• Investigation of Indian Manufacturer Finds Deficient Testing Practices, Falsified Records

    A Warning Letter sent by the US Food and Drug Administration (FDA) to an Indian pharmaceutical manufacturer alleges that the company routinely repeated tests when initial testing did not give it the desired results and, in at least one case, improperly back-dated results. The 28 May 2013 Warning Letter references two inspections conducted by FDA, one in November 2012 of RPG Life Sciences' Ankleshwar, Mumbai facility and the other a January 2013 inspection of its Navi, ...
  • TGA Opens Consultation on Rolling Adoption’ of PIC/S GMP Changes

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on implementing a 'rolling adoption' of new good manufacturing practice (GMP) versions of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S), two international instruments designed to improve co-operation between regulatory authorities and the pharmaceutical industry. The proposal would automatically adopt the new PIC/S changes during a transition p...
  • New FDA Guidance Recommends Use of Quality Agreements to Define Contract Responsibilities

    The US Food and Drug Administration (FDA) has released a new draft guidance regarding contract manufacturing arrangements, establishing the responsibilities of each entity involved in the manufacture of a pharmaceutical product in adherence to current good manufacturing practices (CGMPs). Background The draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements , comes just as FDA has been identifying lapses in contract manufacturing arrangem...
  • Pfizer Subsidiary Hit with Warning Letter for CGMP, Reporting Problems

    A warning letter sent to an Italian subsidiary of Pfizer, Wyeth Lederle S.p.A., by the US Food and Drug Administration (FDA) claims that the company's Catania, Italy manufacturing facility has significant manufacturing and reporting deficiencies which may prevent the company's products from entering into the US. CGMP Issues The letter references a July 2012 inspection of the Catania plant where FDA inspectors say they found unexplained discrepancies that went uninvestig...
  • Rare Multi-Facility Warning Letter Slams Manufacturer, Says Concerns Extend to All Plants

    A Warning Letter sent by the US Food and Drug Administration (FDA) to generic manufacturing company Apotex, Inc. cites a number of "serious" current good manufacturing practice deficiencies found at two manufacturing sites maintained by the company-a rarity among FDA Warning Letters. The 21 February 2013 letter references a 13-24 August inspection of two Canada-based facilities operated by the company. Facility One: Toronto At the first facility, FDA claimed the compan...
  • RAPS' LatestRAPS' Latest

    FDA Final Rule on Manufacturing of Combo Products Likely to Answer Some Questions, Raise Others

    The US Food and Drug Administration (FDA) recently released its final rule on current Good Manufacturing Practices (CGMPs) for combination products. In its Federal Register notice on the final rule, FDA wrote that it "sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for 'single-entity' and 'co-packaged' combination products." According to Tom Hutchinson, vice president of regulatory af...
  • Ben Venue, FDA Receive Approval for Consent Decree, Potentially Easing Drug Shortages

    The US Food and Drug Administration (FDA) has received approval from a federal judge for a consent decree of permanent injunction between it and Ben Venue Laboratories, a manufacturing facility long in the crosshairs of the agency's enforcement officials. Background The company, a subsidiary of Boehringer Ingelheim, suspended its manufacturing capabilities in 2011 after receiving a string of warning letters from FDA over the maintenance of its current good manufacturing...
  • Brazil Drops International GMP Inspection Proposal

    The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites. Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution. Moreover, elements of the earli...
  • Long-Sought-After Rule on CGMPs for Combination Products Released by FDA

    • 22 January 2013
    The US Food and Drug Administration's (FDA) Office of Combination Products (OCP) has released a new final regulation on the current good manufacturing practices (cGMPs) used in the manufacture of combination products. Background Combination products are, as their name implies, a combination of two or more product classes, such as a medical device, biologic and a pharmaceutical product. They are typically regulated by analyzing their constituent parts to determine thei...
  • Repeat Deficiencies Form Basis of Warning Letter to Veterinary Pharmaceutical Manufacturer

    • 13 December 2012
    A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility. The company, Performance Products Inc (PPI), was accused of "significant deviations of Current Good Manufacturing Practice (CGMP) regulations" in the 20 November 2012 letter. PPI manufactures a number of products aimed at bovine and equine species, with most of those products being probiotic in nature. The company's website boats about it...
  • Chinese Firm Used White Out to Change Regulatory Records, FDA Says

    Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations. The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In ...
  • Health Canada Announces Adoption of New GMP Standards for Active Ingredients

    Canadian public health officials have announced the expansion of Health Canada's regulatory authority to inspect and require all active ingredients(AIs)-sometimes referred to as active pharmaceutical ingredients (APIs)-to meet current good manufacturing practice (CGMP) standards. The change in some ways reflects a change in the way pharmaceutical products are now manufactured. Many facilities will manufacture just AIs or APIs, sending the finished product to a second man...