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NEWS

Welcome to the JPAG News page. We will continue to post items of news that we hope you will find both interesting and informative.

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Design, formulation and manufacture of film-coated drug products
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Design, formulation and manufacture of film-coated drug products", written by Dr Dave Elder, Past-Chairman of the JPAG Committee Download the article
Friday 3rd November 2017

Modernising the supply chain using continuous manufacturing
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Modernising the supply chain using continuous manufacturing", co-written by Dr Dave Elder, Past-Chairman of the JPAG Committee and Stephen Tindal and Ronak Savla, Catalent Pharma Solutions Download the article

If you found this article interesting, you should consider attending the JPAG event on continuous manufacturing, to be held on Thursday 11 March 2018 at the RSC, London.
Friday 3rd November 2017

Balancing the efficacy & safety of preservatives in multidose products
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Balancing the efficacy and safety of preservatives in multidose products", written by Dr Dave Elder, Past-Chairman of the JPAG Committee Download the article
Friday 3rd November 2017

Mutagenic impurities
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Mutagenic impurities", co-written by Dr Dave Elder, Past-Chairman of the JPAG Committee. Download the article
Tuesday 19th September 2017

Extractables and leachables
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Extractables and leachables", written by Dr Dave Elder, Past-Chairman of the JPAG Committee Download the article
Tuesday 19th September 2017

Continuous manufacturing: regulatory and quality assurance challenges
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Continuous manufacturing: regulatory and quality assurance challenges ", co-written by Dr Dave Elder, Past-Chairman of the JPAG Committee and Stephen Tindal and Ronak Savla, Catalent Pharma Solutions Download the article

If you found this article interesting, you should consider attending the JPAG event on continuous manufacturing, to be held on Thursday 11 March 2018 at the RSC, London.
Monday 11th September 2017

Good Manufacturing Practice and mutual recognition
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled Good Manufacturing Practice and mutual recognition ", written by Dr Dave Elder, Past-Chairman of the JPAG Committee. Download the article
Monday 11th September 2017

ICH M9: BCS-based biowaivers
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "ICH M9: BCS-based biowaivers", written by Dr Dave Elder, Chairman of the JPAG Committee. Download the article
Monday 27th February 2017

Student Bursary Award
A JPAG Student Bursary Award was made to Riznam Ahmed, University College Cork, to provide travel funds to allow him to attend the symposium on Dissolution testing; current and future considerations.
Mr Ahmed presented a poster on "Broadband acoustic resonance spectroscopy; a novel at-line Process Analytical Technology tool for the analysis of lubricated blends / tablets" at the JPAG /OrBiTo symposium which was held at the RSC on Thursday 9th February 2017.
The symposium attracted an audience of 80 delegates.
Saturday 11th February 2017

More efficient management of post approval change control
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "More efficient management of post approval change control", written by Dr Dave Elder, Chairman of the JPAG Committee. Download the article
Sunday 18th December 2016

Excipient quality and supplier inter-changeability
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Excipient quality and supplier inter-changeability", written by Martin Kuentz, University of Applied Sciences and Arts Northwestern Switzerland, and Dr Dave Elder, Chairman of the JPAG Committee. Download the article
Saturday 29th October 2016

Interpreting ICH s evolving residual solvents guideline
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled “Interpreting ICH s evolving residual solvents guideline”, written by Dr Dave Elder, Chairman of the JPAG Committee. Download the article
Saturday 29th October 2016

Modern pharmaceutical manufacturing
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Modern pharmaceutical manufacturing" written by Dr Dave Elder, Chairman of the JPAG Committee. Download the article
Friday 28th October 2016

The 2016 Geoffrey Phillips Analytical Science Award
Mr Husain Naqi, University of Bath, was awarded the Geoffrey Phillips Analytical Science Award 2016 for the best podium presentation at the APS Conference on Monday 5th September, held at the University of Strathclyde.
The paper presented by Husain was on Pharmaceutical analysis of seized ethylone–ecstasy mixtures.
Husain will receive a bursary of up to 1000 pounds to attend a conference of his choice on a relevant topic.
Monday 12th September 2016

EPR health-based exposure limits for cleaning qualification
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "New regulatory strategies to address un-met clinical needs" written by Dr Dave Elder, Chairman of the JPAG Committee. Download the article
Friday 9th September 2016

