Latest news

Auditing in Pharma – webinars

PQG has just completed a well-received series of three webinars on Auditing in Pharma jointly with the CQI Audit SIG.

The three sessions were:

  1. Auditing in the pharmaceutical industry and the PQG Auditing monograph (12 Dec 2023)
  2. Risk-based auditing, including consideration of remote audits (19 Feb 2024)
  3. Auditing from the auditee’s perspective, including the importance of the auditee to successful audit outcomes (18 Apr 2024)

The slide decks are available to all members in the Members Only area of the website (log in first to access).

Thanks to Dave Waddington, Richard Brett and Phil Butson for hosting/presenting at these webinars and to all those who attended and participated in the discussions.

If you have any suggestions for topics of similar sessions in future, or wish to be involved in making them happen, then please email Dave at chairman@pqg.org

Want to learn more about auditing?

Treat yourself to a copy of the Pharmaceutical Auditing monograph from the PQG shop (log in first to obtain the members’ discount price).

Making Pharmaceuticals Exhibition & Conference – free to attend event

PQG speakers will be presenting – visit STAND 713 

Coventry Building Society Arena, Coventry

Tuesday 23 April 2024: 09.00 – 17.30
Wednesday 24 April 2024: 09.00 – 16.00

To book a place visit https://www.makingpharma.com/

Revised Pharmaceutical Auditing monograph published

The quality of medicinal products results from the sum of many activities. End product testing alone is not sufficient to ensure product quality; an overall pharmaceutical quality system is required that builds in the quality. Quality auditing is a key management tool for monitoring and evaluating compliance and the delivery of the pharmaceutical quality system objectives, for driving continual improvement as well as assuring patient safety.

The PQG Pharmaceutical Auditing monograph has been extensively revised and expanded to reflect current regulatory requirements and changes in audit practices arising from developments in information and communications technology and Covid-19 pandemic experiences.

Given that the outcome of an audit depends on both the auditor and auditee, this monograph seeks to equip auditees in addition to being a valuable tool for auditors.  It also covers audit programme management.

The new monograph is available in both printed (A5 wire bound) and electronic (interactive .PDF) versions.  Whichever format you prefer, purchase your copy now from the PQG Shop.  PQG members receive a 20% discount on the base price, so (join first if you need to and) remember to log in as a member before making your purchase.

For optimal functionality it is best to use a PDF Reader for the interactive version, but it also works in a web browser.

Trainee QP, Sponsor and QP virtual event

On October 10th the PQG hosted the Trainee QP, Sponsor and QP” virtual event using the
“Zoom” platform.
This regular event started with the overview of the application process for QP Eligibility, covering
key aspects such as the “registration step” to confirm eligibility criteria, knowledge/experience
requirements and the viva process, by David Moulding (Registration Standards Specialist, RSC).
Attendees were split in small virtual groups to practice Viva type questions. This was a great
opportunity for trainees to discuss several scenarios, share experience and verbalise answers.
Many thanks to the speakers, facilitators and attendees. The extremely positive feedback
received will help us to shape future virtual events.
Look at our PQG web page: The Pharmaceutical Quality Group (pqg.org)/events for future PQG Events.

 

World Quality Week 2023

Celebrate excellence in Quality and #WQW23 (between 6–10 November) with us and help raise awareness of the quality management profession globally.

World Quality Week 2023 is your opportunity to celebrate your quality achievements, raise awareness of the quality management profession and focus on realising your competitive potential.

Quality: realising your competitive potential 

 

CQI has created #WQW23 resources to help you gain recognition for the great work that you do every day.

For more details, follow the link.

Another successful virtual event

Thanks to our trainee QPs who provided insight on which topics of the Study Guide they would like to practice more, enabling PQG Committee to organise another extremely successful evening event.

The Overview on IMP QP Role took place on September 26th – Dee Metcalfe’s presentation focused on the key differences between Commercial and IMP QPs and promoted an interesting and engaging Q&A session.

After the presentation, the trainee QPs were split into 6 small virtual groups, to practice Viva type questions based on IMP QP role and responsibilities. Everyone had the opportunity to practice their thought processes, share their experiences, discuss actions, agree next steps, and verbalise their answers.

As usual, presentations are available on the PQG website members area.

Many thanks to Dee and the PQG committee members who organised this event. Also special thanks to the attendees for their engagement and positive feedback.

For future PQG Events including next QP Training events please see The Pharmaceutical Quality Group (pqg.org)/events

 

 

Call for volunteers! Revision to EXCiPACT Standards 2021

EXCiPACT is a non-profit organisation that owns and manages oversight of a third-party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.  The EXCiPACT standards, to which suppliers are certified, were developed by the member organisations, of which PQG is one.  As a member of EXCiPACT, PQG are also actively involved in the review and revision of these standards.
EXCiPACT are currently seeking input for the revision of the 2021 standards to ensure that they are current, relevant, and forward looking. Recently there have been several developments such as the revision of the IPEC-PQG GMP Guide, and the USP General Chapter <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients. Additionally, regulatory scrutiny of the manufacture and supply of excipients continues to grow, and these expectations need to be considered to in any revisions.

If you are interested in being involved in the review and revision of these standards, please could you email admin@pqg.org  Please could we ask that you reply by Wednesday 13th September.

Virtual event for Trainee QPs

Another successful PQG evening virtual event for Trainee QPs was held on June 6th. A limit of 30 attendees and using Zoom (including the breakout rooms functionality) enabled effective discussions.

Mick Stuart (Contract QP and RP/RPi) presented an Overview on Annex 16, including QP Roles and Responsibilities, promoting an interesting and engaging Q&A session.

The trainee QPs were then split into 6 small virtual groups to practice Viva type questions based on complex supply chain. Everyone had the opportunity to practice their thought processes, share their experiences, discuss actions, agree next steps, and verbalise their answers.

As usual, presentations are available on the PQG website in the ‘Members Only Area’.


Many thanks to Mick and the PQG committee members who organised this event. Also special thanks to the attendees for their engagement and positive feedback.

 

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

Consultation Outcome on import testing and UK QP Certification

“After careful consideration of all the responses to the consultation, alongside other relevant information and evidence, … the government has decided to make permanent the approach of maintaining a list of approved countries for import which require no import testing or UK QP certification. This policy protects patient safety, supports the aims set out by this government in the Life Sciences Vision to stimulate a thriving UK life sciences sector and avoids adding unnecessary regulation to an already highly regulated sector. …

As this policy is currently in operation and in legislation, there is no need for a 2-year period to allow industry to prepare for implementation.”

 

More details here

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