| 7.3 | DESIGN & DEVELOPMENT |
| 7.3.1 | Planning |
| 7.3.2 | Input |
| 7.3.3 | Output |
| 7.3.4 | Review |
| 7.3.5 | Verification |
| 7.3.6 | Validation |
| 7.3.7 | Change Control |
7.3.1 Design and development planning:
Design and Development planning is done by the Developmental
Project Lead. Detailed planning for complex processes may require inputs from
other areas such as consultant, subject expert, regulatory affairs, engineering
etc. Project Lead is also responsible for establishing stage wise tentative
timeline for the project.
The process of design and
development include:
– Defining an objective
– Determination of
critical quality attributes (CQA)
– Risk assessment
– Development of
experimental design (Design of Experiment)
– Designing and
implementing control strategy
– Continuous improvement
Review, verification and validation (wherever applicable) is
performed for each design and development stage. This ensures the availability
of the resources, capabilities, suggested timeframe for execution of each stage
with deliverables and further improves the plan during the course. This is a
continuous process and can be performed under project monitoring plan.
The Project Lead ensures that the project plan is executed
only after responsibilities and authorities for each stage are assigned and
understood.
Modes for communication for proper flow of information
between different groups are defined in communication plan.
The project plan evolves
during entire developmental process and it is the responsibility of the project
lead to update and communicate any modifications and changes in the plan.
7.3.2 Design and development inputs
Inputs relating to product requirements are determined and
records of such requirements are either attached to or referred in the project
development plan.
The inputs for product
requirements considered (but not limited to) are:
functional
and performance requirements,
applicable
statutory and regulatory requirements,
where
applicable, information derived from previous similar designs, and
other requirements
essential for design and development.
These inputs are reviewed for adequacy.
The project lead ensures
that the requirements of the product defined above are complete, unambiguous
and not in conflict with each other.
7.3.3 Design and development outputs:
The outputs of design and
development shall
a) meet the input
requirements for design and development,
b) provide appropriate
information for purchasing, production and service provision,
c) contain or reference
product acceptance criteria, and
d) specify the characteristics of the product that are
essential for its safe and proper use.
The above outputs of
design and development plan are suitability for verification against the design
and development input and are approved prior to release.
7.3.4 Design and development review:
Design and development
plan and project progress are reviewed as per design and development
review/verification plan. The review is targeted to
a) to evaluate the ability
of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.
The review is performed by review committee which comprises
of different disciplines/ functions concerned with design and development stage
being reviewed. The meeting is coordinated by design and development lead. The
committee also includes member form safety department
(biological/ chemical/ occupational) if deemed necessary by the developmental
stage under review.
The records of the review
and necessary actions are maintained. Any modification, change/update are
conveyed to all the interested parties.
7.3.5 Design and development verification:
The design and development
output is verified against design and development input to verify that the
requirements of input are met in the output. This verification is performed as
per design and development review and verification plan. The records of these
verifications are maintained.
7.3.6 Design and development validation:
The resulting product form
design and development stage is validated to ensure that the resulting product
is capable of meeting the requirements for the specified application or
intended use. The validation proves that the product developed form design and
development meet the specifications. The results of design and development
validation and necessary actions are maintained.
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