Science & Technology

01
Jul

Continuous Manufacturing vs. Batch Manufacturing – Where Will the Industry Go?

In a recently released publication on the FDA website entitled, An FDA Self-Audit of Continuous Manufacturing for Drug Products (here) the FDA relayed its experience with some quantified data and some estimates of savings from the use of the continuous manufacturing (CM) vs. batch manufacturing (BM) albeit, from a limited number of applications. Key take […]

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23
Jun

Beta‑Lactam Antibiotics 2013 Guidance for Preventing Cross Contamination Hits the Street

The focus on beta‑lactam antibiotics has primarily concentrated on penicillin and its derivatives because of the issue of severe allergy or anaphylaxis that can occur in individuals with sensitivities to these products.  Over the years, as more and more non‑beta‑lactam antibiotics were introduced to the market, there has also been growing concern that these new […]

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14
Jun
Young man looks at road map near on mountain road, Switzerland

To Measure or Not to Measure, Quality Metrics Is the Question!

The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion.  People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation.  Thus, quality metrics were held tightly close to the chest of business leaders.  Deming identified this […]

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25
May

Revision of OOS Results Guidance Provides Current FDA Thinking and Expectations

In today’s blog, we want to create awareness that, after sixteen years, in May of 2022, the FDA has finally announced revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. (here). Specifically, this revision updates terminology for consistency with current FDA guidance, e.g., the quality control unit “QCU” is changed to the […]

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16
May

The Significance of Data Invalidation

When reviewing health agency citations, investigators are naturally concerned when observing cases of data invalidation during investigations and may well question the motives/justification accordingly. This can lead to some uncomfortable exchanges between firms and health agencies! So how should a laboratory protect themselves from such a situation? First, you want to ensure that, per your […]

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11
May

The Battle of Harmonization Continues! It Takes Time – Day 2

Tuesday’s session of the Fiscal Year (FY) 2022 Generic Drug Science and Research Initiatives Public Workshop opened with a presentation by Michael Banks, Senior Vice President, Global Head Regulatory Affairs, Teva Pharmaceuticals discussing the global challenges to the development of complex generic drugs.  Dr. Banks challenged the regulatory bodies to move towards more standardized approaches […]

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10
May

Lots of Questions and Lots of Industry Advice in Research Initiatives Workshop Day 1

The FY 2022 Generic Drug Science and Research Initiatives Public Workshop held May 9-10, 2022, addressed a significant number of complex drug product questions as well as feedback from the industry as to what steps would be helpful for FDA to undertake to facilitate complex product development, review, and approval.  With GDUFA III considered to […]

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06
May

Hold On! That Previously Acceptable Level of Nitrosamine in Your Product is No Longer Acceptable!

Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read:  “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]

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28
Apr

The Future of Us

As our world spins toward the highly anticipated “new normal,” pharma and related industry conferences in the last few months have shown us that the new normal will be anything but business as usual.  Instead, we are witnessing an accelerated adoption of advanced new technologies that many of us had previously associated with the IT […]

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19
Apr
Continuous Manufacturing and its Regulatory Challenge Image

Particles, Particles, Particles – Some Have a Game Plan

During day 2 of the PDA conference, there was a very enlightening session called “Game Plan: Progress to the Next Stage of Contamination Control.”  Anne Marie Dixon-Heathman, President of Cleanroom Management Associates, Inc., gave a presentation called “Contamination Control: A new approach to the Reduction of 5-micron particles.”  She discussed product loss resulting from five-micron […]

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