IPEC e-newsletter - Excipients Insight April 2017 - 30-04-17



Dear colleagues,

As you will read in this edition of Excipients Insight, this will be my last editorial as Chair of our association. While the interview with me - which can be found here - allowed me to reflect on the past and what I hope will be future achievements, I want to take another opportunity to express my gratitude to our members. It can never be said enough times the benefits we gain from your efforts and inputs and on which, ultimately, the association relies on so heavily.

Even though we are building a stronger infrastructure and expanding our network of individuals and associations with which we collaborate, it is your input that makes the difference. Being able to reflect the realities of this great intangible which we call ‘the excipient Industry’ in our outputs and gain their acceptance, is one of our greatest successes. So please forgive me then for making one last call to you and colleagues in your organisations to engage in our projects. We can never have enough help - ‘the more the merrier’ as the saying goes! The highlights of this month’s Board meeting show at a high level our current areas of focus. So if you would like any more details, please don’t hesitate to contact our Secretariat for more information and get involved!

Meanwhile there is much of interest in this month’s features and it’s always pleasing to see that IPEC Europe is reaching out in our efforts to share knowledge on excipient-related topics and hopefully at the same time recruit new members.  This edition also reports feedback on what the regulators see in their various monitoring programmes. Specifically, with the UK MHRA’s substantive inspection deficiencies report, I would note wherever you are in the excipient supply chain, these make a good reference for internal self-inspections. Particularly, the deficiencies on material management, data integrity, technical agreements and outsourced should be of interest and very aligned with IPEC activities.

So, while I bid you a fond farewell of course, I will still be an active member of the Board and IPEC Europe in the role of the Vice Chair, supporting the transition of the leadership to Frithjof Holtz. I extend my thanks to him for taking up this challenge and as no doubt you do, and wish him every success!

Frank Milek



Interview: Departing chair Frank Milek looks back on past five years

After five years at the helm, IPEC Europe chair Frank Milek is stepping down, to be succeeded by the current vice chair, Frithjof Holtz.

In this last edition of Excipients Insight to be published during his tenure, we asked Frank to look back on his time leading the association and give some pointers for the future.

EI: When you took over as chair of IPEC Europe in 2012 – what did you see as the biggest challenges for the association, and what was your vision for taking it forward?

FM: When I took over the chairmanship the primary objective was to restructure the operations of the association. At the time it was registered in France, with administrative support from an external provider based in Brussels, and IPEC Europe relied heavily on volunteers from the membership. One of my main goals was to move the registration to Brussels, to benefit from close proximity to EU policymaking mechanisms and also to tap into some financial advantages unavailable in France. It was important to me that IPEC Europe should have its own office and secretariat, staffed with its own dedicated personnel. It is worse noting also that six of the eight IPEC Europe board members changed as I took over as chair. That presented some challenges in terms of continuity, but also gave us the opportunity to start fresh.

EI: What do you see as the most important changes that have taken place in the operating environment for excipient suppliers and users in the intervening years, and how successful has IPEC Europe been in responding to those changes?

FM: We had some significant regulatory changes in terms of risk-assessment and GMP for excipients – which is now required –as well as some changes relating to the relationship between excipient suppliers and users, such as a requirement for formal quality agreements. These have been a challenge for both suppliers and users.  I believe however that IPEC Europe responded effectively to that through our strong support of the EXCiPACT standard and third-party certification system – which allows better qualification of excipient suppliers and save resources on both sides – and of course A huge amount of work has gone into updating our guidelines to facilitate compliance. Revisions of the IPEC-PQG GMP Guide and GDP Guide, which were first prepared in 2006, are just about to be published, and we have also published recently the Significant Change Guide, the Quality Agreement Guide and a How-To Document for Risk assessment. Of course, that body of work drew on the excellent and close cooperation between IPEC Europe, our sister PECs and the IPEC Federation. These fruitful working relationships have also helped tackle another big challenge facing the industry over the last few years – globalization - which has added to the array of standards and regulations affecting excipients.

