PAT; RTR; QbD; QRM – A gordian Knot?

• In: S6 - Implementation of Quality by Design and Risk Management- overcoming the practical hurdles on Thursday, 4 September 2008, 9:00-12:00
• At: Basel (Switzerland) (2008)
• Type: Presentation
• By: BARENDS, Dirk (RIVM, Bilthoven, Netherlands)
• Abstract:

  The concept of Process Analytical Technology (PAT) was originally proposed as a system of quality control based on in-process measurements instead of end product testing, making Real Time Release (RTR) possible, whereas Quality by Design (QbD) is more related to development pharmaceutics. Meanwhile, PAT is used in a broader sense, resulting in PAT

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