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Quality & Compliance

Manufacture Process Control

The Human Cost of Poor Practice

| Rob Coker | 2 min read

A growing number of deaths linked to pediatric medicines prompts the WHO to investigate “unacceptable” levels of APIs.

Manufacture Packaging

Getting to Grips with the E&L Threshold

| Stephanie Sutton | 8 min read

The PQRI has released new recommendations on E&Ls in parenterals.

Manufacture Packaging

Chill Out: Understanding the Realities of mRNA Therapeutic Storage

| Silvia Gallina, Marco Povolo | 4 min read

As we transition into the endemic phase of the pandemic, companies will have to consider how their mRNA products will be housed and stored.

Business & Regulation Standards & Regulation

How to Avoid FDA Warning Letters

| Stephanie Sutton | 3 min read

It’s relatively simple: Follow cGMP, keep your facilities clean, keep vermin out, and don’t sell unapproved products…

Business & Regulation COVID-19

VIDEO: From Quality Control to Cold Chain

| Sponsored by Dätwyler

The world wasn’t ready for COVID-19. But if we learn the right lessons, next time next time we’ll do better.

Manufacture Facilities

Don’t Worry, Be HPAPI

| Angus Stewart

We dig into the story of Lonza in China, and its new HPAPI expansion in Guangzhou

Discovery & Development Analytical Science

Meet the Trendsetting Techniques of Biotherapeutic Molecule Characterization

| Eliza Lee

Advanced analytical technologies now offer the detailed assessments biopharma drug developers need.

Business & Regulation Standards & Regulation

Sharing is Caring (for Animals)

| Stephanie Sutton

How an initiative from EFPIA and a new public database on chemical substances could reduce animal experiments.

Manufacture Facilities

Embracing the Quality Mindset

| Mike Martin

With the FDA still behind on inspections, manufacturers need to uncover their own blindspots.

Business & Regulation Standards & Regulation

The (DILI) Model of Success

| Maryam Mahdi

An industry consortium is tackling one of pharma’s biggest drug-related challenges.


Latest White Papers

Overcoming the challenges of nitrosamine impurities in drugs

| Contributed by Thermo Fisher Scientific

HRAM LC-MS method for the determination of nitrosamine impurities in drugs

| Contributed by Thermo Fisher Scientific

LC-MS/MS method for the quantification of 10 nitrosamine impurities in metformin

| Contributed by Thermo Fisher Scientific

All White Papers

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