Data integrity References of regularities

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FDA, Data Integrity and Compliance with CGMP Guidance for Industry Draft Guidance (CDER, April 2016).

2. MHRA, A GxP Data Integrity Definitions and Guidance for Industry, Draft version for consultation (MHRA, July 2016).

3. MHRA, GMP Data Integrity Definitions and Guidance for Industry (MHRA, March 2015).

4. WHO, Annex 5, Guidance on Good Data and Record Management Practices (WHO, June 2016).

5. PIC/S, Draft Guidance: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PIC/S, August 2016).

6. PDA, Elements of a Code of Conduct for Data Integrity (PDA, 2015).

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4 October 2019 at 21:08

Diazotization Titrations

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