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Infrastructure provision remains the definitive measure of
development around the world, yet engineers often only get involved
in the creation of infrastructure after the important planning
decisions have already been made. This is an introduction to the
principles and procedures necessary for infrastructure planning in
rapidly developing regions. It covers the technical methods
required in planning for infrastructure provision from base-line
studies and problem definition through to the specification for a
set of projects. The book also discusses the political factors that
affect the decision making process and demonstrates, through case
studies, how the technical and political perspectives come together
in the finished plan.
Scale up is generally defined as the process of increasing batch
size. In process scale up a formula is transformed into a viable,
robust product by the development of a reliable and practical
method of manufacturing that effect the orderly transition from
laboratory to routine processing in a full-scale production
facility. It must include a close examination of the formula to
determine its ability to withstand batch-scale and process
modification. So process scale up of Metformin HCL tablet includes
Trial Batches, Exhibit Batches and Validation Batch. After these
batches produce large scale up Metformin HCL Tablets. During the
scale up process controls are evaluated, valuated and finalized in
addition, appropriate records and report are issued to support good
manufacturing practices and to provide the historical development
of the production, formulation, process equipments train, and
specification.
Validation is defined as the establishing of documented evidence
which provides a high degree of assurance that a planned process
will consistently perform according to the intended specified
outcomes. Validation studies are performed for analytical tests,
equipment, facility systems such as air, water, steam, and for
processes such as the manufacturing processes, cleaning,
sterilization, sterile filling, lyophilization, etc. There will be
a separate validation for the lyophilizer as an equipment item and
for the lyophilization process; for the cleaning of glassware and
the cleaning of the facility; and for the sterilization process and
for the sterility test. Every step of the process of manufacture of
a drug product must be shown to perform as intended. Validation
studies verify the system under test under the extremes expected
during the process to prove that the system remains in control.
Once the system or process has been validated, it is expected that
it remains in control, provided no changes are made. In the event
that modifications are made, or problems occur, or equipment is
replaced or relocated, revalidation is performed.
The Pieces of Heart is simply a book of Hindi poetry, all about
feelings of a person growing from twenty-one of his age and start
expressing feelings in the shape of poems and Ghazals, fantasizing
the things being hobby of the writer. Family and friends cheer and
make their appreciations, which make the author strongly convert
the ideas into the poetry. Deepak feels that the poetry is nothing
but a thought process or a feeling that could be anywhere, about
anyone, anything, like one can love his parents, like someone's
face or work, and start getting affection for it. Deepak says he
always made his words through heart, a most precious part God gave.
Where he can take anything and from where only he could be able to
give anything. Now he is giving here. PIECES OF HEART Before anyone
reads this book, Deepak wants to share something. "These pieces are
of 'my heart, ' and I hope after reading this book, these pieces
will become pieces of your heart." In short, this is all about the
feelings that touched my heart. This is my first creation and an
appreciation will encourage me to continue.
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