase batch size of product XYZ

upgrades to equipment or facilities manufacturing tablet from x kg to 3x kg as capacity of

improvements in raw materials capacity manufacturing and packaging equipments is

improvements in manufacturing sufficient.

performance and consistency (to reduce TRIGGER FOR CHANGE

variability, improve yield, Enhancement in manufacturing capacity

etc.)enhancements in manufacturing OBJECTIVES:

capacity, corrections of quality issues To achieve monthly production target of 2.0 million

addressing deviations, complaints, CAPA, Tablets of product xyz.

product quality review, operational or To increase manufacturing capacity of Tablets up to

management review, new regulations, 100 % within 06 months.

compliance gaps, implementing innovation SCOPE:

or continual improvement initiatives. The change will cover following process stages

 Procurement of materials, Dispensing,

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Granulation, Compression, Coating,

Packaging and Distribution.

EXPECTED OUTCOMES:

1. Raw material dispensing, Granulation and

Coating will be done in one go.

2. There will be the requirement of raw

material and packaging material trolley s,

storage drums and pallets.

3. Space is available in in-process stores but

lead time of product storage (Granules and

tablets) and PPM in WIP store of packaging

area will be increased.

4. Less frequent line clearance activity during

process stages.

5. Reduced change over time in compression

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and blistering

6. Less frequent cleaning verifications.

7. QC approval time will also be reduced for

bulk and intermediate stages of the process.

8. Lead time for compression and packaging

will be Increased.

9. Overtime working will be required in

packaging. No overtime in compression as

machine remains idle for 15 days in a month.

10. More hiring of temporary staff for overtime.

11. Partial finished goods transfers will be done

due to shortage of space in packaging area.

12. Risk of un-released goods may cause goods

shortages if QC release affects due to some

reason.
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13. Increased cash flow as scale up is related

with increased market demand.

( Procurement of large quantities of

materials)

ANTICIPATED BENEFITS:

1. Planning will become easier.

2. Time and cost saving.( Manufacturing and

testing etc)

3. No major investment (e.g. purchase of

machinery or construction of new area etc.)

will be required to achieve market demand.

The objectives, scope, expected outcomes COMPLIANCE

  and anticipated benefits of the proposed  

change are documented. 

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POTENTIAL IMPACT OF PROPOSED CHANGE TO

OTHER PRODUCTS/PROCESSES/SYSTEMS OR SITES.

( Request for potential impact assessment in the

form of Separate sheets should be provided to

relevant stake holders along with Change proposal

request.

 Potential impact on other processes.

The change will have direct impact on

material procurement and storage process,

material issuance process, product

manufacturing and packaging processes and

finished goods storage and distribution

processes.

Potential Impact on material procurement

process with rationale.

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a. Supply chain department confirmed

that they have contacted all vendors

of raw and packaging materials with

new materials requirements and

ensured that all materials will be

available if change is implemented

after 2 months.

Potential Impact on material storage and

issuance processes with rationale.

a. Warehouse Manager confirmed that

there will be no issue of material

storage as sufficient space and

pallets are available in warehouse

for storage of materials whereas all

requirements related to material

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issuance will be completed within 2

months time frame. ( e.g.

arrangement of more trolleys and

locks)

Potential Impact on product manufacturing

and packaging processes with rationale.

a) There will be no impact on

granulation process as equipment

capacities are sufficient for revised

batch size, drums and pallets for

granules storage are available.

There is sufficient space available

in granule store.

b) There will be no impact on

compression process as machine

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remains idle for 15 days in a month

so requirements of other products

for compression will not be affected.

Drums and pallets for tablets

storage are available. There is

sufficient space available in tablet

store.

c) There will be no impact on product

coating process as coating pan

capacity is sufficient for revised

batch size. Drums and pallets for

tablets storage are available. There

is sufficient space available in

tablet store.

d) There will be no impact on tablet

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blistering as same machine will be

used for revised batch size. The only

factor which will have impact is the

lead time of blistering as machine

speed is constant so lead time will

increase with revise batch size

which will have direct impact on

target production of other products.

