OOS: Whose Line is it Anyway? The Contract Testing Laboratory’s or Sponsor’s?

When it comes to investigating OOS results, a clear line should be drawn between the responsibilities of a contract testing laboratory (CTL) and that of the manufacturer/sponsor. Before we come to the testing part, here are some questions (not all inclusive) to be asked by your firm before selecting a CTL for outsourced testing: (1) […]

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Highlights from the Recent European Biomanufacturing Summit

The European Biomanufacturing Summit was held on May 31 and June 1, 2023, and was attended by industry leaders from multinational biotech and biologics companies, largely from Europe. The agenda on the first day of the conference included topics related to modernization and digitization of the pharmaceutical industry.  The presenters talked about challenges in transforming […]

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Analytical Method Validation, Verification, or Qualification – What to use and when?

Analytical development and/or QC groups at early-stage pharmaceuticals and biopharmaceuticals often ask themselves about the level of level of confirmation of suitability required for their methods. Often the term ‘validation’ is used without understanding the full implications of the term. Sometimes, the terms validation, qualification and verification are used interchangeably. While ‘validation’ is well understood […]

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To Average or Not to Average, That is the Question?

Earlier this year, we posted about FDA’s new revision for the OOS Guidance for Industry.  The new revision allows ‘averaging’ results from a pool of replicate results even though one of them is OOS for ‘certain circumstances.’  This was the most significant change in this revision.  So the question is, can you always average?  If […]

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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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