IPEC e-newsletter - Excipients Insight November 2017 - 22-11-17



Welcome to Excipients Insight November 2017.

As this is the penultimate edition of our newsletter in 2017, it’s nice to be able to share with you here the outcomes of much hard work on your part and of course, our sister organisations. The introduction of the Quality Agreement and Co-Processed Excipients Guides really contribute to our mission of spreading the word on current excipient issues to assist you in your compliance and business efforts. And this is just the tip of the iceberg as to what’s in line for 2018. We have to keep our guides current and relevant, so plans are being developed to improve GMP, GDP Audit and Excipient Information Package Guides at the IPEC Federation level. Excuse me for repeating this, but I don’t think I can ever say it enough … please contact us if you’re interested in participating in any of these teams! And for those who have been involved already, thanks again to you and your companies for the vital resources that enables us to do all of this great work.

To complement the introduction of the Quality Agreements Guide you can read here about our accompanying webinar. It’s a great opportunity to hear first-hand from a true expert, how good quality documents of this kind can make a difference. And I’d like to mention also that the issue of the Co-processed Excipients handbook is very timely. The second draft of Pharmeuropa’s monograph for these types of materials is out for consultation. We’re currently compiling comments from our member so if you missed out when it was distributed initially and think you’d like to express your thoughts on it, please get in touch with the Secretariat for more details.

This edition presents IPEC Europe’s first infographic, to add to our toolbox to reach out to the broader community involved with or to those who need to know more about excipients. As the article says, this is a ’first’ for us so we’d love to get your feedback on how successful we’ve been in getting the message across, particularly from any colleagues who may not be so familiar with excipients as yourselves.

And finally, one more plea if I may. Recently we have shared across the membership requests from both the pharmacopoeias of China and US for companies to submit data to help them with their monograph development work plans (for new monographs and elemental impurities respectively.) While this does require effort on your company’s part, ultimately it should lead to the establishment of better quality monographs, better representing global supply which ultimately, better for patients. So please consider participating in such programmes.

In the next issue, we’ll have reports from our committees and also the Board which holds its final meeting for this year on 28 November … if you have any issues which you’d like to raise with us, we’re happy to hear from you!

Meanwhile, pleasant reading!


Frithjof Holtz

IPEC Europe chair



IPEC-Americas and IPEC Europe publish Co-Processed Excipient Guide

IPEC-Americas and IPEC Europe have jointly published the Co-Processed Excipient Guide for excipient makers and users. The new guide offers best practices toward co-processed excipient development, manufacture and use, and provides support to both co-processed excipient manufacturers and users.

A co-processed excipient is a combination of two or more compendial or non-compendial excipients designed to physically modify their properties in a manner not achievable by simple physical mixing, and without significant chemical change.

Co-processed excipient users are responsible for assuring fitness for purpose and that the co-processed excipient and its components are manufactured to acceptable good manufacturing practice (GMP) standards. The guide facilitates communication between excipient users and suppliers regarding the safety information required for regulatory filing for a product containing a novel co-processed excipient.

The Guide is available for download at no charge on the IPEC Europe website at www.ipec-europe.org or for IPEC-Americas members and non-members by visiting www.ipecamericas.org (after registering).

A free webinar that highlights guide content will be hosted by IPEC-Americas on Friday, December 15, 2017 from 11:00 am – 12:00 pm EST. For more information about the webinar, click here: http://ipecamericas.org/excipient-learning-lab/webinars/co-processed-excipient-guide-overview



IPEC Europe webinar - Quality Agreement and Templates Guide 2017

IPEC Europe is pleased to announce its new webinar on 23 November 2017, 15:00-16:00 CET.

The webinar will present the Quality Agreement Guide and Template(s) for Pharmaceutical Excipients 2017 that will be published and available to download free-of-charge on Monday 13 November.

Register and receive best practices and guidance on the content of an excipient Quality Agreement. Excipient suppliers will be introduced to the process of preparing their own Quality Agreement Template according to company standards, as the template format is intended to be flexible.

The concepts of what should be in such Quality Agreements have been explained in the 2009 IPEC Quality Agreement Guide and Templates. However, with new regulatory requirements and ever more complex supply chains, this Guide had been revised by a team of IPEC experts to provide practical and detailed guidance on how to meet all of these challenges. This new version considers EXCiPACT and ANSI certification standards, which are increasingly recognised as a means of demonstrating that suppliers operate in conformance with excipient GMP. And very significantly, to help ensure both final customers’ and manufacturers’ needs are addressed when the customer buys from a distributor, this revision introduces the innovative concept of Manufacturer’s Quality Statement template.

This webinar will serve as a good introduction to those who have recently become engaged in customer/user management and for experienced professionals, a refresher on the latest developments in this important area.