This factor can be overcome by

doing overtime shift for blistering

and packaging.

Potential Impact on finished goods storage

and distribution processes with rationale.

a) Warehouse manager confirmed that

sufficient space and pallets are

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available in Quarantine area,

Released area and Rejected store,

The area for storage of returned

goods is also very spacious whereas

area of recalled products is small

but there is another adjacent room

which can be used for storage of

recalled products of large batch

size. Engineering department

ensured that space of recalled area

will be increased within 06 months.

b) There will be no impact on product

distribution process as supply chain

confirmed that they have contacted

with logistics providers and

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Distributors and there will be no

issue of space in vehicles and

Distributors warehouses for revised

batch size.

 Potential impact on other products.

The change could have impact on 05 other

products mentioned below.

I,II,III,IV and V.

As same compression and blistering

machine is used for production. The lead

time of compression will be increased for

new batch size but as machine remains idle

for 15 days in a month so there will be no

impact on compression process of other

products. The only impact of this change

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will be on blistering machine so impact of

long blistering hours on production targets

of 05 products can be overcome by doing

overtime in blistering and packaging

process.

There will be no impact on testing of other

products.

 Potential impact on systems.

There will be no additional requirement of

separate area, HVAC system, water system,

steam, Gases, and compressed air, The only

impact of the change is that working hours

in compression, blistering and packaging

process will be increased so HVAC

operational time and consumption of

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electricity will be increased. In case of

electricity failure in overtime shift,

generator fuel will be consumed for power

backup.

The change will have impact on

computerized system and company

documentation system e.g. BOMs in

software will be revised; new BMR and BPR

will be prepared.

There will be no impact on EHS system.

 Potential impact on other sites.

As there is one manufacturing plant

therefore there will be no impact of this

change on other sites.

 Potential impact on PENDING/APPROVED

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filling and regulatory commitments.

( To be provided by QA Regulatory section)

The potential impacts of the proposed COMPLIANCE

change to other products, processes,

   
systems or sites are assessed and

rationales are documented.  

  Relevant experts and stakeholders (e.g.,  

various subject matter experts (SMEs),

specific departments) are involved in CHANGE PROPOSAL SUBMISSION

change proposal development and Change proposed by. ______________

approval.  (Name/Designation/Department/Sign/Date)

Stakeholders involved in change proposal

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(Name/Designation/Department)

1-__________________________

(Enclose signed copy of Potential impact

assessment)

2-__________________________

(Enclose signed copy of Potential impact

assessment)

3-__________________________

(Enclose signed copy of Potential impact

assessment)

4-__________________________

(Enclose signed copy of Potential impact

assessment)

5-__________________________

(Enclose signed copy of Potential impact

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assessment)

6- _________________________

(Enclose signed copy of Potential impact

assessment)

Number of stake holders involved in change

proposal:______

CHANGE CONTROL REVIEW AND IMPACT

EVALUATION

FORMAL IMPACT EVALUATION

DESCRIPTION OF CHANGE PROPOSAL:

INITIATOR
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(Name/Designation/Department)

Impact Assesment

Change reviewed by.

_____________________________

(Name/Designation/Department/Sign/Date)

_____________________________
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(Name/Designation/Department/Sign/Date)

_____________________________

(Name/Designation/Department/Sign/Date)

CHANGE CATEGORY RECOMMENDED:

(MAJOR/MINOR)

…………………………………………….

Recommendation :---------------------(ACCEPT/REJECT)

RATIONALE FOR CHANGE PROPOSAL ACCEPTANCE OR

REJECTION

…………………………………………………………………………..

…………………………………………………………………………..

