European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift.

Pharmaceutical manufacturing 121

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 121

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 71

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 71

Pharmaceutical Technology

DECEMBER 14, 2022

Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA).

Food and Drug Administration 59

Food and Drug Administration Pharmaceutical products FDA Marketing 59

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation.

Pharmaceutical 91

Pharmaceutical Food and Drug Administration Transportation Manufacturing 91

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. What is the biggest impact of having compromised data when working with regulatory bodies in the pharmaceutical industry?

Government 83

Government Pharma Ethics Training 83

European Pharmaceutical Review

APRIL 21, 2023

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Giving environmental risk assessments teeth Since 2005, the authorisation of a human pharmaceutical product requires an environmental risk assessment (ERA).

Pharma 76

Pharma Food and Drug Administration Medicine Pharmaceutical 76

European Pharmaceutical Review

JANUARY 16, 2023

Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

Pharmaceutical 124

Pharmaceutical Food and Drug Administration Manufacturing FDA 124