Latest news

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  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

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


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

World Quality Week 2022

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.

ATMP Roadmap

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 Qualified Persons Eligibility Scheme News Bulletin

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.


The Joint Professional Bodies intend on hosting the next QP Symposium on the 11th May 2022 in London. More information will be provided in due course.

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


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

July 2021 – Updates from WHO

July 2021 had plenty of updates in the pharmaceutical space from the World Health Organization. As part of its weekly update for members and the general public, PQG provides a summary of these below. 

Back in 2020, the WHO published draft documents on ‘Good Manufacturing practices for medical gases’, ‘Good Manufacturing Practices for Investigational Products’ and ‘WHO Good Practices for Research and Development Facilities of Pharmaceutical Products’.

After the consolidation of comments received and a review of the feedback, revised versions of the three guidelines have now been published for the second round of public consultation. (check links for each draft guideline)

The deadline for comments is 31 August 2021. You can have your say by using the enclosed template

These along with other WHO publications can be found at the WHO Medicines website under ‘Working Documents in Public Consultation’.


The need for a ‘GMP for medical gases‘ comes from increased demand for medicinal gases, in particular the use of oxygen in the treatment of patients with Coronavirus disease 2019 (COVID-19). As a result of this, the World Health Organization (WHO) Health Products Policy and Standards Department (formerly Essential Medicines and Health Products) and other departments involved in the supply of oxygen and the inspection of production sites of medicinal gases, raised the urgency for the preparation of the WHO good manufacturing practices for medicinal gases guidance text.

This guideline focuses on the production, control, storage and distribution of medicinal gases, however, it does not cover the manufacturing of medicinal gases in hospitals or at home for personal use. Despite this, the principles contained in this document may be applied in those instances to ensure that oxygen generated at hospitals or at home are suitable for their intended use and meet the appropriate quality standards.


When it comes to the draft guideline on ‘WHO good manufacturing practices for investigational products‘, the recommendations are mainly applicable to investigational products for human use; its principles should be considered in early phase clinical manufacture.

WHO good practices for research and development facilities of pharmaceutical products‘ is specifically applicable to research and development facilities of pharmaceutical products procedures, processes and data that are intended for transfer and submission for approval in marketing authorization applications, process validation, TOT-related activities, validation, quality control laboratory activities such as stability testing and development, and validation of cleaning procedures. 

The main focus of this document is to provide for GxP in the production and control of pre-clinical and not for human use batches, manufactured in pharmaceutical formulation and development facilities, where these are directly supporting.

The principles described in this document may be applied in facilities where other products, such as biopharmaceutical products, vaccines and medical devices, are manufactured.

This guide excludes whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), medicinal gases, radiopharmaceuticals and gene therapy products.

The GxP outlined below are to be considered general guides and they may be adapted to meet individual needs. The equivalence of alternative approaches, however, should be demonstrated.

MHRA’s webinar on protecting the security of the UK supply chain – 13 August 2021 – 10 AM UK time

This MHRA webinar will raise awareness of the threat of stolen medicines being re-introduced into the regulated supply chain.

The event will be delivered by GDP Inspectors with expert knowledge of the issue and the capability to offer practical advice on steps the audience can take to protect themselves and patients from the threat and how to report suspicious activity.
This MHRA webinar is targeted at but not limited to: Wholesale dealer authorisations holders, Brokers, Responsible Persons and Quality Assurance personnel associated with wholesaling medicines.


To register for this free webinar use the following link.

For PQG events, add this link to your browser bookmarks or subscribe for updates. 

©2004-2023 Pharmaceutical Quality Group. All rights reserved. | Copyright, Disclaimer and Privacy Policy

Web site design and development by Futuresys Ltd