Category: Latest For PQG Members

Update from 2023 PQG AGM – PQG Membership fee to change

The PQG committee recommended an increase in the annual fee for paying members from £17.50 to £25 and this was accepted at the AGM held on 21st March 2023.

We believe £25pa is a realistic annual membership fee for our professional organisation, the fantastic benefits in discounts for attending events and purchasing documents will remain. Attending just a single one day meeting at the member’s rate still recovers the annual fee at the new rate. Additionally the PQG website includes the valuable resource of all the material from each PQG event accessible only in the member’s only area. With no increase in the £17.50 fee for many years, the PQG committee considered now is the time to set a more appropriate rate for the paying membership.

Members of CQI, MHRA inspectors and PQG life members do not pay the membership fee.

For other PQG members the membership fee for joining or renewing will be £25 starting from 1st April 2023. To avoid any issues for renewal, please do remember to advise the membership secretary of any change in contact details by email to membership@pqg.org

Thank you for your continued support with all PQG activities. If you have any questions or would like to volunteer to help with review of PQG Monographs please contact me on chairman@pqg.org

 

Dave Waddington

PQG Chairman

EXCiPACT’s Good Warehousing Practices (GWP)

EXCiPACT has two core standards covering manufacturing operations (GMP) and repacking and relabeling activities (GDP). However, the excipient supply chain includes those who only transport and store the materials in a facility.

For these organisations, the GDP standard is too detailed as it includes repacking operations where the excipient may be exposed to the environment. To help transport and warehousing operations maintain high standards of excipient safety EXCiPACT has developed a focused, leaner, standard for these operations.

This is called Good Warehousing Practices (GWP).

The objective of excipient GWP is to ensure that:

• the receipt, storage, despatch, and transportation of closed pack excipients maintain material with the desired quality characteristics,

• it assures product integrity, traceability, and consistent quality,

• it avoids product contamination, and

• it ensures that appropriate records are maintained.

 

Since the operations in the warehouse are much simpler than those operations practised at excipient manufacturers and distributors, audit durations are likely to be shorter with many being completed in one day.

As a result, the EXCiPACT Certification fee is only €2000 for a 3-year certificate for these operations.

More details can be found here or requested at info@excipact.org

 

Below you can find the webinar held earlier in 2021 by Dr. Iain Moore – President of EXCiPACT.

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 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).

In scope

  • A UK or Great Britain licensed medicine for use in Great Britain
  • A UK or Great Britain licensed medicine for supply to another third country
  • A Northern Ireland or approved country licensed medicine for supply to fulfil special clinical needs
  • A Northern Ireland or approved country licensed medicine imported as an introduced medicine for supply to another third country
  • A Northern Ireland or approved country licensed medicine for use as a parallel import

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 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 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).

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 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.

Q&A from MHRA meeting now available

The initial set of written answers to the questions posed at the PQG annual meeting with MHRA in 2019 are now available in the members’ area.  The remaining answers will be provided by MHRA as soon as possible.

Do you want to expand your experience?

Have you ever realised that working within PQG in one of its Monograph groups actually brings you into contact with more experienced PQG Members and allows you to add another line to your CV.

We have several projects running at present writing new and revising other Monographs, so contact Phil Butson on this address Monographs@pqg.org if you are interested.