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Manufacturing

Set Alert for Manufacturing

Woodcock: The US FDA Sets The Stage For Global Quality Dossiers

New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.

Manufacturing Quality Drug Approval Standards

Generic Industry Not Sold On Benefits Of FDA Emerging Technology Program

FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.

Manufacturing Quality BioPharmaceutical

Latest From Manufacturing

New AMR Report Is ‘A Wake-Up Call’, Says Industry Body

Another day, another report on how to tackle the ever-present problem of antimicrobial resistance and the dearth of new treatment. In its latest assessment of the state of play, the AMR Industry Alliance has come up with some alarming facts and figures – and some ideas for the next steps.

International Manufacturing

New Jersey OTC Firm Lacked GMP Basics, FDA Warning Letter Says

US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.

Manufacturing Quality

India 2019 – R&D Highs, Compliance Woes And Other Lows

2019 saw Indian companies advance innovation efforts and build and expand their specialty portfolios and biosimilars businesses. But manufacturing compliance issues weighed down several firms while on another front charges against the Singh brothers of Ranbaxy escalated.

India Regulation

EU Says Nitrosamine Risk Info Also Needed For New Drug Filings

Companies seeking approval of new drugs must provide information on nitrosamine-related risk evaluation either as part of their marketing application or during the evaluation process.

Manufacturing Regulation

Removal Of ‘Legal’ And ‘Implicit’ Terms Cleared Way For ICH Q12 Guideline

Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.

Manufacturing Quality

Switzerland, South Korea Sign Deal On Recognizing GMP Inspections

Agreement will help save inspection resources at Swissmedic and South Korea’s Ministry of Food and Drug Safety.

Switzerland South Korea
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