Remove Headlines Ingredients
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Industry examining FDA guidance on nitrosamines

Quality Matters

Earlier this spring, the FDA requested further stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and active pharmaceutical ingredients (APIs), and USP was one of numerous organizations that submitted comments to the agency.

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How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

pharmaphorum

Supply chain shortages have dominated headlines for several months, and the pharma industry has been no exception. Businesses are facing challenges in obtaining raw ingredients for medicines. With many ingredients shipped in from offshore, businesses need to consider logistics. The stakes are high. Logistical challenges.

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Part One: Industry examining FDA guidance on nitrosamines

Quality Matters

Earlier this spring, the FDA requested further stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and active pharmaceutical ingredients (APIs), and USP was one of numerous organizations that submitted comments to the agency.

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The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

In the absence of extensive available information on the toxicity of common formulation ingredients, ie, excipients, EG was used as a vehicle (72 percent w/v) in the formulation. DEG from impurities in ingredients like glycerine and polyethylene glycols in finished cosmetic products can be considered to be safe”.

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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

Pharmaceutical companies regularly outsource different steps of drug manufacturing processes like parenteral manufacturing and packaging, solid dose, and small molecule or biologic active pharmaceutical ingredient (API) production, among others. Covid-19 vaccines stay in the spotlight.

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Standards on the Frontlines: Responding to public health crises and strengthening supply chains

Quality Matters

Standards on the Frontlines: Responding to public health crises and strengthening supply chains Vulnerabilities or disruptions to the global medicine supply chain (including drug shortages) continue to make headlines. Ingredient testing by manufacturers can be used to successfully detect the presence of DEG, EG, and other poisons.

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Standards support medicines supply chain resilience and the future of quality

Quality Matters

Examples include standards for both active and inactive pharmaceutical ingredients (excipients), distribution standards covering temperature excursions, and labeling standards that support health literacy. We also see complex generics that can have a complex active ingredient, formulation, route of delivery or device component.