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About 800 results for "Fda Good Manufacturing Practices"

FDA hold on guidance for laboratory developed tests is a wise action
The Hill

What You Need To Know About the Food and Drug Administration R...

Start Preamble Food and Drug Administration, HHS. Notification of availability. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled What You Need To Know About the FDA ... Federal Register, 1 month ago

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Federal Register, 1 month ago

Wockhardt gets USFDA warning for violation of norms at UK facility

Wockhardt receives warning letter from USFDA for violation of good manufacturing practices at the facility of its indirect subsidiary, CP Pharmaceuticals, at Wrexham in the UK Mumbai: Wockhardt Ltd has received a warning letter from the US Food and ...
 Livemint.com2 weeks ago USFDA issues warning letter to Wockhardt's UK facility  Economic Times2 weeks ago USFDA raps Wockhardt on UK facility  Hindu Business Line2 weeks ago

AHPA Webinar Offers Expert cGMP Tips

The cGMPs (current good manufacturing practices) required for dietary supplement manufacturers, distributors and holders ( 21 CFR 111 ) consists of rules for cleaning, quality control, recording keeping and more, all of which can be overwhelming for ...
 Food Product Design1 week ago

GMP in Cleanroom Maintenance: Myths and Facts

Every cleanroom requires a carefully controlled environment maintained with Good Manufacturing Practices to prevent contamination By Omar Lopez, MBA, Pristine Environments Inc. Nov 12, 2016 In 2012, a fungal meningitis outbreak in the ...
 Pharmaceutical Manufacturing Magazine3 weeks ago

US FDA raises fresh concerns on Sun Pharma's Halol plant

The Halol plant is a key manufacturing unit for Sun Pharmaceutical, which earns about half its revenue from the US market The US Food and Drugs Administration (USFDA) has found deviations in goods manufacturing practices at Sun Pharmaceutical's ...
 Business Standard India2 hours ago Lupin's Goa plant gets nod from US FDA  Times of India1 month ago US FDA clears Lupin's Goa manufacturing facility  Livemint.com1 month ago US clean chit to Lupin plant  Calcutta Telegraph1 month ago

US FDA issues seven observations on Sun Pharma Mohali site

MUMBAI The US FDA recorded seven observations as part of its recent inspection of Sun Pharma's manufacturing site at Mohali. The site, which was earlier used to ship generic versions of popular cholesterol drug atorvastatin to the US, was brought ...
 Economic Times1 week ago
Federal Register

Metal deco inks with food contact compliance

A range of printing inks that are US Food and Drug Administration (FDA) and EU EFSA compliant for food contact are detailed in the latest brochure from the No-Tox Products Division of Colorcon Inc. The Pennsylvania-based firm says its expertise is ...
 Canmaker1 day ago Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability  Federal Register3 days ago Health Document Submission Requirements for Tobacco Products; Guidance for Industry; Availability  Federal Register3 days ago Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations  Federal Register4 days ago
Afternoon Despatch & Courier

State FDA issues show cause notice to Nashik firm for quality control violations

Maharashtra FDA has issued a show cause notice to a Nashik based firm for not complying to quality control protocols and good manufacturing practices. It was found during inspection that quality control officers were absent in the second and third ...
 PharmaBiz4 weeks ago Pharma unit gets show cause notice  Afternoon Despatch & Courier4 weeks ago

Superior Controls Announces Passing 50th Consecutive Biotech Supplier FDA-Required Quality Audit

., a leading control system integrator of custom industrial automation and IT solutions, today announced the company has successfully completed its 50th consecutive audit. For nearly two decades, Superior Controls has reliably delivered ...
 BioSpace1 day ago Validating the Software That Powers Your Manufacturing Systems and Automated Processes  FDA News6 days ago Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 510(k) Pre-IDE/IDE and PMA (Los Angeles, CA, United States - February 23-24, 2017) - Research and Markets  4 Traders3 weeks ago Two Day Writing and Enforcing Effective SOPs Course (Linthicum, MD, United States - April 6-7, 2017) - Research and Markets  Digital Journal5 days ago

FDA finalizes quality guidelines for contract manufacturers

The Food and Drug Administration has finalized guidelines, three-and-a-half years in the making, suggesting what should go into quality agreements between pharmaceutical companies and outsourced contract manufacturers. The agency's ...
 BioPharma Dive6 days ago Drugmakers Should Review Quality Agreements With Contractors, Attorney Says  Bloomberg BNA1 week ago FDA Issues Guidance for Quality Contracts Between Drugmakers  Bloomberg BNA1 week ago
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