EI: How would you describe your legacy at the association, and what improvements could still be made?

FM: From my perspective, the biggest achievement is to leave my successor with an association that in part because of the structural changes – now registered and location in Belgium and with a growing secretariat staff – is better positioned to monitor and react quickly to new developments affecting pharmaceutical excipients. Along with two full-time employees to provide administrative and organisational support, IPEC Europe can now draw upon the expertise of Adrian Bone, senior advisor to the association, so that the projects undertaken by the association no longer all have to be done only by volunteers.  I really wanted to put all these changes into effect before stepping down, and that is one reason why I have served for five years – one of the longest tenures of any IPEC Europe chair. Expanding the network of experts such as Adrian remains a priority, to assist volunteers so that more practical work can be carried out by the association and it can respond even faster to regulatory challenges when required. It would also be desirable to increase cooperation with other stakeholders – for example other industry associations like APIC, EFCG and EFPIA – raise our visibility with regulatory authorities and also embrace newer communication channels such as social media.

EI: As IPEC Europe embarks on a new era, do you have any words for the incoming chair of the association?

I am delighted that Frithjof will be taking over as chair of IPEC Europe, as he has many years of experience as a board member of the association and has been intimately involved in setting and working on our objectives, including our recently-drafted Agenda 2020. I know that he is committed to continuing the invaluable work of IPEC Europe and I have no doubt that he will receive the same excellent level of support from the rest of the board and the membership that I have enjoyed over the last five years.



Report on first 2017 IPEC Europe Board meeting

At the beginning of the month, The IPEC Europe Board held its first face-to-face meeting of 2017.  After the presentation made at the Annual General Meeting in Monte Carlo, it's the time when the real work starts and plans are refined and actions taken. You may recall that the Board has established its Agenda 2020 and the accompanying Roadmap defining the activities required to take IPEC Europe there. The Roadmap identifies eight pathways, and the ownership of each is assigned to Board members.

A significant amount of time was dedicated to reporting progress and potential barriers which need to be removed in order to achieve the goals targeted for this year. It is good to note particularly that in the areas of communication and knowledge sharing, great steps have already been taken. The website redesign is underway with a 'go live' date aimed at Q3 and very soon webinar events will be launched to align with the publication of the recently revised GMP and GDP Guides.

IPEC Europe, in a bid to enhance awareness of our endeavours is scheduled to exhibit and/or present at several events including AFI 57e Simposio (Rimini, June), ExcipientFest Asia (Beijing, July), PowTech (Nuremberg, September),and the APV/IPEC Europe Conference (Berlin, September). Of course it is hoped that these activities will help to support member recruitment which is a key strategic initiative for 2017.

Another key focus area where things are starting to happen is stakeholder collaboration. Following the signing of a Memorandum of Understanding with EFCG in 2016, work has begun to raise awareness at the higher levels in the EU of the importance and contribution of APIs and pharmaceutical excipients in the supply of medicines. While a series of tools to enable us to communicate this message will be created, IPEC Europe's first step is to develop an infographic related to excipients, their development, supply and use, in parallel with EFCG for APIs.   

As the Pharmacopoeial Review & Harmonisation Committee is currently in a state of flux while new leaders are sought, consideration was given as to how this important group could be reconfigured to improve its effectiveness in supporting the harmonisation agenda. With the support of the Board, the PR&HC did meet on 25 April, a report of which will be included in the May edition of Excipients Insight.   

Finally, the Election of Officers following the AGM took place as is required by our Articles of Association.

IPEC Federation update

IPEC Europe Board agendas routinely include an update on the work plan of the IPEC Federation which on this occasion was delivered by its President, Dr Patricia Rafidison.  Patricia reported that the Federation is keen to make its undertakings ever more transparent to the broader IPEC community in 2017 by attending events held by the IPEC sister associations. Key to this is the release of position papers on very important global issues such as data integrity and atypical actives, as they relate to excipients. It is hoped a future edition of Excipients Insight, will include an interview with Patricia where these and other Federation issues can be explored.



