Author: Sarah Powell

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.

 

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.

 

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.

Hot Topics Meeting with the MHRA and Industry Experts

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.