On 23 Apr 2021, EMA published an important addition to their GMDP Q&A with the publication of ‘Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs’.
The document highlights that, whilst GMP certificates are not required for manufacturing and testing sites of starting materials for ATMPs, it is mandatory to comply with the ‘principles of GMP’.
The first Q&A covers the definition of starting materials.
Q&As 2-5 then go on to explain further what is meant by ‘principles of GMP’ for different types of ATMP manufacture. The application of a risk-based approach is expected to determine the risks presented by each material to quality, safety and function, thus determining the appropriate GMP controls and other mitigation measures.
The final two Q&As reinforce that this is an obligation of the ATMP manufacturer and confirm that a qualified person is not required for the production of starting materials.
Hot Topics Meeting with the MHRA and Industry Experts – 16th March 2021.
The presentations shown at this meeting are available from the ‘Members Only’ area. Please remember to login to access.
Questions received from attendees have been submitted, and answers will be posted as soon as available.
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.
The presentations from the Trainee QP, Sponsors and QP CPD Virtual Event held on the 24th February 2021 are available in the ‘Members Only Area’. Please remember to login to access.
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).