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October 2017

No. 303


Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

PDA Conference: Baxter Cuts 483 Rate with Quality Matrix

Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More

FDA Researchers Seek Ways to Avoid Shelf-Life Chemical Reactions in Complex Proteins

FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals. Read More

FDA Officials Highlight Compliance and Warning Letter Trends

CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More

Warning Letter Roundup: FDA Moves Against GMP Violators

Makers of compounded drugs, dietary supplements and OTC treatments, at home and abroad, drew warning letters from the FDA. Read More

FDA Publishes List of Products Compounded by Outsourcing Facilities

For the first time, the FDA is publishing a list of the drugs manufactured by registered outsourcing facilities. Read More

FDA Moves Against Internet Drug Retailers

The FDA has cracked down on a host of operators peddling prescription drugs online, claiming the vendors are selling the drugs without a prescription, or marketing the drugs in a way that is not approved by the agency, or both. Read More

FDA Updates Guidelines on Quality Testing to Include Health Canada

The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More

UK Firms May Have Trouble Lifting Non-Compliance Marks Post-Brexit

The European Medicines Agency said it may become more difficult for UK firms to have GMP non-compliance statements lifted following Brexit. Read More

Expert Lists Data Integrity Red Flags for Drug Sponsors

Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at the RAPS’ 2017 Regulatory Convergence meeting. Read More

483 Roundup: Sterile Conditions Elude Drug Producers, FDA Says

Shortcomings in sterile drug processing landed three companies in trouble with the FDA, while a fourth was chastised for neglect of a customer’s complaint, as reflected in Form 483 inspection reports. Read More