European Pharmaceutical Review

AUGUST 23, 2022

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.

FDA 105

FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 105

European Pharmaceutical Review

AUGUST 25, 2023

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?

Manufacturing 98

Manufacturing Pharmaceutical manufacturing Pharmaceutical Training 98

European Pharmaceutical Review

JULY 18, 2023

Most of the quality management systems providers are focusing on capturing these large pharmaceutical markets. Also noted in the report was the shift towards cloud-based systems.

Marketing 98

Marketing Management Manufacturing Pharmaceutical manufacturing 98

pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. Companies could benefit from talking to third party experts such as NSF to ensure that they are in compliance.

Pharma 97

Pharma FDA Consulting Manufacturing 97

pharmaphorum

OCTOBER 27, 2022

To help limit company responsibility for employee actions, companies should provide training to employees, relevant to their role, regarding appropriate conduct on social media. The rationale for engaging with certain influencers and digital opinion leaders should be considered and documented.

Media 86

Media Pharmaceutical Medicine Electronics 86

PM360

MAY 21, 2024

It’s a powerful technology that, if used correctly, can help us all reach new heights in pharmaceutical manufacturing and beyond. It’s easy to get excited about using AI to solve problems, but doing so without proper training has the potential to cause more of its own. It’s a fascinating exercise to ask AI to define these areas.

Manufacturing 52

Manufacturing Pharma Education Pharmaceutical manufacturing 52