New IPEC-PQG GMP guide set for publication shortly

IPEC Europe's GMP Revision Task Force has completed an updated version of the IPEC-PQG GMP Guide, bringing the document fully in line with the latest thinking on Good Manufacturing Practice requirements for pharmaceutical excipients. The new guide should be officially published and available shortly.

The quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate GMP principles to excipients is essential.

The new 2017 version of the IPEC-PQG GMP Guide replaces the 2006 edition. While the fundamental principles of GMP have not changed in the intervening period, there have been important changes in the way adherence to GMP should be achieved.

In particular, there is an increased regulatory emphasis on risk-assessment. The EU Directive on Falsified Medicines (2011/62/EU) lays out a requirement for pharmaceutical manufacturers to carry out a risk-assessment for excipients used in pharmaceutical products to determine the appropriate level of GMP used to produce them. In turn, that led to the publication of the EU Guidelines on risk assessment for excipients (2015/C 95/02) which came into force on 21 March 2016. This risk assessment thinking should also be applied by Excipient manufacturers as they implement GMP.

The guide also needed to be updated to take into account the EXCiPACT standard, against which excipient suppliers can be certified to provide assurance that they are operating in conformance with excipient GMP. Third-party certification against EXCiPACT is increasingly being adopted by excipient producers and sought by pharmaceutical manufacturers.

"We needed to bring the guidance up to date with new requirements such as risk assessment, and also make sure that it is fully aligned with the EXCiPACT standard," said Kevin McGlue, IPEC Europe's Revision Task Force Leader for the new guide. "Users of the new guide will be brought fully up-to-date with the latest GMP thinking for excipients."

Other updates to the guide include the provision of greater detail on documentation – taking into account the shift to from paper to electronic record-keeping over the last decade – as well as refined and expanded guidance about corrective actions, sample retention, packaging etc.

The guide is an important accompaniment to EXCiPACT's international standard as well as NSF/IPEC/ANSI 363-2014 standard in the US, according to McGlue. It provides guidance for groups just starting with GMP, as well as for those who may not want to go down the certification route, and also gives initial assistance for those just starting to think about standards and certification in the context of pharmaceutical excipients.



GDP Committee delivers new IPEC Federation GDP guide

IPEC Europe's GDP committee has completed its revision of the Good Distribution Practice (GDP) Guide which will now be published as an official IPEC Federation document, as the 2017 edition.

The original guide – published in 2006 - was in need of updating to bring it into conformity with current practices and regulatory requirements and is now fully aligned with the World Health Organization's Good Trade and Distribution Practices (GTDP) for Pharmaceutical Starting Materials, document, which came onto effect in 2016.

"The original guide was based on WHO GTDP Guide published in 2003, but this document itself was not under consideration for update by the WHO until approached by IPEC Europe," said Eckart Kraemer, who chairs the GDP committee.

The new version will help excipient suppliers make their systems more robust in order to satisfy the expectations of customers and meet regulatory requirements, while excipient users will benefit from the many additions and clarifications made to the original text, he added.

Among the key changes to the guide is the inclusion of quality risk management principles, which were previously missing but have become standard in several industries, as well as specific and more detailed guidance on supplier management to help ensure authenticity, traceability and security of the supply chain.

Other important amendments include clarification of the need for an independent quality unit, extension of the CAPA requirements to include preventive actions and verification of effectiveness, detailing the practices that should be implemented to avoid cross-contamination and mix-up and clarifying that carriers used for transportation should be approved according to a written procedure - unless the carrier has been selected by the customer.

Overall, the update has provided greater detail and functionality to the document as a whole, for example by including integrated links to associated documents such as guides and standards, said Kraemer. Examples based on practical experience are provided to facilitate the application of GDP. However, alternative approaches may be acceptable.

Critically, the GDP committee worked with the WHO in developing an update to their document thus allowing the GDP guide to be republished in alignment with the current WHO GTDP document.

