Category Archives: cGMP Quality Assurance and FDA 483s

FDA Sent These 3 Warning Letters for Pharma Companies | November 2017

We took a snapshot of the 3 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to have correct expiration dates to failing to investigate the unexplained.

From pharmaceuticals in China and India only, here they are (starting with the most recent):
Continue reading

Generic Drugs | A Guidance on FDA Guidance

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

On November 1, 2017, we published a blog that addressed a large collection of newly issued guidance for the generic drug industry.  With this post, we continue with another three generic drug guidance that were issued recently.  Consistent with the previous collection, many of these find their roots in GDUFA legislation.  This time we address three guidance documents.  Regulatory affairs departments should carefully read the first two that include detailed specifics on who needs to pay what and when.  The last guidance addressed here should be read carefully by groups who develop filing strategy.  It appears most problematic and may not provide the relief or speed as it may have intended.

Continue reading

Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas.  Let’s talk about activities in the GMP area.  Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be necessary in the manufacturing and testing of the firm’s products.  We provide five recent examples where the FDA appears to increase their enforcement intensity when an acquiring firm with perceived ‘deep-pockets’ enters the game.

Continue reading

FDA Sent These 6 Warning Letters for Pharma Companies | October 2017

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to prevent “mix-ups” to failing to adequately investigate.

From pharmaceuticals in Wisconsin, India, and more, here they are (starting with the most recent):
Continue reading

Recent Generic Drug Guidance

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

October has so far seen a flurry of guidance publications focused on generic drugs.  It’s unusual to see so many guidance on one kind of product published almost simultaneously — though the device area seems to be making the same effort!  Many of the generic drug guidance are published to implement requirements in the Generic Drug User Fee Act (GDUFA I or II).  Two of the guidance documents are final, and one is a MAPP; the others are drafts available for comments that the FDA will consider prior to finalizing.  In addition, the FDA published thirty-two (32) new draft bioequivalence guidance and nineteen (19) revised guidance to assist in the development of generic drugs.  We won’t cover the bioequivalence guidance here, but if you operate in the generics area, please look at them.  Let’s take each of the others in turn to briefly see what they cover.

Continue reading

FDA Sent These 5 Warning Letters for Pharma Companies | September 2017

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from sites failing to establish adequate quality control to failing to label products to bear adequate directions for use.

From pharmaceuticals in China, New Mexico, and more, here they are (starting with the most recent):
Continue reading

The Heightened Importance of Contract Manufacturing Organizations

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

One of the most thought-provoking presentations at the recent PDA / FDA meeting in Washington DC was given by Guy Villax, CEO of Hovione Pharmaceuticals.  Hovione Pharmaceuticals offers a range of contract services including but not limited to, product development, manufacturing of API and drug products, and analytical support.  Guy’s presentation was one of two on the opening day that addressed ‘Current Quality Challenges for Pharmaceutical Executives.’  He began his talk by saying that 60% of small molecule APIs for new NDAs are made by contract manufacturers.  I was surprised by the figure.  This is clearly different than practices of 15-20 years ago and, according to Guy, represent a migration of CMC knowledge to CDMOs.  That alone calls for us to re-evaluate the relationship between CDMO and sponsor firms, particularly for the virtual firms.

Continue reading

New FDA GMP Inspection Model

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted.  The FDA recently made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs.  This model continues the FDA’s efforts to refine inspection operations as described in their recent reorganization of the Office of Regulatory Affairs (ORA).   It aligns and supports the New Inspection Protocol Program.  The MRA between the EMA and FDA allows health authorities to maximize their abilities to focus inspection efforts on high risk sites and rely on each other’s inspection outcomes.  Taken together, these changes will permit:

Continue reading