Biosimilars: future prospects
Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs), are playing an increasingly
important role in global healthcare. It was recently reported that mAB therapeutics sell for over $50 billion1 globally.
However, one of the major downsides of biological therapeutics is their significantly greater costs compared with small
molecule drugs, which puts an increased burden on global health services.
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Biosimilars: future prospectss" written by Dr Dave Elder, Chairman of the JPAG Committee. Download the article
Friday 1st July 2016

New regulatory strategies to address un-met clinical needs
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "New regulatory strategies to address un-met clinical needs" written by Dr Dave Elder, Chairman of the JPAG Committee and GSK. Download the article
Thursday 12th May 2016

The evolving pharmacopoeia
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "The evolving pharmacopoeia" written by Dr Dave Elder, Chairman of the JPAG Committee and GSK. Download the article
Monday 29th February 2016

Dissolution testing in the modern world
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Dissolution testing in the modern world?" written by Juliet Symonds, GSK and Dr Dave Elder, Chairman of the JPAG Committee and GSK. Download the article
Monday 29th February 2016

Use of the purge tool in assessing mutagenic impurities
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Importation testing: an unnecessary burden on industry?" written by Dr Dave Elder, Chairman of the JPAG Committee and GSK. Download the article
Wednesday 23rd December 2015

An overview of process analytical control
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Importation testing: an unnecessary burden on industry?" written by Dr Dave Elder, Chairman of the JPAG Committee and GSK. Download the article
Wednesday 23rd December 2015

Importation testing: an unnecessary burden on industry?
Here is the latest article in the series reproduced with permission from the European Pharmaceutical Review. It is entitled "Importation testing: an unnecessary burden on industry?" written by Dr Dave Elder, Chairman of the JPAG Committee and Karl Ennis, GSK. Download the article
Friday 30th October 2015

Computational approaches to mutagenicity assessments of impurities
This article is reproduced with permission from the European Pharmaceutical Review. It is entitled "Computational approaches to mutagenicity assessments of impurities: in silico methods" written by Dr Dave Elder, Chairman of the JPAG Committee.

Download the article
Wednesday 16th September 2015

The importance of good distribution practice
JPAG is pleased to present another article in the series of articles reproduced with permission from the European Pharmaceutical Review.

The article is entitled " The importance of good distribution practice", written by Dr Dave Elder, Chairman of the JPAG Committee. It is reproduced from the August issue of the European Pharmaceutical Review, with permission.

The article is now available.

Download the article

Friday 4th September 2015

Drug shortages are finally being addressed
JPAG is pleased to present another article in the series of articles reproduced from the European Pharmaceutical Review.

The article is entitled "Drug shortages are finally being addressed", written by Dr Dave Elder, Chairman of the JPAG Committee. It is reproduced from the June issue of the European Pharmaceutical Review, with permission.

The article is now available.

Download the article

Friday 21st August 2015

First Postgraduate Student Bursary awarded
The first Bursary Award was made to Terry Chapman to attend the JPAG symposium on 14th May 2015. Here is his report.

My name is Terry Chapman, I am a first year post graduate researcher at the University of Bath where I am investigating in-vitro characterisation of antibody drug conjugates, specifically characterisation during forced degradation. My intention is to learn which the routes through which ADCs degrade and how that degradation can be monitored. Correlation between multiple physicochemical and biological methods could reveal which techniques are important to use. This will lay the foundation for establishing stability studies for ADCs, increasing the accessibility of these fantastic but expensive therapeutics.

I recently attended the JPAG-DMDG symposium on Antibody drug conjugates: analytical efforts and expectations. I thoroughly enjoyed the day, which was well thought out and exceeded my expectations, having attended many events by other organisations in the past. The quality of the presentations and speakers ability to answer questions was good, while the presentation content did overlap it helped ensure important points where not missed. Even better was the candour of speakers and attendants during breaks where I had many engaging conversations with true experts in the field of ADC characterisation.
Additionally I was the first recipient of a JPAG-funded Postgraduate Student Bursary to help students cover travel costs and attend these events without paying a registration fee.
The venue, the Royal Society of Chemistry, was appropriate for the day, with good transport links and catering facilities.
Overall JPAG organised a fantastic day, and I highly recommend their meetings to other students and encourage them to apply for a Postgraduate Student Bursary.
Sunday 17th May 2015