Where GMP relevant activities are described, reference to the IPEC-PQG GMP Guide – also just updated (see our article here) – and other publications and standards such as the EXCiPACT GMP and GDP standards (2012) and NSF/IPEC/ANSI 363 have been made in order to maintain consistency.

The guide will be available for free download in the near future.




EXCiPACT is off to a flying start in 2017

EXCiPACT can look back on a very successful start to 2017, marked by a healthy increase in the number of new certificates issued.

In the first quarter of the year, EXCiPACT issued 10 new certificates, a new record for the organization and further evidence that momentum is building behind the use of third-party certification against the EXCiPACT standard.

Even more recently, the Croda Japan K.K. Shiga factory was certified by SGS, one of EXCiPACT's internationally-recognised certification bodies, marking the first time that a certificate has been awarded to a Japanese facility.

The full list of certificates awarded so far this year – in the US, Europe, China, India and Japan - is as follows:

  • Croda Japan Shiga factory in Shiga-Ken, Japan
  • Croda Inc. sites in Mill Hall, Pennsylvania and in New Castle, Delaware
  • Chemische Fabrik Budenheim KG site in Budenheim, Germany,
  • Sudeep Pharma Pvt. Ltd. site in Vadodara, Gujarat
  • Carbagas site in Domdidier, Switzerland
  • Chemfield Cellulose Private Ltd site in Nagpur, India
  • Anhui Sunhere Pharmaceutical Excipients Co. Ltd site in Huainan, Anhere, China
  • Ashland Specialties France site in Alizay, France
  • KLK Emmerich GmbH's site in Düsseldorf, Germany
  • VWR Chemicals, LLC's site in Aurora, Ohio, USA
  • AMRESCO, LLC's site in Solon, Ohio, USA

EXCiPACT President Kevin McGlue said the first quarter performance indicates that the organizations plans are on track, particularly with regard to developing EXCiPACT on the international stage.

He also noted that the consultation period on the revision to the EXCiPACT standard is coming to a close (see our article here) and the project remains on course for the publication of the new version in the third quarter of 2017.

For more information on EXCiPACT certification visit the association's website.



Free webinar on elemental impurities: implementation of ICH Q3D

The ICH Q3D guideline represents a change of paradigm in the control of elemental impurities in medicinal products. In Europe, the guideline has been applicable to new marketing authorisations since June 2016 and will also become mandatory for authorised medicinal products within its scope as of December 2017.

Bearing this in mind, the EDQM will repeat its webinar on 16 May to explain how the implementation of ICH Q3D impacts the following areas:

  • texts of the European Pharmacopoeia
  • the assessment of CEP applications, following the release of the EDQM policy document “Implementation of ICH Q3D in the Certification Procedure” (PA/PH/CEP (16) 23)

The presentation consists of two parts and will cover the following topics:

Part 1 (about 20 min)

  • Implementation of the ICH Q3D in the general monographs and chapters
  • Impact of the ICH Q3D on individual monographs on substances for pharmaceutical use

Part 2 (about 40 min)

  • Overview of the Certification policy: possible scenarios, expectations on content and assessment
  • Case studies
  • Impact of ICH Q3D and the Ph. Eur. policy on existing CEPs, treatment revisions and renewals
  • How to interpret and use the information relating to elemental impurities when mentioned on CEPs

The webinar will be presented by Bruno Spieldenner, Scientific Officer in the European Pharmacopoeia Department and Mr Lennart Seidler, Scientific Officer in the Certification of Substances Department.

More information is available here.



IPEC and EXCiPACT take the stage at Making Pharma

Now in its fourth year, Making Pharmaceuticals moved to a new venue (the Ricoh Arena, Coventry) to accommodate their biggest event yet on 25-26 April. More than 110 exhibitors filled a single exhibition space and more than 80 conference sessions were held in four parallel session over the two-day event.

