Science & Technology

29
Sep

Validation Still the Key to Success

The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop.  The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from […]

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28
Sep
Quality Agreements Image

Great Quality and Great Business Is Interdependence in Plain Sight?

If our supply chain was weak prior to the pandemic, this global event accelerated its failure.  These signals of weakness were laid bare during the pandemic  and identified in publications such as the 2019 report “Drug Shortages:  Root Causes and potential Solutions” (here).  Prior to the Covid PHE, focus on shortages was placed much more […]

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15
Sep

Changes Forced Upon FDA and Industry Highlighted at PDA FDA Joint Regulatory Conference

At the first in person PDA/FDA Joint Regulatory Conference since the pandemic began, (held September 12-14 in Washington, DC), it was almost impossible to escape the effect that the pandemic had on everyone attending the meeting, regardless of their affiliation. From the inevitable exclamation from presenters at the podium about how great it was to […]

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30
Aug

“GMP By the Sea” Reflections

In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD.  A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a […]

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19
Jul

Is It Time to Revisit USP <1058>?

With the issuance of draft ICH Quality Guideline ICH Q14 on Analytical Procedure Development (here) and revision of ICH Q2(R2) Guideline on Validation of Analytical Procedures (here), along with the issuance of USP <1220> Analytical Procedure Lifecycle, perhaps it may be time to revisit USP <1058> Analytical Instrument Qualification (AIQ). USP <1058> is a critical chapter providing key guidance on […]

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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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