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Pharmaceutical drug development and commercial manufacturing is complex and risky. Packaging and drug delivery add challenges. With West by your side, you can find solutions to industry challenges such as:
Contamination control is the cornerstone of sterile drug product manufacturing. As therapies become more complex and patient safety expectations rise, regulators and standards-setting bodies are sharpening their focus on holistic contamination control strategies. When the European Union, World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised the GMP Annex 1 guidelines for sterile medicinal products, it raised the bar on expectations of manufacturers and their sterile product suppliers, by extension. Since the publication date, several other global jurisdictions have adopted these guidelines into their national law or developed complementary requirements.
In the complex world of pharmaceutical development, drug developers have a lot to think about. From formulation and testing to containment and delivery, every decision carries risk, cost, and long-term implications. Making these decisions can be overwhelming in and of itself — but when you consider that the timing of each choice can influence the overall drug timeline, the challenge intensifies. These complexities call for a forward-thinking approach — one that considers not just today’s choices, but the ripple effects they create across the entire drug product lifecycle.
That’s why it’s critical not just to make the right decisions for the moment, but the smart ones that enable a successful launch — and, more importantly, ensure the long-term success and sustainability of your drug product.
The RAPS Philadelphia Chapter, in collaboration with West Pharmaceutical Services, convened regulatory, quality, and industry professionals for a dynamic session focused on the implementation of the FDA’s Quality Management System Regulation (QMSR). Held at West’s Exton, PA facility, the evening provided a collaborative forum for industry professionals navigating the transition from the longstanding Quality System Regulation (QSR) to the newly aligned framework modeled on ISO 13485.
Contamination control is the cornerstone of sterile drug product manufacturing. As therapies become more complex and patient safety expectations rise, regulators and standards-setting bodies are sharpening their focus on holistic contamination control strategies. When the European Union, World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised the GMP Annex 1 guidelines for sterile medicinal products, it raised the bar on expectations of manufacturers and their sterile product suppliers, by extension. Since the publication date, several other global jurisdictions have adopted these guidelines into their national law or developed complementary requirements.
In the complex world of pharmaceutical development, drug developers have a lot to think about. From formulation and testing to containment and delivery, every decision carries risk, cost, and long-term implications. Making these decisions can be overwhelming in and of itself — but when you consider that the timing of each choice can influence the overall drug timeline, the challenge intensifies. These complexities call for a forward-thinking approach — one that considers not just today’s choices, but the ripple effects they create across the entire drug product lifecycle.
That’s why it’s critical not just to make the right decisions for the moment, but the smart ones that enable a successful launch — and, more importantly, ensure the long-term success and sustainability of your drug product.
The RAPS Philadelphia Chapter, in collaboration with West Pharmaceutical Services, convened regulatory, quality, and industry professionals for a dynamic session focused on the implementation of the FDA’s Quality Management System Regulation (QMSR). Held at West’s Exton, PA facility, the evening provided a collaborative forum for industry professionals navigating the transition from the longstanding Quality System Regulation (QSR) to the newly aligned framework modeled on ISO 13485.
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