Navigation For Mobile

Category Archives: Quality

What to Expect during Pharma Contract Manufacturing Project Onboarding

When your company decides to work with a CMO or CDMO on a drug API manufacturing project, the depth of the onboarding process dictates the success of the project. Onboarding…

Posted in Contract Manufacturing, outsourcing, Project Management, Quality | Tagged | Comments Off on What to Expect during Pharma Contract Manufacturing Project Onboarding

Improving Investigations: An Inspector’s Perspective

Facility inspections continue to be on the minds of both drug manufacturers and regulators. Over the past year, we’ve discussed the challenges surrounding inspections in our Maintaining Quality and Supply…

Posted in audit, CMC, COVID19, FDA, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , , , , | Comments Off on Improving Investigations: An Inspector’s Perspective

Europe Looks to Tighten Supply Chains

The last nine months have seen a complete re-evaluation of the risks inherent in global pharma supply chains. COVID-19 forced a doubletake in C-suites, but concern was already well on…

Posted in Quality, supply chain | Tagged , , , , , , | Comments Off on Europe Looks to Tighten Supply Chains

Nitrosamines – A Timeline

Here’s an infographic detailing some of the history of nitroso compound contaminants. Nitrosamine, a probable human carcinogen, continues to make the news as the FDA, EMA and other regulatory agencies…

Posted in genotoxic impurities, Quality | Tagged , , , | Comments Off on Nitrosamines – A Timeline

Update on Regulatory Guidance for Facility Inspections

During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…

Posted in APIs, audit, Chemistry, CMC, COVID19, CRO/CMO, FDA, Industry news, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , | Comments Off on Update on Regulatory Guidance for Facility Inspections

The Impact of Impurities on the Pharmaceutical Industry

A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…

Posted in API synthesis, APIs, Chemistry, drugs, genotoxic impurities, Impurity profile, QA/QC, Quality, Route Design, Route Scouting, synthesis, Synthesis Route, Valsartan | Comments Off on The Impact of Impurities on the Pharmaceutical Industry

Looking for an API Supplier? 5 Things to Consider (Updated)

Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, drugs, FDA, Neuland Labs, process chemistry, Process Engineering, Project Management, Quality, R&D, regulatory, supply chain, synthesis | Tagged , , | Comments Off on Looking for an API Supplier? 5 Things to Consider (Updated)

Video: Pharmaceutical Analytical Capabilities & Drug Quality

Drug quality and strong analytical capabilities go hand-in-hand. It is virtually impossible to achieve the former without the latter at all stages of a drug’s development and production.

Posted in API synthesis, APIs, Chemistry, chromatography, drugs, QA/QC, Quality | Tagged , , , | Comments Off on Video: Pharmaceutical Analytical Capabilities & Drug Quality

On-Site Pharma Audits During the Coronavirus (COVID-19) Crisis

The outbreak of COVID-19 has significantly impacted physical visits to drug manufacturing facilities. This raises a number of challenges, since many regulations — especially those relating to inspections — weren’t written with…

Posted in APIs, CMC, drugs, FDA, Quality, regulatory | Tagged , , , , | Comments Off on On-Site Pharma Audits During the Coronavirus (COVID-19) Crisis

Nitrosamine Impurities and How Companies are Addressing the Crisis

We’ve recently written extensively about nitrosamine impurities, including this in-depth analysis of what transpired with Valsartan, and some follow-up material, here and here. Nitrosamine impurities have been receiving a great…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, genotoxic impurities, Quality, Valsartan | Tagged , , , , , | Comments Off on Nitrosamine Impurities and How Companies are Addressing the Crisis