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Manufacturing

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Industry Worries FDA Will See Drug GMP Violations Captured By Security Cameras

A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant inspections.

Compliance Manufacturing Quality
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Latest From Manufacturing

Best Practices Identified For Reducing Pharmaceutical Packaging Defects

An industry group has proposed some best practices for validating pharmaceutical packaging processes to minimize packaging defects. The paper is designed to fill a knowledge gap: while there is no shortage of information on how manufacturers can validate their manufacturing processes, less information is available on how manufacturers can validate packaging.

Manufacturing Quality

Biosimilar Post-Approval Change Guidance Coming From US FDA

Guidance, which is undergoing clearance, will address other products as well and might be released by the end of the year.

Manufacturing Biosimilars

Merck Cyberattack Recovery: Congress Scrutinizes Manufacturing Problems

A House committee has requested a briefing from Merck on the June 27 NotPetya malware attack that has impeded manufacturing operations, and on the pharmaceutical company's subsequent remediation efforts. Meanwhile, a pharmaceutical industry group is bringing experts together to brainstorm on cyber security best practices.

Cybersecurity Manufacturing

Hispanic Market OTCs Caught In Recalls Of PharmaTech-Made Drugs

FDA's Sept. 20 update to its recalls database includes listings for Doctor Manzanilla Allergy & Decongestant Relief and Cough & Cold oral solutions made by PharmaTech. Also recalled is a mis-labeled Medline Industries ointment.

Consumer Recalls

Turkey Finds Permanent Solution To Tamoxifen Shortage

The Turkish government plans to fix the country’s tamoxifen drug shortage problem by allowing by a local company to manufacture the product.

Market Access Pricing Debate

FDA Hits Two More Asian Firms With Drug GMP Warning Letters

The spate of recent warning letters going to foreign pharmaceutical manufacturers continues as two Asian firms get into trouble for GMP violations: Firson Co. in South Korea and Wuxi Medical Instrument Factory in China.

Manufacturing Quality
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