Science & Technology

24
Jan

Investigations and Third Parties – Beware!

ICH Q10 (here) states the following as it relates to outsourcing activities and purchasing materials (hereafter referred to as third party): “The pharmaceutical quality system, including the management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately responsible to […]

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15
Dec

Devices to Head onto the Inspection Delay or Refusal Bandwagon

Since July 9, 2012, the day that the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 19 Law 112-144) was signed into law, drug products are deemed “adulterated for which a manufacturer processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or […]

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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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