Manufacturing and Distribution

Improving the efficiency of manufacturing processes can produce significant financial benefits for pharmaceutical and biotechnology companies. Increased costs and production times due to rejected batches and rework are major issues faced daily by manufacturing operations. These issues are often caused by the ineffective scale-up of development processes to commercial manufacturing, inadequate understanding of the process, and the lack of tools to effectively control and optimize the process. The US Food and Drug Administration recognizes that the quality standards of the industry as a whole falls far short of other industries and in September 2004, issued guidance on Process Analytical Technology (PAT) to encourage voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance programs. (http://www.fda.gov/cder/guidance/6419fnl.pdf)

Improving the safety and security of the nation's drug supply throughout the distribution channel is another area where the FDA is actively involved. In February 2004 the FDA issued a report on Combating Counterfeit Drugs, followed by a Compliance Policy Guide in November 2004 that promotes use of Radio Frequency Identification Technology (RFID).

In the past change hasn't been easy. Until recently, the FDA exercised extensive control over virtually very aspect of the manufacturing process. In order to mitigate a perceived or sometimes very real regulatory compliance risk, companies have been reluctant to change processes or equipment that could have a positive impact on overall quality and performance. Now, the FDA will be applying risk-based principles to their oversight of manufacturing processes, manufacturing site inspections, and product quality review processes. These changes are intended to facilitate continuous improvement in pharmaceutical manufacturing and improve availability of new drugs while increasing product quality and process efficiency. One constant is the agency's focus on the proliferation of quality systems throughout pharmaceutical manufacturing to ensure the integrity of the end product.

How Patni Can Help
Patni focuses on providing services to support the complete quality systems life cycle from workflow analysis, requirements definition, system selection, implementation, customization, validation, and ongoing support. Our expertise covers mission-critical quality systems including: