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  • Regulatory NewsRegulatory News

    European Commission Consults on Revised GMPs for Sterile Drugs

    The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...
  • Regulatory NewsRegulatory News

    Updated FDA Manual Offers Inside Look at Inspection Protocols

    The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect. The 127-page chapter offers the basics for how FDA inspectors should go about conducting what it calls, a "careful, critical, official examination of a facility to determine its compliance with laws administe...
  • Regulatory NewsRegulatory News

    FDA Warns Singapore Ophthalmic Drug Manufacturing Site

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 16 March to Singapore-based Opto-Pharm for its failure to address leaking containers and bottle defects, among other violations. FDA notes that the company, which manufactures sterile eye and skin washes , documented "numerous leaking containers and other bottle formation defects" and subsequently received consumer complaints of leaking containers after adjusting its equipment and resumi...
  • After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ

    In February 2013, the US Department of Justice (DOJ) announced it would be making the enforcement of the US Food and Drug Administration's (FDA) current good manufacturing practices (CGMPs) one of its "top areas of focus" for 2013. And while the ultimate effects of that effort have yet to be realized, at least one pharmaceutical manufacturer is now feeling the brunt of DOJ's enforcement activities. Bad Inspections In a 26 August 2013 announcement, DOJ said it has file...
  • Watchdog Group: FDA Failed to Shut Down Compounder Earlier, at Blame for Outbreak of Infections

    What did government officials know, when did they first know it, and what did they do in response? It's a classic question faced by nearly every agency in the US government, including the US Food and Drug Administration (FDA), which has in recent months been under pressure from legislators regarding its oversight of the pharmaceutical compounding industry. In light of a massive outbreak of fungal meningitis that has since been linked to products manufactured at a Massach...
  • Compounded Products Linked with Potential Deadly Infections, Putting New Pressure on FDA, Congress

    A steady drumbeat of recalls related to potentially non-sterile products manufactured at compounding pharmacies continues, with the US Food and Drug Administration (FDA) issuing announcements this weekend that Specialty Compounding LLC was recalling "all lots of sterile medications within expiry" after at least 15 patients experienced bacterial infections after being given the medication. Background FDA regulates pharmaceutical compounders differently than traditional m...
  • Franck's Pharmacy Issues Extensive, 'Urgent' Recall After Facility Contamination

    Pharmaceutical compounder Franck's Pharmacy issued what it called an "urgent" recall of all of its sterile human and veterinary products after an inspection by the US Food and Drug Administration (FDA) found fungal growth and microorganisms in a supposedly sterile room. "In light of the FDA's findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control,...
  • China: Deadlines Established For Opthalmic GMP Implementation

    The Chinese State Food and Drug Administration (SFDA) issued a notice on 25 April to Chinese Provinces and Municipalities regarding the deadlines for implementing the revised Good Manufacturing Practices (GMPs) for ophthalmic solutions. The circular pointed out that the implementation of revised GMPs for sterile pharmaceuticals and sterile bulk drugs is effective as of 31 December 2013. These sterile bulk drugs include ophthalmic preparations, such as those for intra...
  • As Final Guidance is Released, Deadline for PET Drug Compliance Draws Near

    Manufacturers of positron emission tomography (PET) drugs have until 12 June 2012 to comply with new regulations posted by the US Food and Drug Administration (FDA) on 10 April, reports In-Pharma Technologist . As Regulatory Focus previously reported, FDA has released draft guidance for FDA Oversight of PET Drug Products- Questions and Answers on 27 February, and released final guidance under the same name on 10 April. While the comment period for that final gu...
  • FDA Publishes New Guidance on PET Drug GMPs

    The US Food and Drug Administration (FDA) is releasing a final guidance on positron emission tomography (PET) products to help manufacturers of the drugs meet the agency's requirements for good manufacturing practices. FDA's guidance, Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs , deals with sterile manufacturing practices for PET products. "Most PET drugs are designed for parenteral administration and are produc...
  • FDA: After Recall of 300M Wipes, New York Manufacturer Still Failed to Test Products

    A report issued by the US Food and Drug Administration (FDA) is faulting a New York-based company for failing to test its sterile wipe products even after recalling hundreds of millions of products due to bacterial contamination, reports The Bellingham Herald. The company, Professional Disposables Incorporated, initiated a recall in September 2011 involving 300 million alcohol pads which were supposed to be sterile but were instead contaminated with Bacillus cerus. Tha...