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Home » Topics » Pharmaceuticals » GMPs

GMPs
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FDA Outlines GMPs for COVID-19 Infections in Workers

July 6, 2020
The FDA has released guidance for drugmakers on good manufacturing practices (GMPs) for responding to COVID-19 infection in employees. Read More

USP Supports Use of Crab-Derived Reagents for Drug Tests

July 6, 2020
After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Read More

FDA Outlines GMPs for Drugmakers Dealing With COVID-19 Infections in Workers

June 22, 2020
The FDA on Friday released guidance for drugmakers on good manufacturing practices (GMPs) for responding to COVID-19 infection in employees. Read More

USP Supports Continued Use of Crab-Derived Reagents for Drug Tests

June 5, 2020
After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Read More

FDA Eases Requirements for Some Compounded COVID-19 Drugs

April 17, 2020
The FDA is temporarily easing its requirements for more than a dozen compounded drugs needed for hospitalized COVID-19 patients. Read More

FDA Warns Indian OTC Facility for Quality Violations

September 26, 2018
The facility lacked proper validation and verification studies. Read More

FDA Warns Indian OTC Facility for Quality Violations

September 25, 2018
The FDA issued a warning letter to Wilson Medicine Company citing serious quality problems found during a Feb. 26-March 1 inspection of its OTC manufacturing facility in Nandore, India. Read More

FDA to Define GMPs for Outsourcing Facilities

February 15, 2018
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Read More

European Commission Issues New GMP Guidelines for Advanced Therapies

December 19, 2017
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More

Morrison Says ORA Reorganization Will Mean More Foreign Inspections

December 11, 2017
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, according to a high-ranking agency official. Read More

Warning Letter Roundup: FDA Flags Labeling, Sterility, Other Violations

December 11, 2017
The FDA warned four companies for illegally branding cannabidiol products as treatments for cancer and Alzheimer’s disease. Read More

European Commission Issues New GMP Guidelines for Advanced Therapies

December 11, 2017
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More
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