How to Apply DQ/IQ/OQ/PQ in New Framework
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How to Apply DQ/IQ/OQ/PQ in New Framework This paper explains what European Annex 15 covers (excluding Cleaning Validation that is covered in other papers) and how it links to modern…

Design of an Efficient Stability Programme -Bracketing and Matrixing
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Design of an Efficient Stability Programme -Bracketing and Matrixing WHAT GUIDELINES EXIST? We will focus mostly on the following guideline: Q1D Bracketing and Matrixing Designs for Stability Testing of …

QP Declaration
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QP Declaration Overview History Behind the QP Declaration The GMP Compliance Audit of the active substance Manufacturer The Importance of the Technical Agreement (Contract) QP Declaration – template QP pedigree…

Negotiations on Cost and Availability of New Pharmaceuticals
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OECD countries are now facing a rising number of new medicines offered at high prices which challenged health authorities and health care payers to secure access for patients to new, life-saving treatments…

Covid-19 in China - Statistics & Facts
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At the beginning of December 2019, China has confirmed that they have been treating the first cases that were identified from patients with severe pneumonia in the hospitals in Wuhan, China.…

5 Health Care Stocks to Bet on as Coronavirus Woes Linger
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In the midst of finding a cure for coronavirus vaccine, some sectors of the health care industry are actually making substantial progress. The health care industry has been mostly outperforming …

Coronavirus Impact on the Tourism Industry Worldwide
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The world is currently experiencing a pandemic of an infectious disease called coronavirus disease 2019 or mostly known as COVID-19.…

Cold chain distribution; route qualification approaches
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Good Distribution Practices (GDPs) state that temperature-sensitive goods need to be distributed (stored, treated and transported) through the distribution network (manufacturers, service providers and customers)…

The v model in validation
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Requirements verification and validation is a vital aspect of applications and software engineering. The significance of verifying and validating (especially testing) is a significant reason why a minor …

GAMP V computer system validation
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GAMP – Founded in 1991, Good Automated Production Practices is a trademark of the International Society of Pharmaceutical Engineering (ISPE). GAMP-V was introduced in 2008 …

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