The webinar will be hosted by Astrid Stockrahm-Uhling of DFE Pharma. Astrid has significant experience in this field and also led the task force responsible for the revision of the 2009 Quality Agreement Guide. After Astrid reviews current perspectives on this topic, participants can engage in a live interactive session adding to the learning experience!

Registration fee

  • IPEC Europe members: €50 excl. VAT (21%)
  • Non-Members: €75 excl. VAT (21%)

More details and registration here.



IPEC Europe debuts first infographic

Within the IPEC Europe Agenda 2020, stakeholder collaboration and communication are pivotal in extending our outreach to our members and the broader excipient community.

In this direction, we developed a new communication tool collectively with European Fine Chemicals Group (EFCG) to address our key stakeholders and inform them about the added value of the upstream components of the medicines’ supply chain, including active ingredients and, of course, pharmaceutical excipients.

As a result, we are glad to present the first infographic in IPEC Europe’s history, to help us engage in a clear and simple manner with key stakeholders, that may not be so aware of excipients and their importance.

What are you waiting for? Click here for the full version of our new infographic on ‘The Value of Excipients’!



Mark your calendar! IPEC Europe 2018 Excipients Forum

Interested to know the latest development relating to excipients? Looking for an event to share experience and network?

Don't miss the IPEC Europe 2018 Annual Excipients Forum on 1 February at the Grand Hotel of Bordeaux!

The programme will cover pharmacopeias’ topics, latest regulatory developments in China, co-processed excipients, Quality by Design and so much more! More information here.
Make sure to register by clicking here!

IPEC Europe negotiated a very attractive rate at the Forum hotel, but the offer is limited in time, so do not wait and book as soon as possible.

We look forward to welcoming you in Bordeaux!



IPEC Europe calendar

Group Q3 2017
IPEC Europe Board 28 November - Brussels
GDP Committee 21-22 November
Pharmacopoeial Review & Harmonisation TBC
Quality/Regulatory Affairs 16 November - Darmstadt



EMA makes decision on new location - it's Amsterdam!

As this edition of Excipients Insight went to press, the decision was made on the new location for the European Medicines Agency (EMA), with Amsterdam winning out over Milan by the narrowest of margins - picking the name out of a hat!

The first two voting rounds went to the Milan, but its Dutch rival won out in the third and decisive round by sheer chance after the EU ministers' final vote was tied. The city was also the most popular location among EMA staffers in a recent survey. The agency will relocate after the UK leaves the EU.

Ahead of the verdict, the agency issued a statement noting that it has less than 17 months to conclude its move and take up operations in the new host city by the end of March 2019. Copenhagen and Bratislava were also eliminated from the final shortlist.

“Moving a large organisation such as EMA to a new location is a challenging undertaking under any circumstances. It is made even more complex by the ambitious timetable determined by the withdrawal of the UK from the EU,” said the EMA in a statement.

The Council of the European Union has published a Q&A document on the main features of agencies’ relocation ahead of the final decision and announcement on 20 November.

Interestingly, there will be no permanent record of how Member States voted in the relocation process of the EMA and European Banking Authority (EBA), which is also leaving the UK as a result of Brexit. The decision to destroy ballot papers follows an agreement by EU leaders  that votes should be cast by secret vote.



Changes to CEP applications due in January

From 1 January, 2018, new Certificate of Suitability (CEO) applications to the European Directorate for the Quality of Medicines & Healthcare (EDQM) must be filed in electronic common technical document (eCTD) format.

On the same date, the EDQM will stop accepting PDF submissions for revisions and renewal applications. Therefore, all such submissions need to be either in NeeS (Non-eCTD electronic Submission) or eCTD format, says the regulator. There are a couple of exceptions - for TSE only submissions PDF will continue to be accepted, while for substances for veterinary use only, VNeeS (Veterinary Non-eCTD electronic Submission) will also be acceptable.

Last year, the EDQM noted that the number of electronic submissions has increased regularly, since it started encouraging their use in 2007, but noted that paper applications still represented about 10% of applications received.  The bulk were being received in PDF format, with eCTD accounting for around 20% of the total.



PDG publishes its report on September meeting

A report on the Pharmacopoeial Discussion Group (PDG) meeting which took place on September 12-13 is now available on the website of the European Directorate for the Quality of Medicines & Healthcare (EDQM).

Among the highlights from the meeting are some significant changes to the PDG work structure, including: eliminating two stages of PDG harmonization process to streamline and reduce the level of complexity; restructuring the meeting format to engage more effectively at the technical level with regards to resolving issues on specific topics; and maintaining a twice-yearly meeting frequency with a focus on strategic direction setting.

Under the new structure, harmonization of several PDG topics will be continued in other collaborative venues, such as bilateral discussion or adopt/adapt mechanisms as mentioned in the Good Pharmacopoeial Practices (GPhP), said the EDQM in a statement.

The report on the meeting can be downloaded here.



