• Health Canada Updates CGMP Guidance for Biologics and Blood Products

    Health Canada has updated its current good manufacturing practices (CGMP) guidelines for Schedule D (biological) drugs and human blood and blood components. The updated guidance covers 13 distinct areas of CGMP compliance: Premises : Sets recommendations for manufacturing facilities, including screening areas for blood donors, secured quarantine storage and handling areas, separate areas for testing biological samples and storage requirements. Equipment : Sets rec...
  • ICH Working Group Calls for Revisions to Q7 Guideline

    The International Conference on Harmonisation (ICH) has published a new concept paper regarding the standardized regulation of good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), the first step in reforming the organization's Quality 7 (Q7) Guideline. The paper, endorsed by ICH's Steering Committee in October 2012 and released in November 2012, refers to the widely-used Q7 GMP Guidance for APIs , released in November 2000. The document, I...
  • US Regulators Crack Down on Supplement Manufacturers

    The US Food and Drug Administration (FDA) has moved against three dietary supplement manufacturers for allegedly marketing their products using claims that would cause them to be drugs under the Federal Food, Drug and Cosmetic Act , as well as quality deficiencies. The three announcements came between 23 and 25 October-an unusually high rate of enforcement activity against a particular sector. The first action , taken against New York-based Confidence, Inc., related t...
  • FDA Slams Supplement Manufacturer for Unsterile Practices, Unknown Boxes of Product

    • 23 October 2012
    The US Food and Drug Administration (FDA) has sent a warning letter to dietary supplement manufactured Advanced Nutritional Technology (AN) Inc . after regulators said an inspection found deficiencies that caused the products to be adulterated under federal law. AN calls itself an international, specialist manufacturer of all-natural nutritional supplements. FDA's warning letter, sent 16 October 2012 and published on 23 October, largely concerns violations of federal c...
  • Chronic Regulatory Compliance Issues Causing Shortages, Safety Problems

    • 18 October 2012
    Chronic regulatory lapses at manufacturing facilities are exacerbating drug shortages and patient safety issues, claims a new report published in The New York Times . The report chronicles the huge number of issues-some of them particularly egregious-that have occurred in recent years at facilities responsible for manufacturing pharmaceutical products. The problem is especially prominent at facilities that manufacture sterile injectable drugs, which have experienced...
  • Chinese Firm Threw FDA Inspectors out Mid-Inspection, Agency Says

    The US Food and Drug Administration (FDA) regularly inspects thousands of manufacturing facilities around the globe. What isn't so regular is the owners of one of those facilities throwing FDA inspectors in the middle of an inspection and in the midst of allegations of serious manufacturing problems. According to FDA, the agency had arranged to inspect Fercy Personal Care Products' Jinhua, China-based manufacturing facility between 5 March and 9 March. The inspection sta...
  • Feature ArticlesFeature Articles

    Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices

    This article reviews the current state of the development of quality system requirements for combination products, in particular prefilled drug delivery devices. As part of a series on US Food and Drug Administration (FDA) regulation of combination products, 1-9 it discusses industry's response to FDA's proposed rule on quality systems for combination products and how manufacturers of combination products should prepare for compliance with the anticipated final rule and ...
  • Warning Letter Analysis: Siemens, Terumo Cited for Adulterated Devices

    • 20 June 2012
    The US Food and Drug Administration (FDA) sent warning letters in May 2012 to Siemens Healthcare Diagnostics, Inc and Terumo Medical Products Hangzhou Company Ltd accusing the companies of manufacturing adulterated products in violation of federally mandated Quality System Regulations (QSRs). For one of the companies, the warning letter effectively bars its products from being imported into the US. Siemens Healthcare Diagnostics, Inc. (Medical Device) In its 10 May ...
  • Warning Letter Analysis: Supplement Manufacturers Cited for CGMP Violations, Lawncare

    • 12 June 2012
    The US Food and Drug Administration (FDA) is continuing to crack down on dietary supplement manufacturers for alleged current good manufacturing practices (CGMP) violations, sending out two more warning letters to northeast supplement manufacturers NatureMost and Himalayan Institute of Buffalo. Among this batch of warning letters' most prominent warnings: swapping ingredients without warning, violative marketing claims and a failure to cut the grass. NatureMost of New ...
  • Warning Letter Analysis: Medical Device Companies Cited for Marketing Unapproved Products

    • 06 June 2012
    The US Food and Drug Administration's (FDA) latest batch of Warning Letters, released 6 June, cites three companies who are alleged to have violated current good manufacturing regulations and, in two cases, federal law by marketing unapproved products. Siemens Healthcare Diagnostics (Medical Device) In a 29 May warning letter sent to in medical device manufacturer Siemens Healthcare, FDA alleges the company's ADVIA Centaur iPTH immunoassay products manufactured at it...
  • China: New Draft Rules On Excipients

    China's State Food and Drug Administration (SFDA) issued draft rules on 4 June that would require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production.  The draft establishes drug manufacturers as having the primary responsibility to assure the quality of excipients obtained from suppliers The goal of the draft rules is to "realize the full supervision of the pharmaceutical production and s...
  • Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall

    Common are the concerns about good manufacturing practices at pharmaceutical manufacturing facilities. The US Food and Drug Administration sends out dozens, if not hundreds, of warning letters each year to pharmaceutical companies found to be violating basic standards of cleanliness, sterility or quality. Less common are concerns registered by FDA towards pharmaceutical compounding companies, which make medications to unique specifications from scratch using raw material...