• Week 36 – News

    Week 36 – News

    Just in case you missed some of this week’s news, here are the highlights: MHRA published on 1 September 2020 guidance for industry and organisations to follow after the end of the transition period. From 1 January 2021, the Medicines and …Read More »
  • EU Exit – Acting as a RPi – Responsible Person (import) from 1 January 2021

    EU Exit – Acting as a RPi – Responsible Person (import) from 1 January 2021

    From 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the ‘Responsible Person (import) (RPi)’. The guidance published on 1 …Read More »
  • IPEC Position Paper on Excipients GMP standards and guides

    IPEC Position Paper on Excipients GMP standards and guides

    IPEC have issued a position paper outlining the content and purpose of three documents* addressing GMP requirements for excipients and the role that each can play in the implementation of appropriate GMP in the QMS of an excipient manufacturer.  This …Read More »
  • EXCiPACT 2Q 2020 Board Report now available

    EXCiPACT 2Q 2020 Board Report now available

    PQG has received the 2Q 2020 Board Report from EXCiPACT and this may be read hereRead More »
  • Meeting report: Trainee QP, Sponsors and QP CPD meeting, 30-Jun-2020

    Meeting report: Trainee QP, Sponsors and QP CPD meeting, 30-Jun-2020

    Our very first virtual event was held on 30th June, dedicated to our QPs, Trainee QP and Sponsors. The event was held using the “WebEx Training” platform and limited to 30 attendees. The attendees varied in background and experience, from …Read More »
  • New monograph: GDP for Active Substances

    New monograph: GDP for Active Substances

    If medicinal products are to be of the quality consumers and regulators expect, then the active substances within them need to be manufactured in accordance with Good Manufacturing Practice and their quality and integrity maintained throughout the supply chain through …Read More »
  • Extension to deadline for Nitrosamines risk assessments

    Extension to deadline for Nitrosamines risk assessments

    A number of recalls have occurred in the last two years following the finding of nitrosamine impurities in medicinal products, firstly the ‘sartans’ and then other products, notably ranitidine.  This has led to enhanced regulatory agency and pharmaceutical industry action to …Read More »
  • MHRA Covid-19 collection and GxP inspections news release UPDATED

    MHRA Covid-19 collection and GxP inspections news release UPDATED

    The MHRA have created a collection on their website for information related to Covid-19.  Of particular interest to members will be information about clinical trials and MHRA services.  The collection may be found here. Separately, MHRA have issued a news …Read More »
  • Making Pharmaceuticals postponed

    Making Pharmaceuticals postponed

    With the ongoing Covid-19 situation, the organisers of Making Pharmaceuticals have reluctantly decided not to go ahead with the rearranged dates of 26/27 October 2020, but will now not hold a physical event at the Ricoh Arena until July 2021.  However, …Read More »

Week 36 - News

Just in case you missed some of this week’s news, here are the highlights: MHRA published on 1 September 2020 guidance for industry and organisations to follow after the end of the transition period. From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.... Read more

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