In-depth focus; LC-MS roundtable
Here is a summary of a recent roundtable discussion on LC-MS, reported by Dr Dave Elder, GSK, member of the JPAG Committee. The article is reproduced from the April issue of the European Pharmaceutical Review, with permission. The article is now available. Download the article
Monday 27th April 2015

Precompetitive collaborations in the pharmaceutical industry
Here is the second in the series of critical views for 2015, helping you keep up to date with current developments in the pharmaceutical industry. Pre-competitive collaboration, written by Dr Dave Elder, GSK, Chairman of the JPAG Committee. The article is reproduced from the April issue of the European Pharmaceutical Review, with permission. The article is now available. Download the article
Monday 27th April 2015

Stability challenges
Here is the report from the Regulatory Rapporteur of the JPAG symposium on "Stability challenges" held in December 2014. The article is reproduced from the May issue with the permission of TOPRA. The article is now available. Download the article ",
Thursday 23rd April 2015

The cost of drug counterfeiting
Here is the first in the series of critical views for 2015, helping you keep up to date with current developments in the pharmaceutical industry. "The cost of drug counterfeiting", written by Dr Dave Elder, GSK, member of the JPAG Committee. The article is reproduced from the February issue of the European Pharmaceutical Review, with permission. The article is now available. Download the article ",
Thursday 26th February 2015

Postgraduate student bursaries
Are you a postgraduate researcher in pharmaceutical or chemical analysis?
If so, did you know that you can now apply for a bursary which provides complimentary registration and assistance with travel costs to attend a JPAG meeting?
Under this new scheme, JPAG is offering FIVE bursaries for each of the JPAG symposia held in 2015.
During the meeting you will have the opportunity to chat with other like-minded scientists, including speakers and JPAG committee members.
To apply, please send a brief statement on why you wish to attend to Dr Laura Waters (l.waters@hud.ac.uk), indicating which meeting you feel is most appropriate to your area of work and details of what you would like to present. Preference will be given to those who wish to present a poster.
A full list of future meetings can be found at www.jpag.org/

The bursaries are open to full-time postgraduate students (MSc and PhD students) registered at a school of pharmacy or chemistry in the United Kingdom.
Winners will receive a complimentary registration to attend a symposium and assistance with travel costs up to a maximum of £100 using the most cost-efficient means of transport. In exceptional circumstances this maximum may be exceeded. However, the applicant must make the request in advance to treasurer@jpag.org and receive specific agreement in writing before making any bookings.
Bursaries are not available to support attendance at joint events that are not organised by JPAG.

Tuesday 3rd February 2015

Cocrystals; defining the opportunity
This is the latest in the series of critical views, helping you keep up to date with current developments in the pharmaceutical industry. "Crytallography: a core science", written by Dr Dave Elder, GSK, member of the JPAG Committee. The article is reproduced from the December issue of the European Pharmaceutical Review, with permission. The article is now available. Download the article
Thursday 8th January 2015

Crytallography: a core science
Here is another in the series of critical views, helping you keep up to date with current developments in the pharmaceutical industry. "Crytallography: a core science", written by Dr Dave Elder, GSK, member of the JPAG Committee. The article is reproduced from the September issue of the European Pharmaceutical Review, with permission. The article is now available. Download the article
Tuesday 11th November 2014

Can HPLC methods really be considered quality-critical tests?
Helping you keep up to date with current developments in the pharmaceutical industry. "Can HPLC methods really be considered quality-critical tests?", written by Dr Dave Elder, GSK, member of the JPAG Committee. The article is reproduced from the August issue of the European Pharmaceutical Review, with permission. The article is now available. Download the article
Monday 15th September 2014

Pharmaceutical equivalence, therapeutic equivalence and the role of..
JPAG presents another in a series what has become a regular feature on this page.

The article is entitled "Pharmaceutical equivalence, therapeutic equivalence and the role of analytical science", written by Dr Dave Elder, GlaxoSmithKline, member of the JPAG Committee. and Richard Kaye, Senior Investigator, Pharmaceutical Development, R&D, GlaxoSmithKline

It is reproduced from the September 2014 issue of Regulatory Rapporteur published by TOPRA, with permission.

