INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Bridge regulatory gaps in visual inspection and improve product quality by managing defects throughout the product lifecycle. Get a better understanding of how a centralized data repository can help.

  • Move your visual inspection processes into the Pharma 4.0 era with a digital system that provides data integrity and full audit trails to aid in compliance.

  • The Thermo Scientific™ Versa Flex and Versa Flex GP checkweighers are designed to improve accuracy and reliability, decreasing maintenance and product giveaway. Our global manufacturing and service teams enable a high level of solutions and service support wherever you do business.

  • A helium based test method for verifying the integrity of a blister card holding drug product has been proven to be the most effective approach due to the extreme sensitivity offered. The test method relies on detecting helium sealed in the package system as it escapes through micro-channels in the package. A test sequence begins by placing the package in the test fixture and a vacuum is quickly drawn. The resulting pressure differential causes helium to escape through potential holes or cracks in the package.

  • As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.