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About 811 results for "cgmp"

PixarBio Builds Commercialization Team Adding Regulatory Affairs, CGMP Manufacturing, Sales/Bus Dev, And Medical Affairs

PixarBio Builds Commercialization Team Adding Regulatory Affai...

Reddit Email Print Reprint PixarBio Corporation today announced expansion of the leadership team, to maintain momentum toward multiple FDA approvals of non-opiate and non-addictive pain treatments in 2017. Dr. Amer Khalil, PixarBio ..., 1 week ago
Bio Spectrum Asia

BeiGene to build its first cGMP facility in Suzhou BioBAY

 Bio Spectrum Asia1 week ago BeiGene to build cGMP production plant for commercial use in Suzhou, China24-08-2015  Pharma Letter1 week ago
IFI Online

Ohly announces probiotic yeast

Following its successful cGMP certification and newly confirmed status as an authorised API (Active Pharmaceutical Ingredients) manufacturer, Ohly has announced the release of Auxoferm Saccharomyces boulardii a probiotic yeast that the company ...
 IFI Online1 week ago Developing & Training a Staff for the cGMP Manufacturing of Highly...  PRWeb2 weeks ago
Bioresearch Online

Automation necessary to ensure cGMP compliance in pharmaceutical facilities

Air conditioning is an integral part of the pharmaceutical industry. Ensuring pharmaceutical products are manufactured in the required contained and controlled environment is very essential if the product potency is to be maintained during its shelf ...
 PharmaBiz1 month ago Revisiting Manufacturing Facility Design: A CFO Takeaway  Bioresearch Online2 days ago ONGC, Infosys, DLF and Aurobindo Pharma to see some action  Finalaya.com4 days ago Aurobindo Pharma Targets a Revenue of Over (Dollar) 3 Billion by 2017-18  MedIndia1 week ago

cGMP enforcement and compliance in the wake of Rostholder

In recent years, the Department of Justice (DOJ) has increasingly pursued pharmaceutical companies for alleged noncompliance with current good manufacturing practices (cGMP), and companies have faced criminal and civil penalties in the hundreds of ...
 Lexology1 month ago
Natural Products Industry Insider

Scientifically Sound Specifications: No "By-Inputs" Here

The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must be ...
 Natural Products Industry Insider1 week ago Elements of Current Good Manufacturing Practices (cGMP) for Complying with the Food Safety Modernization Act (FSMA): 2-Day In-Person Seminar (Orlando, FL)  Research and Markets1 month ago
Natural Products Industry Insider

How to Audit and Qualify Manufacturers, Service Providers for cGMP Compliance

In hundreds of inspections carried out by FDA since 2009—based on inspection observations released by FDA, many dietary supplement contract manufacturers have been found to be deficient in basic areas of cGMPs (current good manufacturing ...
 Natural Products Industry Insider2 weeks ago

FDA Warns Another Foreign API Maker for Data Integrity Issues

Indian active pharmaceutical ingredient maker Mahendra Chemicals was hit with an FDA warning letter for cGMP deviations including data integrity issues — the latest in a crackdown on foreign API makers. During the May 19 to May 24, 2014, ...
 FDA News1 month ago Indian API Manufacturer Cited for Recordkeeping Failures  PharmTech.com1 month ago

FDA Finds Deviations in Bio-Rad's cGMP Practices

An FDA inspection of Bio-Rad's Medical Diagnostics GmbH unit in Dreieich, Germany revealed gaps in the company's current good manufacturing practices, according to a notice on FDA's website. The letter specifically calls attention to various open ...
 BioPharm International1 month ago
Manufacturing Chemist

Efficient and cost-effective cleaning

4-Sep-2015 Manufacturing When higher cleaning efficiencies are required, it's an easy step to upgrade from static spray balls to Alfa Laval's Toftejorg SaniMidget SB rotary spray head technology. Simply unclip the static spray ball and ...
 Manufacturing Chemist8 hours ago
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