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Pharmaceutical Manufacturing and Packing Sourcer
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Given how vital the practice is to international regulatory compliance and to keeping products safely on the market, it may be expected that global life sciences firms would have the production and management of patient-facing materials efficiently coordinated so that accuracy and speed to market were taken for granted. Nothing could be further from reality.
Undoubtedly, the global labelling management burden in life sciences has soared in recent years. Companies’ R&D ambitions are growing, businesses are expanding into more markets, and regulators are steadily strengthening safety requirements to protect patients from harm. Each time the benefit/risk profile or safety factors change, or as regional or local regulatory agencies update their standards, international biopharmaceutical firms must react swiftly with accurate, compliant labelling for all affected markets. If they fail to do so, they risk delays to shipping or even to keeping their product registrations on the market, with implications for sales, revenues, and reputation.
Given that all of these market conditions are set to intensify rather than diminish, finding a solution sooner is now a priority. Balancing market opportunity, risk, and cost is becoming increasingly tough to do, so it is unsurprising that organisations are keen to bring the situation under control. As the frequency of changes increases − due to ever-growing product complexity, heightened pharmacovigilance, and new regulatory specifications – the demand soars exponentially.
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News and Press Releases |
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Neopac’s Polyfoil MMB® Tube Approved by USA’s Association of Plastic Recyclers
Oberdiessbach, Switzerland – Hoffmann Neopac, a global provider
of high-quality packaging for pharma, beauty and oral care, has been
granted approval for its Polyfoil® MMB mono-material barrier tube by the
US-based Association of Plastic Recyclers. Offering a groundbreaking
combination of product protection, user friendliness and appealing
aesthetics, the tubes passed muster both with and without its thin film
metallization option.
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White Papers |
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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events |
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Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022)
20-21 June 2022, Berlin, Germany
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) is
held on June, 20-21, 2022 in Berlin, Germany. The Congress gathers
pharmaceutical companies, CMOs and CDMOs, governmental bodies together
with pharmaceutical equipment providers and service companies to discuss
the manufacturing and packaging processes of the pharmaceutical
industry. Among the participating companies are Bayer, Sandoz, Merck,
Novartis, Roche, Genveon, Samsung Biologics, Pfizer.
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