Batch Release in Pharmaceutical Industry in Lean Thinking Concept

Francis Fernandes, Dr. Subhash Pande, Prof. P. N. Murty

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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