Category: Latest Pharmaceutical News

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/

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.

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.

 

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.

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 26^th – 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

 

 

“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. 

Celebrate #WQW22 (between 7–11 November) with us and help raise awareness of the quality management profession globally.

World Quality Week 2022 is your opportunity to celebrate your quality achievements, and recognise those that use conscience in their decision-making at every level.

Quality conscience: doing the right thing.

 

CQI has created #WQW22 resources to help you gain recognition for the great work that you do every day.

For more details, follow the link.

The ABPI (Association of British Pharmaceutical Industry) and AAC (Accelerated Access Collaborative) launched at the end of 2021 an ‘ATMP Roadmap’ that has been created on their behalf by Ernst & Young with input from organisations such as the Cell and Gene Therapy Catapult, The Medicines and Healthcare products Regulatory Agency (MHRA), NHS England (NHSE) and The National Institute for Health and Care Excellence (NICE).  It is a very useful resource for anyone involved with these products.

This ATMP Roadmap is in the form of a downloadable interactive PDF and sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to patient treatment. It also signposts where differences exist between devolved nations (Scotland, Wales and Northern Ireland) or different types of ATMPs.

There are general encouragements on best practices to Engage early, Seek advice and support, Minimise complexity and Patient centricity.

 

If you have any involvement in ATMPs, you would be well advised to spend some time working your way through this very useful resource.

 

 

The Joint Professional Bodies (JPB) are committed to keeping in touch with the Qualified Person’s community and will be updating this page with a quarterly newsletter to share relevant updates and information about the QP eligibility scheme.

The bulletin published in December 2021 is available here.