FDAzilla GMP Regulatory Intelligence Newsletter

FDAzilla GMP Regulatory Intelligence Newsletter
FDAzilla GMP Regulatory Intelligence Newsletter2019-01-24T16:12:39+00:00

Latest Issue

WEEKLY SCAN | October 6, 2019

Three guidance documents from FDA, one from EMA and one each from Malaysia and ICH.  The non-guidance area has some valuable items including an Excel spreadsheet from MHRA identifying GMP deficiencies in the second bullet point under MHRA.  MHRA continues to publish revisions / guidance should a no-deal Brexit become a reality at the end of October. Enforcement has lots of coverage this week.  Only one warning letter to a fertility clinic but two announced warning letters that FDA [...]

By |October 15th, 2019|Categories: Weekly Scans|0 Comments

Special Reports

May 22nd, 2019|0 Comments

An evaluation of warning letters associated with data governance and data integrity deficiencies. In this summary, we identify: • [...]

January 22nd, 2019|0 Comments

A detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends [...]

January 8th, 2019|0 Comments

RISK FACTORS USED IN SCHEDULING FDA DRUG GMP INSPECTIONS The global supply chain for drug products sold in the [...]

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