Displaying 1–25 of 290 results for cGMPs

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Today's solid dose drugs: High potency, high stakes

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Exploring best-practice manufacturing strategies for highly potent oral solid dosage forms

Still got it: Tips and tricks to keep your older pharma plants riding high

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In pharma plants, age definitely matters.

Regulatory Rewind

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A mix of the biggest hits from 2018

Atrium Innovations Modernizes Quality Management

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Atrium improves audits and complaints, change control, and product release processes with immediate access to information and operational visibility

Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory ...

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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.

State of Packaging in the Pharma Industry

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Changes stemming from regulations, technological innovation and discovery bring about challenges for brand owners, packagers and OEMs

ET Phone Home, Then Call the FDA

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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

Pallet Type Matters

(Article)

Are your pallet choices aiding or thwarting your facility’s sanitation efforts?

Validation & Qualification in Pharma Facilities

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Validation, calibration and qualification are extremely critical in pharmaceutical processes. Understanding them is necessary in order to meet cGMP guidelines.

No-Compromise APIs

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Hyderabad-based API provider Neuland Labs sheds the stigma of Indian manufacturers by building stringent quality control into every process

Three Big Risks in 3D Printing Pharmaceuticals

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Are the risks of leveraging this new technology outweighing the benefits for drug makers?

Specifying Instruments to Meet Pharmaceutical Hygienic Requirements

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Industry standards help guide process instrument selection in pharmaceutical and biotech manufacturing environments, but further judgment is often required

'Future-proofing' Serialization Solutions

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The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology

Smart Manufacturing, FDA’s Vision for Quality

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Continuous manufacturing, and the advanced process control tools that support it, play a key role in future development for smart manufacturing

Paving the Road for Sustainable Solutions

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Design & implementation of a compliance process with global governance: a case study

The Forgotten Segment in PAT

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What can a PAT program bring to the packaging party?

Why Are Paper Mountains Still Common in Validation?

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Ending the up-hill battle of Paper-based validation document control

Mobius 2000 Liter Single-Use Bioreactor

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Patent-pending baffle design gives the mixing performance of a stainless steel bioreactor with no cleaning required

Pharmaceutical Tools of the Trade

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Pharmaceutical processors have begun to wield some new tools, nailing down new efficiencies and better drugs in the process

QA/QC Labs and Smart Infrastructure Equal End-to-End Quality by Design

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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.

Final FDA Guidance: What Constitutes a Delayed or Refused Drug Inspection?

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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.

Health Care Reveals its Supply Chain Pain

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Significant factors contributing to uncertainty in the healthcare supply chain are more stringent regulations and increased product protection challenges

Supply Chain Security Breaches Increase Regulatory Scrutiny, Says Dow Corning

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OEMs must comply with additional regulatory requirements

All-Star Innovators 2014

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Pharma’s tech bench gets deeper with an All-Star lineup ready for the big leagues

Pursuing Solid-Dose-Processing Quality

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Complexity and lean staff often create a non-compliant operational culture; fortunately there are ways to fight the malaise

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