IPEC Europe/EXCiPACT were jointly represented in the exhibition space and met with a steady stream of interested visitors. IPEC Europe hosted a conference session on 25 April. Following a brief introduction about IPEC Europe (Liz Meehan, Board member) presentations were delivered by UK members on three topics: Quality by Design as applied to pharmaceutical excipients (Kevin Hughes, Colorcon), Co-processed excipients (Liz Meehan, AstraZeneca), Pharmacoepial monographs for excipients (Iain Moore, Croda). This session was attended by around 45 visitors.

In the EXCiPACT conference session on 26 April the presentations covered the following areas: Pharmaceutical excipients, putting the “c” into EXCiPACT cGMP and cGDP (Iain Moore), and EU2015 Guidelines on formalised risk assessment for pharmaceutical excipients, how EXCiPACT Certification can help (Tony Scott, EXCiPACT). This session was attended by around 25 visitors.

Enquires at the booth (hosted by IPEC Europe and EXCiPACT) were modest, but very enlightening: almost all had heard of EXCiPACT and many wanted to know more about it. Of particular note was the fact that this included hospital pharmacies who compounded their own drug products, start up pharmaceutical companies and consultants. Clearly the message about EXCiPACT has reached some surprising parts of the industry! There were many opportunities to introduce all visitors to the booth to IPEC Europe and the IPEC activities.




Excipient learning lab - discounts available!

The Excipient Learning Lab at IPEC-Americas has announced a special IPEC Federation discount for its eLearning courses. The discount applies to members of any regional PEC, even if they are not an IPEC-Americas member.

IPEC-Americas excipient GMP experts have developed on-demand, computer- or mobile device based training on basic excipient GMPs with four online, self-paced courses; one specifically designed for manufacturing supervisors and three for workers in three different plant areas.  A Certificate of Completion is awarded after a knowledge assessment and successful completion of each course, which can be used as a training record for your GMP compliance records. Please note that the training is provided in English.

Level 1 - Excipient GMPs for Manufacturing Workers ($149 per registration, Federation Members)

These courses are specifically intended for manufacturing plant workers in three specific areas (see below) and cover topics including: Introduction to Excipient GMP, Excipient Functionality, Documents and Records, Hygienic Practices, Work Environment, and content specific to each of the plant areas below.

  • Level 1 Excipient GMPs for Manufacturing Workers - Production & Maintenance
  • Level 1 Excipient GMPs for Manufacturing Workers - Laboratory
  • Level 1 Excipient GMPs for Manufacturing Workers - Warehouse/Bulk Handling

Level 2 - Excipient GMPs for Manufacturing Supervisors ($319 per registration, Federation Members)

The NEW Level 2 course expands on the basics of excipient Good Manufacturing Practices (GMPs) with emphasis on the compliance responsibilities of supervisors and hourly and/or "first-line" workers.

More information here.



Last chance for EXCiPACT standards revision consultation

The EXCiPACT Board commissioned a project team to undertake a revision of the EXCiPACT standards to align them to ISO 9001:2015 and ISO/IEC 17021-1:2015 without change or enhancement of any individual requirements, other than to correct for errors in the original publication.

The draft revision has been completed and is now available for public comment via a Review Template, mandatory for the submission of comments. Links to both documents are:

Only comments received by Friday 5 May 2017 - on a correctly completed review template with proposed alternative wording - will be considered.  Any other form of comment or failure to propose alternative wording, or anonymous comment, will be disregarded.



IPEC Europe calendar

Group Q2 2017
IPEC Europe Board 27 June
GDP Committee 24-25 April
Pharmacopoeial Review & Harmonisation 25 April
Quality/Regulatory Affairs 1 June



Pharma leaders call for smooth EMA move post-Brexit

The R&D heads of some of the largest biopharma companies have appealed for a smooth relocation for the European Medicines Agency (EMA), saying that it is imperative that the agency's "world class" regulatory oversight is not undermined.

In an open letter published on the website of the European Federation of Pharmaceutical Industries & Associations (EFPIA), senior R&D figures from 19 multinationals say they fear that pharmacovigilance and safety monitoring activities could be affected if the move from London leads to disruption.

