Monthly Archives: February 2018


MONTHLY SCAN | February 2018

Lots of activity this month in guidance, non-guidance, and GMP enforcement. Happy reading!   Barbara FDA QUALITY:  Considerations for Applicants Deciding When to Submit Elemental Impurity Data to FDA QUALITY / CMC:  The FR announced the availability of a final revision 1 to their guidance, ‘Regulatory Classification of Pharmaceutical Co-Crystals.’   This finalizes draft guidance on the topic published [...]

By |2018-04-03T16:30:22+00:00February 28th, 2018|Monthly Scans|

WEEKLY SCAN | February 25, 2018

FDA published four guidance documents this week, two that address implementation of drug track and trace activities, and two that focus more on medical and safety.  The EMA published one item focused on inclusion of excipients in labeling. The non-guidance set of publications includes items from the EMA, FDA, MHRA, CDSCO, and TGA.  Under the non-guidance section, we also [...]

By |2018-04-03T16:31:47+00:00February 25th, 2018|Weekly Scans|

WEEKLY SCAN | February 18, 2018

FDA issued a collection of guidance this week regarding devices, safety, clinical ICH Quality and administrative items.  Also, WHO and TGA each published two new guidance each from. It was a busy week on the publication front. Enforcement included two warning letters, one to a device firm and one to an OTC drug product manufacturer.  Both are located outside [...]

By |2018-04-03T16:33:05+00:00February 18th, 2018|Weekly Scans|

WEEKLY SCAN | February 11, 2018

This week was slow in the publication of guidance documents.  FDA published three, and the EMA did not publish any in the areas we follow. Health Canada and HPRA each published one item.  We also include non-guidance documents and information published by EMA, MHRA, and FDA. Now, onto enforcement!   We include one warning letter issued to a device firm [...]

By |2018-04-03T16:34:35+00:00February 11th, 2018|Weekly Scans|

SPECIAL REPORT: FDA and MHRA Most Recent DFA Drug Inspection Observations

A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions, including FDA forms-483, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements and EU reports of GMDP noncompliance. This Special Report presents the most recent publications of GMP drug product inspection data from CDER and MHRA. The CDER data are from drug inspections conducted in FY2017, [...]

By |2018-04-01T21:15:13+00:00February 6th, 2018|Special Reports|

WEEKLY SCAN | February 4, 2018

A very slow week on the guidance front! FDA published two, EMA, TGA, Health Canada and WHO each published one.  Among the more interesting are is the GDP Inspection deficiencies from the MHRA for 2016, The FDA Office of the Generic Drugs annual report for 2017, and the EMA’s Eudra Vigilance Expert Working Group Programme for 2018. Enforcement actions this week included [...]

By |2018-04-03T16:36:07+00:00February 4th, 2018|Weekly Scans|