The article is now available. Download the article
Wednesday 20th August 2014

What does quality mean to you?
JPAG presents the latest in a series what has become a regular feature on this page, helping you keep up to date with current developments in the pharmaceutical industry. "What does quality mean to you?", written by Dr Dave Elder, GSK, member of the JPAG Committee. The article is reproduced from the June issue of the European Pharmaceutical Review, with permission. The article is now available. Download the article
Friday 4th July 2014

Is risk in the eyes of the beholder?
JPAG presents the latest in a series what has become a regular feature on this page, helping you keep up to date with current developments in the pharmaceutical industry.
"Is risk in the eyes of the beholder?", written by Dr Dave Elder, GSK, member of the JPAG Committee.
The article is reproduced from the April issue of the European Pharmaceutical Review, with permission.
The article is now available. Download the article
Tuesday 6th May 2014

ICH M7 Mutagenic impurities: a critical evaluation
JPAG presents the first article in 2014 in the series which is now a regular feature on this page. The aim is to you keep up to date with current developments in the pharmaceutical industry.

"ICH M7 Mutagenic impurities: a critical evaluation" is written by Dr Dave Elder, GSK, member of the JPAG Committee.

The article is reproduced from the February issue of the European Pharmaceutical Review, with permission.

The article is now available. Download the article
Monday 24th February 2014

ICH Q6A - Specifications: Test procedures and acceptance criteria ...
JPAG presents the latest in a series what has become a regular feature on this page, helping you keep up to date with current developments in the pharmaceutical industry.

ICH Q6A - Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances", written by Dr Dave Elder, GSK, member of the JPAG Committee.

The article is reproduced from the December issue of the European Pharmaceutical Review, with permission.

The article is now available. Download the article
Tuesday 7th January 2014

ICHQ3D Metal Impurities. A critical evaluation
JPAG presents the fourth in a series what has become a regular feature on this page.

The article is entitled "ICHQ3D Metal Impurities. A critical evaluation", written by Dr Andy Teasdale, AZ and Chairman of JPAG, and Dr Dave Elder, GSK, member of the JPAG Committee.

It is reproduced from the October issue of the European Pharmaceutical Review, with permission.

The article is now available. Download the article
Saturday 2nd November 2013

ICHQ2(R1) Validation of analytical procedures: challenges .......
JPAG presents the third in a series that will become a regular feature on this page.

The article is entitled "ICHQ2(R1) Validation of analytical procedures: challenges and opportunities", written by Dr Dave Elder, GSK, member of the JPAG Committee. It is reproduced from the August issue of the European Pharmaceutical Review, with permission.

The article is now available.

Download the article

Monday 9th September 2013

ICHQ2 (R1) Validation of analytical procedure: challenges and ....
The latest issue of European Pharmaceutical Review has an article on ICHQ2 (R1) Validation of analytical procedure: challenges and opportunities. This article will appear soon on the JPAG website. Members of JPAG can sign up to receive complimentary copies of E.P.R., another membership benefit.
Thursday 22nd August 2013

New guidelines for breakmarks on tablets
JPAG is pleased to present the second in a series that will become a regular feature on this page.

The article is entitled "New guidelines for breakmarks on tablets", written by Professor Tony Moffat, member of the JPAG Committee. It is reproduced from the May issue of the European Pharmaceutical Review, with permission.

The article refers to FDA guidance on the acceptance criteria for content uniformity of split tablets.

The article is now available.

Download the article

Wednesday 10th July 2013

Towards Global Stability Protocols: A Decade of Lost Opportunities?
This article is the first in a series that will be appearing on this page.

The article is entitled "Towards Global Stability Protocols: A Decade of Lost Opportunities?", written by Dr Dave Elder, member of the JPAG Committee. It is reproduced from the April issue of the European Pharmaceutical Review, with permission.

JPAG is organising events about stability testing during the next 12 months - please watch the website for further details.

The article is now available.

Download the article

Thursday 23rd May 2013


Geoffrey Phillips Analytical Science Award


Alessandra D'Angelo, University of Greenwich, receiving the 2017 Geoffrey Phillips Analytical Science Award from Dr Dave Elder, Past-Chairman of JPAG.



Student Bursary Award winner
Rizwan Ahmed, University College, Cork



Geoffrey Phillips Analytical Science Award

For details on how you might be a future winner of the Geoffrey Phillips Analytical Science Award and perhaps travel to an international conference, please go to the INFO page.






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