GlaxoSmithKline Process Using Pall Rapid Microbiological Test Is First Approved By FDA
Pall have announced that the FDA have granted GlaxoSmithKline (GSK)approval to use the Pallchek™ Luminometer as part of the quality control process for its prescription nasal spray product in its Parma, Italy facility. The Pall rapid test enables GSK to release product to market up to four days earlier than before.
GSK is the first pharmaceutical company to obtain approval to release a prescription product to market using a rapid detection technology under the FDA Process Analytical Technologies (PAT) program. The FDA PAT initiative is designed to encourage manufacturers to adopt new analytical technologies to better control manufacturing processes and provide greater assurance of product safety. The Pallchek Luminometer uses a proprietary rapid method to detect microbiological contamination. Results are known within 24 hours of testing versus the three to five days traditional technologies require.
The Pallchek Luminometer identifies the presence or absence of microbiological contamination in less than 24 hours by assessing the presence of a specific molecular marker of the test organisms. This means pharmaceutical companies can take faster corrective action should contamination be identified. The Pallchek Luminometer provides a simple, easy-to-use and cost-effective tool to monitor microbiological contamination in final products, Water For Injection, raw materials and the manufacturing environment. The process approval received by GSK Parma covers the use of the Pallchek Luminometer for specific non-sterile products as well as Pharmaceutical Grade Water.
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