"The system that has been established for the safety monitoring of medicines within Europe is fully reliant on the knowledge and expertise that is incorporated within the EMA and, more specifically, within its seven scientific committees, which are composed of experts sourced from every member state of the EU," say the pharma leaders.

"It is a stark and alarming reality that such fundamental activities would undoubtedly be impeded were the operations of the agency to be disrupted as a result of the UK's exit from the EU," they write. "To put it concisely: in the event of obstruction or failure, Europe possesses no backup option."

Big pharma companies are not the only organizations worried about the fallout of the relocation of the EMA post-Brexit. EMA executive director Prof Guido Rasi has suggested the uncertainty has already resulted in staff departures, while the European Parliament has also called for a rapid decision on a new home for the agency.

At last count, 21 of the 27 post-Brexit member states have pitched to house the EMA, while UK Secretary of State for Exiting the EU – David Davis - has even suggested that it may be possible for the regulatory to remain in London and that its fate is subject to the exit negotiations triggered by activating Article 50.

That view has been rejected by European Commission and EU Parliamentarians however, who insist that the EMA must move to an EU27 member state. There have also been reports that EU negotiators intend to ask the UK to pay for the relocation of the regulator from London.



Impurity failings top causes of CEP deficiencies, says EDQM

A lack of discussion on the risk of having potential mutagenic impurities in pharmaceutical substances was the number one deficiency in a sample of 20 Certificates of Suitability (CEPs) filed in the second half of 2015 and early 2016, according to the European Directorate for the Quality of Medicines and Healthcare (EDQM).

The EDQM public document notes that applicants are expected to provide a complete discussion on mutagenic impurities in their application for a CEP in order to meet the requirements of ICH M7, which has been in force since January 2016.

The second most common deficiency listed is related to the impurity profile of starting materials – specifically the "absence or insufficient discussion on fate and carryover of related substances of starting materials (included) to the final substance."

"Applicants need to know what kind of impurities can be found in starting materials, in particular with regard to related substances since usually these are molecules that can react according to the chemistry foreseen by the process, leading to impurities in intermediates and potentially in the final substance," notes the EDQM.

The full list of deficiencies runs as follows:

  1. Absence or deficient discussion on the risk of having potential mutagenic impurities in the final substance.
  2. Absence or insufficient discussion on fate and carryover of related substances of starting materials (included) to the final substance.
  3. Lack of details and/or poor description of the manufacturing process of the substance from the introduction of starting materials (synthesis, narrative description, flow charts, recovery and reprocessing procedures). Incongruences noted between information given in section S.2.2 and section S.2.4.
  4. Non-acceptable starting materials, necessity to redefine them earlier in the process.
  5. Non-adequate or poorly justified specifications in place to control the quality of starting materials.
  6. Non-adequate or missing specifications (and analytical methods) for reagents and solvents (recovered and recycled included) used to manufacture the substance from the introduction of starting materials.
  7. Non-adequate or missing discussion on carryover of reagents and elemental impurities to the final substance.
  8. Non-adequate or poorly justified specifications in place to control the quality of isolated intermediate.
  9. Absence or insufficient discussion on fate and carryover of impurities from synthetic intermediates (included) to the final substance.
  10. Non-adequate or missing information on the synthesis of starting materials and their manufacturers.



MHRA says quality system issues head 2016 deficiency list

Problems with quality systems topped the list of Good Manufacturing Practice (GMP) inspection deficiencies recorded by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last year.

The data applies only to dosage form inspections, but give a flavour of the issues that most commonly came to the attention of inspectors during the 324 site visits carried out last year.  The ranking appears as follows:

  1. Quality system;
  2. Sterility assurance;
  3. Production;
  4. Complaints and recall;
  5. Qualification/validation;
  6. Premises & equipment;
  7. Computerised systems;
  8. Personnel;
  9. Documentation; and
  10. Quality control.

Quality systems also topped the list in 2015, but documentation and quality control issues were encountered more frequently in that year, appearing at positions three and four just behind complaints and recall.

