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Stability Testing and Forced Degradation Stress Tests - Proactive Risk Management

Whereas the durability of many consumables, have a strong tendency to decrease, stability is and remains a crucial factor for pharmaceuticals. That is why the identification and elimination of factors, which put long-term stability at risk, is central during development – and an important requirement concerning the product’s quality.
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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market

PCI Pharma Services

Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets (1). It discovered the product was shipped by sea from India to multiple companies in the UK at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used.
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World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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