Displaying 1–25 of 290 results for cGMPs
Exploring best-practice manufacturing strategies for highly potent oral solid dosage forms
In pharma plants, age definitely matters.
A mix of the biggest hits from 2018
Atrium improves audits and complaints, change control, and product release processes with immediate access to information and operational visibility
While the field of stem cell therapy has been in development for decades, regenerative medicine is now experiencing rapid progress fueled by scientific and technology advancements.
Changes stemming from regulations, technological innovation and discovery bring about challenges for brand owners, packagers and OEMs
In FDA’s world, ET does not refer to The Extra-Terrestrial as made famous by the movie, but rather Emerging Technologies, and it set up a special task force to facilitate pharmaceutical innovation
Are your pallet choices aiding or thwarting your facility’s sanitation efforts?
Validation, calibration and qualification are extremely critical in pharmaceutical processes. Understanding them is necessary in order to meet cGMP guidelines.
Hyderabad-based API provider Neuland Labs sheds the stigma of Indian manufacturers by building stringent quality control into every process
Are the risks of leveraging this new technology outweighing the benefits for drug makers?
Industry standards help guide process instrument selection in pharmaceutical and biotech manufacturing environments, but further judgment is often required
The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology
Continuous manufacturing, and the advanced process control tools that support it, play a key role in future development for smart manufacturing
Design & implementation of a compliance process with global governance: a case study
What can a PAT program bring to the packaging party?
Ending the up-hill battle of Paper-based validation document control
Patent-pending baffle design gives the mixing performance of a stainless steel bioreactor with no cleaning required
Pharmaceutical processors have begun to wield some new tools, nailing down new efficiencies and better drugs in the process
There’s far more to becoming a paperless lab than simply eschewing paper. An integrated informatics solution is the engine that drives quality product release and a culture of continual process improvement.
FDA has released final guidance detailing the types of actions, inaction, and circumstances that the FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection.
Significant factors contributing to uncertainty in the healthcare supply chain are more stringent regulations and increased product protection challenges
OEMs must comply with additional regulatory requirements
Pharma’s tech bench gets deeper with an All-Star lineup ready for the big leagues
Complexity and lean staff often create a non-compliant operational culture; fortunately there are ways to fight the malaise