With regard to quality systems (Chapter 1), there were multiple examples of deficiencies related to incident investigations and corrective and preventive action (CAPA) implementation, for example when deviation reports did not contain sufficient information to describe investigations fully, there was a lack of management oversight of the quality system or when there was a lack of control on change control management.

The full 100-page report is available here.



EMA seeks closer links with academic groups

The European Medicines Agency (EMA) has developed a framework and action plan to try to foster tighter working relationships with academic researchers, including mutual learning and training.

The EU regulator's executive director Guido Rasi notes that academic groups "play an important role in helping the EU medicines regulatory network keep abreast of the opportunities and challenges brought by science, be it in the context of the development, assessment or safety monitoring of medicines."

The framework aims to raise awareness of the mandate and work of the EMA, help academics translate their discoveries into novel methodologies and medicines, and ensure that the EMA gets "the best scientific expertise and academic research" to support its activities, says the EMA.

Having closer ties with academic experts will help accelerate the adoption of scientific advances in the development of regulatory science, it continues. The agency has also set up a dedicated page on its website for academia.



Recommended reading

Continuous manufacturing is driving more focus on excipient fitness for purpose

The deployment of continuous manufacturing (CM) is prompting the pharmaceutical industry to understand better the characteristics of the excipients they are using and work more closely with suppliers to assure that the materials are fit for purpose. CM is also prompting a harder look at how to open up the clearance pathway for new/modified excipients that would better serve the advanced processing needs and objectives.

IPQ News

Industry asks US FDA to 'pause' data quality reporting plan

API, excipient and drug industry groups have reiterated concerns about the latest iteration of the US FDA’s “quality metrics” reporting requirements. 


UK triggers Brexit: what's next for the UK, MHRA and EMA?

UK Prime Minister Teresa May on Wednesday set in motion the UK’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will see some significant changes over the next few years.


Chinese and US Pharmacopeia projects keep the CRC busy

The name sounds solemn and serious – Compendial Review and Harmonization Committee (“CRC”) – and while the subjects with which they deal are indeed very weighty, the pace and volume of their work belies the slow-moving, bureaucratic impression which the name may evoke.

IPEC-Americas Insider

Understanding how excipients affect drug quality

In implementing Quality by Design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.


EMA-FDA QbD pilot program led to further harmonization

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further harmonization of concepts introduced through the International Council for Harmonisation (ICH).


ECA reviews use of hoses in the pharmaceutical industry

Hoses are omnipresent in the production of medicinal products, but can present a range of disadvantages compared to permanently installed pipes, says the European Compliance Agency (ECA). Hoses need to be qualified before use. In the course of qualification, some elements must be checked or determined such as cleaning, disinfection, sterilisation, intended purpose (single / multi-use), i.e. leach out, examination of the inner surface, particle release, durability, test procedure.




Download IPEC Europe guides

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

  • 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
  • 2006 The IPEC-PQG GMP Guideline
    Download PDF
  • 2006 The IPEC GDP Guideline
    Download 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.

Emerging Pharmaceutical Manufacturing Summit 2017: OSD Continuous Manufacturing in the Current Regulatory Landscape
Malta - May 8-9, 2017
More information here.

APV Expert Workshop: The Preformulation Tool Box: The Key to Enter Successful Drug Development
Berlin, Germany - 8-9 May. 2017
More information here.

APV Expert Workshop: Manufacturing Classification System (MCS) Expert meeting
Berlin, Germany - 9-10 May, 2017
More information here.

Philadelphia, US – 16-18 May, 2017
More information here.

AFI 57th Symposium
Rimini, Italy - 7-9 June
More information here.

ExcipientFest Asia
Beijing, China - 13-14 July, 2017

Conference on the place of the Certification Procedure in the global regulatory environment
Prague, Czech Republic - 19-20 September 2017
More information here.

PowTech 2017
Nuremberg, Germany - 26-28 September 2017
More information here.

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