Author: Paul Andreianu

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

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).

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.

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.

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. 

July 2021 – Updates from PIC/S

July has been a busy month with plenty of updates from PIC/S.

At the beginning of July 2021, PIC/S published the guidance on ‘Good Practices for Data Management and Integrity in regulated GMP/GDP environments’ (PI 041-1) following three drafts, the last being in November 2018.

It is understood that at the same time two aide memoires were also published for regulatory inspectors only – one generally on the ‘Inspection of Data Management and Integrity’ and one on the specifics for chromatographic data systems.

Later in the month (on 15 July), PIC/S published the recommendation on ‘How to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management’ (PI 054-1) and ‘COVID-19 RISK ASSESSMENT FOR NATIONAL ROUTINE ON-SITE INSPECTIONS’ (PI 055-1). 

(PI 054-1) “… provides practical guidance for GMP inspectors when seeking to evaluate the effectiveness of a company’s pharmaceutical quality system (PQS) in relation to risk-based change management. It covers all relevant steps in the change management process – change proposal, change assessment, change planning and implementation, change review and effectiveness checks. It indicates within each step the aspects that render the PQS to be effective in that area.

Given this, it makes sense for you to use it to assess your own change management process before your next inspector does so!

The Purpose section provides some useful reminders of the GMP requirements for an effective PQS incorporating GMP and Quality Risk Management (QRM) generally and for a change management system in particular. It also notes that QRM is a key element of ICH Q10 and that a mature risk-based change management within an effective PQS is essential to enable greater regulatory flexibility in the reporting of post-approval changes under ICH Q12.

The checklist component of the document takes up just over three pages and follows the change management lifecycle:

• Proposals (determination of when a change is needed, including a non-limited list of common lifecycle factors that trigger change);
• Risk Assessments;
• Planning and Implementation;
• Review and Effectiveness:

o Prior to change closure;
o Prior to or after change closure, including closure of any post-implementation actions.


The checklist is worth working through in detail, but a few highlights include:

  • Clear documentation is required throughout.
  • The various possible impacts of changes need to be assessed.
  • The planning and implementation should include potential risks with the current state (until changes are implemented) and any risks that might be temporarily introduced during the change process.
  • Situations where proposed changes are not implemented also need to be covered.


In line with ICH Q9, there is allowance for the level of risk associated with a change to drive the formality and complexity of the documentation. Consideration of current process knowledge and the product/facility lifecycle is flagged. “At a minimum, changes should maintain or improve product quality and/or patient safety, and should not increase process variability.” The data needed to demonstrate effective implementation of the change should be pre-defined in change planning and confirmed on review.

Regulatory filing implications need to be addressed. 

Prepared by the PIC/S Working Group on Inspectors Safety, PI 055-1 is a risk assessment template intended to be used by inspectors, in conjunction with host sites, during the planning phase of announced GXP inspection of national sites.

It is expected that the site confirms that the necessary measures identified in the risk assessment will be implemented.

It is also noted that consideration should also be given to Covid testing of Inspectors pre and post inspection and that this may be requested by some sites. There should be two-way communication between inspectors and sites of any positive Covid test of involved personnel within the inspection window.

It is worth looking through all elements of this document and it would form a good template for any third-party audits you conduct, if you do not already have a risk assessment for these in place.

From a host site perspective, note that meeting rooms should be of an appropriate size to maintain social distancing with the number of hosts present within the same space and interacting directly with the inspector limited; if larger numbers of attendees are required then aim for participation via remote technology. Rooms should be well-ventilated, with working surfaces should be disinfected regularly.

If any of the company personnel do not co-operate with the requests of social distancing and the additional current government guidelines or become uncooperative to the NCA personnel, the inspector will leave the site immediately”, which is clearly something to be avoided!


PQG is the longest established of the CQI’s special interest groups, which for over 30 years has met the needs of quality professionals within the pharmaceutical industry. 

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