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…

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