Compliance

Articles

Compliance fire drill: Mock FDA audits for cleaning validation

Pharma manufacturers should incorporate worst-case scenarios into assessment processes

Anticipating AI regulations in pharma manufacturing

In a rapidly evolving regulatory landscape, leaders should remain ready to adapt to new legislation

2024 pharma predictions: Regulations, sustainability and culture

In part 2 of our series, leaders weigh in on what the pharma industry can expect in the coming year

Key considerations for CGMP raw materials compliance

It is never too early to consider CGMP requirements in pharma

Beating FDA to the punch

A proactive approach to risk mitigation can help weed out quality issues before they become citations

News

Intas hit with FDA warning letter

Biocon hit with multiple 483s

Ocugen could face $10,000 FDA non-compliance fine

FDA shares gene therapy research guidance

FDA hits Zydus with trio of observations

Aurobindo in trouble with the FDA again

Beyond ‘good’ practices

Pharma quality regulation has evolved beyond routine CGMP compliance toward a more holistic, proactive approach

Developing a cell and gene therapy packaging strategy

Optimal packaging and labeling solutions help ensure the delivery of safe, effective viral vector products

Toward a collaborative pharma ecosystem

A new biomanufacturing era demands that suppliers and manufacturers partner to efficiently bring new therapies to market

Getting drug quality right the first time

CAPA remains an integral element of cost-effective quality management in pharma

Supporting continued process verification

CPV is required for regulatory compliance but can also provide process improvements

Juggling the regulatory complexities of global clinical trials

Deploying an automated process can help simplify safety and compliance information

Pharma’s hybrid inspection model

Four strategic steps to creating and executing a hybrid audit protocol

FDA year in review: 50 novel drug approvals and more

First-in-class and orphan drugs dominated the agency's 2021 approvals

Emergent BioSolutions: The path to re-emergence

How the Bayview plant put itself — and pandemic preparedness — on a better course

FDA pauses facility inspections due to omicron variant

The U.S. FDA has put certain inspectional activities on hold through Jan. 19 in response to the rapid spread of the omicron variant of COVID-19.