The MHRA has published further guidance in relation to supplying medicines and medical devices after the end of the transition period.
On medicines we have the following updates:
On medical devices:
In addition to this it worth noting that DHSC has launched the new DaSH portal and published updated guidance on the reporting requirements for medicines shortages and discontinuations. The guidance is available here.
GDP monographs will be the main topic of the webinar presented by Phil Butson (PQG) on Tuesday, 27 October.
The live webinar (GDP Requirements and the ECA/PQG Good Distribution Practice monographs) will be held on behalf of Pharmaceutical Quality Group as part of MP’s Digital Week.
PQG’s second Trainee QP CPD – Virtual Event will be held on the 20th October 2020. To facilitate the interactive nature of this meeting the number of delegates will be restricted to 30. More details and bookings here.
David Moulding (Registration Standards Specialist, RSC) will give a presentation on Applying for QP Eligibility.
In the second part of the Trainee QP CPD – Virtual Event viva type questions will be given to you to discuss in small virtual breakout groups facilitated by Romina Toppani (Quality Executive GSK, & PQG), Damian Larrington (Pfizer & PQG), Dave Waddington (Director NSF & PQG) and Neil Wayman (Global Quality Director at AstraZeneca & PQG Vice Chairman).
You will then join together to share your answers and receive advice on how to structure best potential answers, along with the key elements to consider.
On Tuesday 22 September 2020 PQG organised a Data Integrity Webinar with Dale Carter, Head of Quality – Evonik Corporation.
In this presentation, Dale reviewed the recently released position paper on Data Integrity for Pharmaceutical Grade Excipients published by the International Pharmaceutical Excipients Council Federation (IPEC).
The paper was developed to supplement published Regulatory guidance defining Data Integrity requirements for drug substances and medicinal products, some of which are not easily adaptable to the manufacture of excipients.
The presentation (supporting slides available here) covered Data Integrity principles, Regulatory guidance documents and recommendations on how to apply Data Integrity to excipient manufacturing and distribution.
Just in case you missed some of this week’s news, here are the highlights:
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.
Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.
Stakeholders need to get ready for new rules from 1 January 2021.
This guidance covers the following topics:
The draft strategy details how the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.
It outlines six priority areas for the network:
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 September 2020 describes how you can apply to be a RPi, and how to verify that QP certification of a medicine has been done in the EEA.
The registration scheme for RPi candidates will be applicable from 1 January 2021 and RPi applications may be submitted through the MHRA Portal after this date.
The Responsible Person (import) (RPi) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended) and is responsible for implementing a system to confirm that the required QP certification has taken place for products that have been imported into Great Britain (England, Wales and Scotland) from countries on an approved country for import list (initially, this will be countries in the EEA).
Out of scope
There will products which will not require RPi oversight such as medicinal products sourced from Northern Ireland. For wholesale purposes they are out of scope of this guidance and this is permitted under the supervision of a Responsible Person (RP).
Products with a UK or Great Britain marketing authorisation that are imported into Great Britain from outside the UK without QP certification from a country on the list will require QP certification under a UK manufacturing and import authorisation before being placed on the market.
Products without a marketing authorisation in the UK, Northern Ireland, Great Britain or a listed country are outside the scope of this guidance. Importation of such products is permitted under the supervision of a Responsible Person (RP), with notification to the MHRA of each importation that is for supply to the Great Britain market.
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 will be helpful to those involved in both the manufacture of pharmaceutical excipients and the assurance of excipient quality within pharmaceutical manufacturers. The paper may be found here
*1. The International Pharmaceutical Excipients Council & The Pharmaceutical Quality Group: The Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients;
2. EXCiPACT™ Certification Standards for Pharmaceutical Excipient Suppliers, GMP Annex;
3. NSF/IPEC/ANSI 363, Good Manufacturing Practices (GMP) for Pharmaceutical Excipients, American National Standard (ANSI 363).
PQG has received the 2Q 2020 Board Report from EXCiPACT and this may be read here
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 those who are training to become a QP to others who had decades of experience as QP and were using the event as a continuous development opportunity. The event kicked off with a comprehensive Pharmaceutical Regulatory and Legislative update by Pete Gough (Vice President, NSF). The use of “WebEx Training” then enabled us to split the attendees in 6 small virtual breakout groups to practice Viva type questions providing attendees with the opportunity to discuss several scenarios, share their experience and verbalise their answers. David Moulding (Registration Standards Specialist, RSC) then gave an overview of the application process for QP Eligibility, covering also some aspects related to the current Covid-19 pandemic situation.
Many thanks to all the speakers, facilitators and attendees. The extremely positive feedback received will help us to shape future virtual events – watch out for a new “trainee QP Day” later in the year!
A link to where Pete Gough’s presentation can be downloaded and a copy of David Moulding’s presentation are now available on the PQG meetings page in the members only area.
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 the application of Good Distribution Practice (GDP).
In Europe, the Falsified Medicines Directive (2011/62/EU) amended Directive 2001/83/EC to introduce legal requirements relating to the manufacture, importation and distribution of active substances. Subsequently, in March 2015, the European Commission published its ‘Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use’ (2015/C 95/01).
Having collaborated to produce a well-received monograph on GDP for medicinal products (revised PQG monograph 4, 2018), the Pharmaceutical Quality Group of the Chartered Quality Institute (PQG) and the ECA Foundation GDP Association (ECA) received several requests for similar guidance on the interpretation and implementation of the regulatory expectations of GDP for active substances. This led to the formation of a small working group and we are delighted to share the news that this has now resulted in the publication of a new monograph (PQG monograph 13).
The new monograph is built around the format and text of the 2015/C 95/01 guideline (presented in blue text) with guidance (black text) provided by experts drawn from the membership of both PQG and ECA. Where appropriate, text from the medicinal product GDP monograph has been reused as many of the same good practices apply to both products and active substances. However, the monograph also reflects the fact the regulatory guidelines for active substances are less detailed and that a risk-based approach allows for some differences. Although based on the European guideline, the advice is relevant to all geographical regions given that today’s pharmaceutical supply chains are frequently global with many distribution steps through which quality needs to be maintained.
This new monograph, which is now available from the PQG Shop, provides a sound basis for the implementation and maintenance of a GDP quality system for active substances with clear responsibilities and processes and the application of risk management principles. It will be of benefit to all involved in active substance distribution activities for initial training, continuing professional development and as a reference source or audit tool.
Thanks to the following for providing their time and expertise to produce this new monograph:
Philip Butson, Prabjeet Dulai, Martin Egger, Afshin Hosseiny, Denise Hosseiny, Saddam Huq, Sue Mann, Stephen Mitchell, Steve Moss, Wolfgang Schmitt and Neil Wayman