Navigation For Mobile

Archives

Improving Investigations: An Inspector’s Perspective

Facility inspections continue to be on the minds of both drug manufacturers and regulators. Over the past year, we’ve discussed the challenges surrounding inspections in our Maintaining Quality and Supply…

Posted in audit, CMC, COVID19, FDA, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , , , , | Comments Off on Improving Investigations: An Inspector’s Perspective

Process Validation: Maintaining Quality Consistency

The basic principle of pharmaceutical quality assurance is that a drug should be safe and effective for its intended use – and process validation plays a pivotal role in ensuring…

Posted in APIs, Chemistry, process chemistry, Process Engineering, QA/QC | Tagged , , , | Comments Off on Process Validation: Maintaining Quality Consistency

What the Revised FDA CDER SSM Really Means

Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…

Posted in API synthesis, APIs, audit, FDA, outsourcing, Quality, regulatory, supply chain | Tagged , , , , | Comments Off on What the Revised FDA CDER SSM Really Means

Non-Cytotoxic Drug Compounds & India’s GMP Schedule M

Drug product volumes have been shrinking as increasingly niche products emerge to treat various conditions. Coupled with the rise of pharmaceutical manufacturing outsourcing, this has led to a reconsideration of…

Posted in APIs, Chemistry, Contract Manufacturing, cytotoxic, drugs, FDA, Neuland Labs, oncology, regulatory, Schedule M | Tagged , , , , | Comments Off on Non-Cytotoxic Drug Compounds & India’s GMP Schedule M