The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    PIC/S finalizes GMP data integrity guidance

    This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect.   When authorities inspect facilities of manufacturers and distributors of active pharmaceutical ingredients to ensure good manufacturing practice and good distribution practice (GMP/GDP) compliance, “The effectiveness of these inspection processes...
  • Regulatory NewsRegulatory News

    Updated: MHRA Suspends UK Company's MS License

    Late last month, the UK's Medicines & Healthcare products Regulatory Agency (MHRA) suspended the manufacture specials (MS) license of a UK company that recently made a push into the US. The MHRA did not reveal what caused it to suspend Bionical Limited's license , but according to MHRA's most recently updated list of suspensions, the license is suspended until 18 February 2016. Jonathan Hughes, business development director of Bionical, told RAPS that the suspension c...
  • Regulatory NewsRegulatory News

    Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions

    A group representing pharmacists in India is calling for regulators to amend the country's Drugs and Cosmetics Act to more strictly control how manufacturers specify temperature storage instructions for their products. Background The environment drugs and other healthcare products are stored in plays a critical role in ensuring their safety and efficacy. Manufacturers are required to control for a number of environmental factors, including temperature, humidity, ven...
  • Feature ArticlesFeature Articles

    Singapore’s GDPMDS versus ISO 13485:2003: A Comparative Analysis

    Good Distribution Practice (GDP) is a term first officially coined in the European Community Council Directive 92/25/EEC for medicinal products, and it is a subject that has been covered in guidelines by most major reference authorities. 1 In most of these cases, GDP is generally considered an extension of Good Manufacturing Practices (GMP). In US regulations and US Food and Drug Administration (FDA) guidelines, for example, there are no separate regulations or gu...
  • Revised EU Distribution Rules Target Falsified Medicines

    The European Commission issued final revised Good Distribution Practices (GDP) guidelines  on 8 March 2013 that are designed to incorporate the requirements of a 2011 Directive that targets so-called "falsified medicines" from entering the legal supply chain of the EU.  A draft version of the revised GDPs was issued for public comment (consultation) in July 2011 by the Commission, which noted at the time that the 1994 version of the GDPs was "no longer adequa...
  • China Finalizes Revised Drug Distribution Rules

    China's State Food and Drug Administration (SFDA) has announced the release of the revised pharmaceutical Good Supply (Distribution) Practices (GSP) slated to take effect on 1 June 1 2013, with a three-year transition period for the implementation by companies of the mandated quality control system. Drug makers who fail to meet the amended GSP standards by 2016 will not be allowed to continue operations, regulators said. This is the first major revision of the GSPs i...
  • India Issues Draft Drug GDP Guidance

    India's Central Drug Standards Control Organization (CDSCO) released on 10 January 2013  draft guidelines  on good distribution practices (GDP) for pharmaceutical products intended to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. Elements of the process include, but are not limited to, procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices.  The...
  • India's CDSCO Finalizes Guideline on Good Distribution Practices for Biologicals

    India's Central Drug Standards Control Organization (CDSCO) has finalized and released a new guideline on good distribution practices for biological products manufactured in the country. Regulators said the guideline , originally released in late September 2012 in draft form , is intended to, "Assist in ensuring the quality and identity of biological products during all aspects of the distribution process."  Guidelines on Good Distribution Practices for Biologic...
  • EMA, PIC/S to Harmonize Good Manufacturing Practices for Pharmaceuticals

    The European Medicines Agency (EMA) on Wednesday, 11 June released additional documents expanding the extent of its cooperation with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), first announced in December 2010. PIC/S-composed of PIC and the PIC Scheme, which operate in tandem-works to promote inspection quality and cooperation among member counties, which include most European countries and, as of 2011, the US Food and Drug Administration (FDA). As of 20...
  • Industry: GDP Guidelines Would Increase EU Costs

    • 22 February 2012
    Big pharmaceutical and logistics companies say draft good distribution practice (GDP) guidelines from the European Commission would "significantly increase the cost of medicinal product supply chains," according to a published report by Outsourcing Pharma .  The statement is attributed UPS, a worldwide shipper, that is concerned about the classification of any period when products are held at a site for longer than 24 hours as a regulated activity.  The r...