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Home » Newsletters » Drug GMP Report

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Drug GMP Report

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November 2016

No. 292
  • Headlines

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Full Issue of Drug GMP Report in PDF Format

November 7, 2016
Download and view the full issue. Read More

FDA’s New Inspection Protocol Expected to Bring Consistency

November 7, 2016
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More

Facility Dossiers, Expert Hotline to Support Next Generation of Inspectors

November 7, 2016
A wave of retirements has led to a changing of the guard among the FDA inspectors, and now many inspectors lack experience. Read More

Sanitation Among Violations Cited by French Inspectors at Nandu Chemicals

November 7, 2016
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More

Guidance on Insanitary Conditions at Facilities Gets Mixed Reviews

November 7, 2016
The draft FDA guidance on insanitary conditions at drug compounding facilities got mixed reviews in comments on the draft. Read More

EMA Urges Drug Regulators to Boost Collaboration on GMPs

November 7, 2016
The European Medicines Agency is encouraging global regulators to collaborate on life science initiatives after a review of international projects found that several countries pursue common goals without sharing resources or information. Read More

Company Failed to Test Product, FDA Says

November 7, 2016
The Yangzhou Hengyuan Daily Chemical Plastic Co. received a warning letter after the FDA found that one of its drugs was missing the active ingredient and that the company was not testing finished batches of drug products. Read More

EMA Probing Wanbury for Falsifying Labels

November 7, 2016
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More

GSK Settles SEC Charges of Bribery in China for $20 Million

November 7, 2016
British drugmaker GlaxoSmithKline will pay $20 million to settle the Security and Exchange Commission’s charges that the company bribed healthcare professionals to boost drug sales in China. Read More

Swiss Lab Falls Short on Quality Control, FDA Says in Warning Letter

November 7, 2016
Laboratoire Sintyl, based in Switzerland, was cited for multiple quality control problems in an FDA warning letter. Read More

Sterility Testing, Other Issues Lead to Warning Letter for Teva

November 7, 2016
Teva Pharmaceuticals has received a warning letter due to sterility testing and contamination issues at its plant in Godollo, Hungary. Read More

Data Integrity Issues Lead to Warning Letter for Czech Facility

November 7, 2016
Interpharm Praha has received an FDA warning letter that cites data integrity issues at a facility in the Czech Republic. Read More

Novartis Closes Overseas Plants in Cost-Cutting Effort

November 7, 2016
Novartis is closing several of its research operations in Switzerland and China and cutting 175 jobs in an effort to centralize control of its drug discovery programs and contain costs. Read More

Recordkeeping Issues Cited in Form 483 for Belcher Pharmaceuticals

November 7, 2016
Recordkeeping and reporting issues were cited multiple times in a Form 483 issued to Belcher Pharmaceuticals. Read More

FDA Adds 24 Entries to List of Drugs That Cannot Be Used in Compounding

November 7, 2016
The FDA is revising the list of drug products that have been banned or removed from the market for safety or effectiveness reasons and so cannot be used in compounding. Read More

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