EU-US mutual recognition of inspections "a testimony to trust"

A mutual recognition agreement between the EU and the US to recognise inspections of drug manufacturing sites conducted in their respective territories came into effect on 1 November.

The new agreement – which updates an earlier agreement from 1998 – allows for recognition of inspection outcomes in the respective territories, and hence more efficient use of inspection expertise and resources, and takes the MRA into its operational phase.

THE FDA has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements, namely: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK. The remaining inspectorates will continue to be assessed until 15 July 2019.

“We need to think globally and work strategically with partners from around the world to make best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured,” explained Professor Guido Rasi, Executive Director of the European Medicines Agency (EMA).

“I am very pleased that we can now add the mutual recognition agreement with the FDA to our six existing agreements with third-country authorities,” he added. Currently, EMA has MRAs in place with Switzerland, Australia, New Zealand and Japan, as well as Canada and Israel (with some exclusions).

The EMA notes that around 40% of finished medicines marketed in the EU come from overseas, while 80% of the manufacturers of active pharmaceutical ingredients for medicines available in the EU are located outside the Union.



Brief: CVMP drafts implementation guide for elemental impurities

The EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has drafted an implementation guideline that is intended to help regulators elaborate guidance on the appropriate approach for an elemental impurities risk assessment for veterinary medicines.

Regulatory action is not expected at this time and routine submission of risk assessments via variations, or otherwise, is not envisaged. Further guidance of expected regulatory actions will be elaborated and published in due course, says the document.



Recommended reading

Commodity Inactive Ingredients? Not so Fungible, not so Inactive

It is now over a decade since Hogan predicted diversification of the excipient industry into “two groups, one focusing on high-tech excipients with greater functionality and high prices - developed in partnership with drug companies and in a manner akin to an active pharmaceutical ingredient - and a commodity sector.” He described the commodity sector as the “pharmaceutical divisions of companies whose main business is outside of the pharmaceutical sector,” with competition on price and service.

CPhI annual report (requires download)

Raman spectroscopy as a PAT for pharmaceutical blending: advantages and disadvantages

Raman spectroscopy has been positively evaluated as a tool for the in-line and real-time monitoring of powder blending processes and it has been proved to be effective in the determination of the endpoint of the mixing, showing its potential role as process analytical technology (PAT).

Journal of Pharmaceutical and Biomedical Analysis

Pharmaceutical supply chain security risk assessment for shipping lanes

With the publication of the European Good Distribution Practices (GDP) guideline, to better protect the pharmaceutical supply chain – referencing EMA Guidelines in 2013 – all actors in the pharmaceutical supply chain are obliged to perform a full review of all associated Quality Systems to determine current compliance status, as well as address gaps, thus ensuring compliance in accordance with the guideline.


Growing demand for taste-masking technologies

Taste masking increases drug acceptability and medication adherence in paediatric, geriatric, and other special patient populations.


Brave new factories

Cell therapy successes have got the industry talking, but the future of the field now lies in the hands of manufacturing specialists who must develop factories capable of meeting high demands.

The Medicine Maker



Download IPEC guides

All of IPEC's guides are available for free download via our website. Follow the links below to make your selection. 

  • 2017 IPEC Quality Agreement Guide
    Download PDF
  • 2017 The IPEC Co-processed Excipient Guide
    Download PDF
  • 2017 The Joint IPEC-PQG Good Manufacturing Practices Guideline - Updated version
    Download PDF
  • 2017 The IPEC Good Distribution Practices Guideline - Updated version
    Download PDF
  • 2016 IPEC Europe 'How-To' document on Risk Assessment
    Download PDF
  • 2014 The IPEC Glossary of Terms
    Download PDF
  • 2014 The IPEC Significant Change Guide: Third revision
    Download PDF
  • 2013 The IPEC Certificate of Analysis Guide
    Download PDF
  • 2012 IPEC Excipient Information Package (EIP): Template & User guide
    Download Word or PDF
  • 2011 The IPEC Good Distribution Practices Audit Guideline
    Download Word or PDF
  • 2010 The IPEC Excipient Stability Program Guide
    Download PDF
  • 2009 IPEC Quality Agreement Guide & Template
    Download Word or PDF
  • 2008 Qualification of Excipients for Pharmaceutical Use Download (Word) or (PDF)
    Download Word or PDF
  • 2008 The IPEC-PQG GMP Audit Guideline
    Download Word or PDF
  • 2008 The IPEC GDP Audit Guideline
    Download Word or PDF



Events calendar

Here is a round-up of forthcoming events of interest to suppliers and users of excipients. Please let the IPEC Europe Secretariat know if we've missed one.

2017 ISPE UK Annual Conference
Stratford-upon-Avon, UK - 30 November, 2017
More information here.

2018 IPEC Europe Annual Excipients Forum
Bordeaux, France - 1 February 2018
More information here.

11th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
Granada, Spain - 19-22 March, 2018
More information here.

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