…………………………………………………………………………..
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CHANGE PROPOSAL FINAL DECISION

(APPROVED/REJECTED):_____________________________

CHANGE CATEGORY ASSIGNED:

(MAJOR/MINOR)

…………………………………………….

RATIONALE FOR CHANGE PROPOSAL ACCEPTANCE OR

REJECTION

…………………………………………………………………………..

…………………………………………………………………………..

…………………………………………………………………………..

Final decision taken by. _____________________________

(Name/Designation/Department/Sign/Date)

Final decision taken by. _____________________________

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(Name/Designation/Department/Sign/Date)

Final decision taken by. _____________________________

(Name/Designation/Department/Sign/Date)

…………………………………………………………………………..

The potential impacts to pending/approved

  filings and regulatory commitments are  

addressed. 

  The system ensures that changes are  

proposed in a timely manner, that proposed

changes are formally evaluated, and that a

decision to accept or reject the proposal is

documented. For rejected change proposals,

the system ensures that the rationales for

those rejections are documented, and that

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continued risks are adequately managed.

Change risk The Change Management system ensures  

assessments that appropriate science and knowledge-

based risk assessments are performed and

documented for changes, taking into

account the points below:  

The level of rigor, effort (e.g.

testing, validation, review) and

documentation is commensurate with the

level of risk. 

Risk assessments adequately

assess the potential risks and benefits of

changes to product quality, safety and

efficacy. 

Risk assessments adequately

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assess potential risks and benefits to other

products, processes, systems. 

Risk assessments identify and

document current and needed risk

controls. 

Changes and their risks are

assessed using current product and

process knowledge. Appropriate data and

information are used (or generated, if

needed) to support such risk

assessments.   

Change categorizations are

appropriate and based on the level of risk.

Change The outcomes of risk assessments and the  

planning and assigned risk levels drive change planning,

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implementati prioritisation, implementation, and their

on timelines. 

Data to support the change, as well as

acceptance criteria and change

effectiveness criteria, are pre-defined in

change planning. These may include

   
continuous process verification (CPV) and

statistical assessments, (e.g. CpK/PpK) etc.,

to aid with the quantitative assessment of

risk control. 

Risks with the current state (until changes

are implemented) and any risks that might

   
be temporarily introduced during the change

process are adequately assessed. 

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Interim controls (short-term measures) are

identified and implemented in a timely

  manner to monitor/mitigate risks associated  

with the current situation (until change

implementation).

Identified risk control measures are

  adequately implemented in a timely  

manner. 

The system ensures that approval to

  proceed with change implementation is  

documented. 

  Relevant risk assessments are reviewed and  

are updated after the implementation of

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changes. 

Relevant and timely updates are made to

regulatory filings, when appropriate (e.g.

   
annual reporting must include all changes of

relevance to filings).

Change Prior to change closure:   Changes meet  

review and their intended objectives and pre-defined

effectiveness effectiveness criteria. Any deviations from

those criteria are adequately assessed,

accepted and managed/justified.  Whenever

possible, quantitative data are leveraged to

objectively determine change effectiveness

(e.g. statistical confidence and coverage). 

As part of the quality risk management

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activities, residual risks are assessed and

managed to acceptable levels, and

appropriate adaptations of procedures and

controls are implemented.  Any unintended

consequences or risks introduced as a

result of changes are evaluated,

documented, accepted and handled

adequately, and are subject to a pre-defined

monitoring timeframe.

  Prior to or after change closure:  Any post-  

implementation actions needed (including

those for deviations from pre-defined

acceptance criteria and/or CAPAs) are

identified and adequately completed. 

Relevant risk assessments are updated

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post-effectiveness assessments. New

product/process knowledge resulting from

those risk assessments are captured in the

appropriate Quality and Operations

documents (e.g. SOPs, Reports, Product

Control Strategy documents, etc.)  Changes

are monitored via ongoing monitoring

systems to ensure maintenance of a state of

control, and lessons learned are captured

and shared/communicated.