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About 805 results for "Fda Good Manufacturing Practices"

Maintaining data accuracy and integrity in the manufacturing industry

FDA Releases Q7 GMP for API Guidance

The guidance addresses the good manufacturing practice for managing quality in APIs. On Sept. 29, 2016, FDA published the revised Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry . The guidance ... BioPharm International, 1 day ago
What's New with the FDA's Data Integrity Guidance? Spectroscopy Magazine Online, 1 day ago

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FDA Says No To Nicox, Lundbeck's Persistence Pays Off, It's A Win For LPCN

In its Complete Response Letter, the FDA has cited solely the Good Manufacturing Practice at third party active pharmaceutical ingredient supplier facility as the reason for not approving AC-170. The regulatory agency's decision on AC-170 was ...
 Nasdaq1 week ago Trouble at Nicox cetirizine facility prompts FDA response letter and dela  FiercePharma1 week ago FDA hits Nicox with CRL on eye drug application  BioPharma Dive1 week ago Aptose receives FDA request for APTO-253 CMC info  Stockwatch1 week ago
Federal Register

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles

Start Preamble Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction ...
 Federal Register1 week ago

Cipla gets 4 observations from US FDA for its three plants in Goa

The US FDA has been issuing Form 483 observations and warning letters to Indian drug makers for failing to meet good manufacturing practice standards laid down by it Hyderabad: Drug maker Cipla Ltd on Friday informed stock exchanges that said it got ...
 Livemint.com3 weeks ago Cipla's Indore factory gets US FDA clearance  Livemint.com1 week ago

Wockhardt slumps 10%

The US Food and Drugs Administration (FDA) issued an import alert on Ankleshwar plant for alleged violation of good manufacturing practices, says report.
 India Infoline2 months ago Wockhardt falls 14 pct on import alert; Macquarie downgrades  Business Standard2 months ago Wockhardt gets import alert from US FDA  Rediff.com2 months ago Wockhardt shares up on exclusion of antibiotic by USFDA from import ban  Livemint.com2 weeks ago

The importance of key quality systems for GMP implementation

Dr Kishore Motwani explains to Animal Pharm how some good manufacturing practices (GMPs) have been the result of tragedy. He also highlights the importance of GMPs to the veterinary medicines industry. It is easier to live in a reactive rather ...
 Animal Pharm News3 weeks ago
Monthly Prescribing Reference

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Ann

Start Preamble Food and Drug Administration, HHS. Final rule; announcement of effective date. The Food and Drug Administration (FDA or we) is announcing the effective date for the definition of qualified auditor in the two final rules that ...
 Federal Register1 month ago Motion Sickness Patch Currently in Shortage  Monthly Prescribing Reference3 weeks ago
Nutraceuticals World

Mazza Innovation Earns NSF GMP Registration

Mazza Innovation Ltd.'s Delta, British Columbia botanical extraction facility is now a Good Manufacturing Practices (GMP) facility registered by NSF International. Mazza's facility produces clean-label botanical extracts for health, nutrition, ...
 Nutraceuticals World1 month ago Mazza earns GMP registration for botanical extraction facility  Institute of Food Technologists1 month ago Mazza Innovation Earns GMP Registration for Botanical Extraction Facility  Food Ingredients First1 month ago
Times of India

Failure to comply with norms in pharma sector a big risk: Experts

AURANGABAD: Members of the Indian Pharmaceutical Association (IPA) and Food and Drugs Administration (FDA) officials called for proper practices and regulation to be in place for the pharma industry. "India of the biggest generic industries in the ...
 Times of India10 hours ago The FDA And Big Pharma Are Too Cozy  Before It's News6 days ago FDA to host Food Safety Modernization Act webinar on Oct. 14  National Grain and Feed Association2 weeks ago FDA Tackles Terrorism and Adulteration  Food Quality2 weeks ago

Quality Issues Found at Brazil Drug Manufacturing Facility

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations. On August 25, 2016, FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A following an inspection of the company's facility in ...
 PharmTech.com1 day ago
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