As you will all be aware, EU GMP Volume 4 Annex 1 and PIC/S Annex 1 (hereinafter referred to Annex 1) for “the manufacture of sterile medicinal products” was published in August 2022 and the majority of the guidance came into force in August 2023. One of the key elements of the guidance was the introduction of Quality […]
Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]
April Fool’s Day was a difficult day for many FDA employees, because that was when many of them found out they were let go as they attempted to enter FDA’s White Oak HQ by swiping their badges at the entry gates. With many significant Offices and Division cuts, there are questions of how those cuts […]
The recent bankruptcy announcement of 23andMe is a classic case study in data ownership – not necessarily what should happen, but what actually does happen! Open and transparent discussion about data ownership is sometimes easier if the situation is not strictly a GxP issue, but the learnings and analogies in a QMS or PQS should […]
In April 2018, whilst I was still an expert Inspector at the MHRA, I wrote a blog on vapour hydrogen peroxide. Having recently joined Lachman Consultants, I thought it would be an ideal time to revisit this subject to understand the current situation with this method and perhaps provide insight as to what Lachman could […]
On October 26, 2020, a business plan was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that eventually resulted in a holistic revision to ICH Q9, “Quality Risk Management,” the “R1” of the framework. The four areas of concern were identified as: High levels of subjectivity in risk assessments […]
In today’s rapidly evolving technological landscape, pharma and biotech businesses are increasingly looking to leverage artificial intelligence (AI) to gain a competitive edge. However, before diving headfirst into AI, it is crucial to lay a solid foundation. One of the most effective ways to do this is by implementing a Unified Namespace (UNS). This blog […]
Last week, I had the privilege of attending The Indian Pharmaceutical Alliance’s 10th Global Pharmaceutical Quality Summit in Mumbai. Not only was the event loaded with excellent content presented by leaders of the generics industry, it also provided invaluable chances to discuss innovation and opportunities for the industry with individuals in quality from around the […]
Since 1976, the International GMP Conference has been co-sponsored by the University of Georgia College of Pharmacy and the U.S. Food & Drug Administration. However, this year, through no fault of the Agency, the FDA was unable to attend. This was unfortunate (to say the least), especially as this public-private collaboration amongst a number of […]
There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]
