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cGMPs

Current Good Manufacturing Practice regulations (cGMPs) provide for systems that ensure proper design, monitoring, and control of manufacturing processes/facilities. Because deviations from cGMPs often result in 483s and warning letters from the FDA, it’s vital that pharma companies stay up to date on the latest changes in this area of their business.

Articles

Compliance fire drill: Mock FDA audits for cleaning validation

Pharma manufacturers should incorporate worst-case scenarios into assessment processes

Key considerations for CGMP raw materials compliance

It is never too early to consider CGMP requirements in pharma

Intas hit with FDA warning letter

The letter revealed that an analyst used acetic acid to destroy CGMP records

Beyond ‘good’ practices

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

Biocon hit with multiple 483s

Biocon, India's biggest biopharma, has revealed that the U.S. FDA has issued three Form 483s following inspections of the manufacturing facilities of its Biocon Biologics arm....

News

FDA hits Zydus with trio of observations

Aurobindo in trouble with the FDA again

FDA pauses facility inspections due to omicron variant

Novo Nordisk obesity drug faces supply challenges following CMO issues

Struggling Teligent Pharma recalls super potent lidocaine, again

Exclusive report says Novavax quality issues run deep

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

Pharma’s hybrid inspection model

Four strategic steps to creating and executing a hybrid audit protocol

Emergent BioSolutions: The path to re-emergence

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

Engineering Angles: Is your cold storage energy use through the roof?

How a commonly overlooked component of pharma facilities is impacting your bottom line

Quality woes thrust Emergent back in the spotlight

Earlier this week, new reports revealed that a production mistake at an Emergent BioSolutions facility contracted by Johnson & Johnson to make its COVID-19 vaccines lead to...

Fresenius Kabi pleads guilty to destroying records before FDA visit

Fresenius Kabi Oncology pleaded guilty to concealing and destroying records before a 2013 FDA inspection of its API manufacturing site in Kalyani, India

FDA issues countrywide import alert on Mexican hand sanitizers

Warning that hand sanitizer imported from Mexico could be tainted with dangerous chemicals, the U.S. FDA has issued its first-ever countrywide import alert for any category of...

Fresenius Kabi recalls sedative, again

Fresenius Kabi announced another voluntary recall of a single lot of injectable dexmedetomidine hydrochloride, due to cross-contamination with lidocaine.