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) […]
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 […]
Have you ever wondered why, in many airports across different countries, there are multiple random security checks after the initial check at the entrance and before boarding the plane? Do all these intermediate checks make flying much safer? Are intermediate checks required because the initial check may not be trustworthy, or are they intended to […]
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 […]
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 […]
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 […]
