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The
challenge Quality Assurance Managers are facing today is
how to keep pace with rapidly changing regulatory needs
and, at the same time, to increase Batch Release output
with limited resources. Pharmaceutical Manufacturing can
earn more profit from learning to think in terms of
Lean, a philosophy that aims to eliminate waste. Lean
attacks waste mainly by shortening the time between the
customer order and shipment. Based on a customer-focused
view, six steps can provide a strong foundation for any
organization that wants to incorporate Lean into its
operating philosophy. These steps in Lean thinking can
be best evaluated at the producer end by Authenticateing
and reviewing each step one at a time.
1. Value
2. Value Stream
3. Flow
4. Pull
5. Perfection
6. Replication
Lean thinking can best start by giving due consideration
to value, which ultimately is the customer’s
requirement. The value of any product (goods or
services) is defined by customer needs and not by any
non-value-added activity at the supplier or producer
end. That is, the customer is prepared to pay for
operations by producers or their suppliers that
transform the product in a way that is meaningful to the
customer. Customers do not want to pay for “waste at the
producer end.
1. Value (Specifying)
Value is determined by the customers who want to buy the
right product with the right quality at the affordable
price. That is, the product must be “right” every time –
from design to manufacture, from delivery to error-free
operation. Lean work on making their processes right by
eliminating waste – something no customer wants to pay
for.
In Case of Pharmaceutical Products Value is defined by
the FDA (customer) for drugs is contained in five types
of documents utilized by the FDA to ensure the
manufacturers’ products are safe, effective, have the
identity and strength, and meet the quality and purity
characteristics as intended: FD&C, 21 CFR and Federal
Register, CPGMs, other manuals, and Human Drug cGMP
Notes issued by the FDA. While linking the term “value”
generally with Batch Release in Pharma, In accordance
with the FDA documents referenced above and industry
standards, the following components are to be reviewed
for the value for the customer, as it relates to any
specific product
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