IPEC e-newsletter - Excipients Insight December 2017 - 18-12-17

 

Editorial

Dear colleagues,
 
And so we’re here again. The end of another year, as hard as that is to believe! As you’ll see in the various updates in this edition, our committees and task forces have been reviewing what’s been achieved in 2017 and in preparation for our forthcoming meetings in Bordeaux, planning the next steps towards achieving our Agenda 2020 goals. This has been our guiding light, our North Star even, for the last three years and has been a defining point in our development to help IPEC Europe fulfil its role as a link between all stakeholders in the field of pharmaceutical excipients and to create more value for members. We’ll be updating our members at the Annual General Meeting in Bordeaux where we are on that particular journey. Most importantly though, we welcome your active participation in those sessions so you can provide your direct input into our plans as there is no better way to help us check that our direction is aligned with yours. We’re so looking forward to hearing from all the diverse representatives that IPEC Europe embodies so that when we say we’re the voice of excipients, we can stand behind that!

The IPEC Europe Board convened in Brussels for its last meeting of 2017, and like the other groups in IPEC, we focussed on accomplishments and the New Year. One thing which stood out to me in this last year is the intensive work which had been undertaken by the Secretariat on infrastructure improvement projects. These are very specifically targeted at being able to better support our members with better quality information and also reach out wider to the others in our world. Early in 2018 we’ll be launching our redesigned website and branding as a platform for these objectives with the real endeavour of attracting new recruits to our association, which for sure will help us to accelerate our ambition.

And so, for one last time in 2017, I would like to recognise what we have done as an association which I’ve talked a lot about in previous editions of Excipients Insight. Thanks to the many of you who can be relied upon to make everything happen and of course, to our Secretariat for keeping us on track. I look forward to welcoming many of you in Bordeaux, a first for us in this location for our Annual Forum and General Meeting. You can find out more about our programmes there and there’s still time to register if you’d like to join us.
 
I hope to see you there but meanwhile, wishing you a wonderful holiday season and a healthy and prosperous 2018.

 


 

ICH Q3D taskforce looks ahead to first inspections in 2018

The IPEC ICH Q3D Task Force has had a busy year, focusing its attention on monitoring the implementation of the guidelines and the efforts of pharmaceutical manufacturers  to ensure their existing products are in alignment with the new requirements. From an objective standpoint, the impression has been that the compliance process has gone rather smoothly - assessments reveal no products failed compliance tests and in just a few cases control strategies had to be implemented for new products.

The Task Force would like to hear from excipient manufacturers as they pass the one-year timeframe from the start of the new requirements, and this will be one topic of discussion in a teleconference scheduled to be held on 18 December, ahead of the festive break.

Looking ahead to 2018, the team anticipates the outcome of the first inspections where the Q3D risk assessments made by companies will likely be a key feature. It will be interesting to see how the detailed risk assessments are viewed by authorities and what if any implementation issues they uncover. Once the outcome of inspections becomes clearer the taskforce will seek to decipher these to determine what if any further materials it may need to  develop to help companies align with inspectors' expectations.

 


 

Quality and Regulatory Affairs Committee (QRAC) meets in Darmstadt

On 16 November, the IPEC Europe Quality & Regulatory Affairs Committee (QRAC) was hosted by Evonik GmbH at their facilities in Darmstadt, Germany. This was the fourth meeting of 2017 and the agenda covered a range of topics which included a significant discussion on PharmaEuropa’s second draft of its monograph on co-processed excipients. All comments are being complied, including those from sister associations, for submission back to EDQM before the end of this year.

Attendees (both physically present and online) welcomed an update on the changes to the EXCiPACT standard, the new version of which is available for download here. A topic which features regularly at QRAC meetings is elemental impurities, with one perennial point of discussion being that the USP approach to replacing classic ‘heavy metals’ testing differs from EDQM. USP has been collaborating with IPEC-Americas to request test data from the excipients community to help establish test parameters which USP feels are appropriate for excipients. The instructions on how members can submit their data if any company wishes to participate is available from the IPEC Europe Secretariat.

Another request for collaboration was shared with the team, namely that the Chinese Pharmacopoeia (ChP) is encouraging companies to provide samples and data to support their excipient monograph development and review programme. Also, ChP proposals for excipient nomenclature which are being circulated for comment across the membership, were discussed. The most significant issue is that if ChP introduces a practice for nomenclature based on specific routes of administration, this could create major disharmonization with other global pharmacopeias. Trade issues may also arise for global excipients imported into China.

Plans were fixed to deliver a position paper on primary packaging materials for excipients in the near term, and the group conveyed a strong preference that QRAC initiates a project in 2018 to develop a full guide on this subject. With the imminent launch of the Quality Agreement Guide the working group was formally disbanded and great thanks were expressed to Astrid Stockrahm-Uhling and her colleagues for their tremendous efforts. Astrid will now take the lead for IPEC Europe with the next version of the IPEC-PQG GMP Guide.

Some new topics were brought to the table, including a growing trend for statements on the gluten-free status of medicines and recent ICH discussions on sunscreens and elemental impurities. Finally, the group held a short thought shower to discuss 2017 achievements and 2018 objectives which will be presented at the next meeting in Bordeaux, as part of IPEC Europe annual event.

 


 

Pharmacopoeial Review & Harmonisation Committee rings the changes

With the changes in the leader roles of the Pharmacopoeial & Harmonisation Committee in 2016, this has been a year of considering how we can reinvent ourselves to better align with current interests on these topics. Clearly, a strong relationship with with EDQM must remain at the forefront of our goals and early in 2018, a meeting will be set to outline our working relationship moving forward. Members have also expressed a keen desire for focus on other emerging global players in the pharmacopoeial arena, such as Brazil , China and India. And last but not least, global Harmonisation efforts will continue through IPEC Federation’s interactions with the Pharmacopoeial Discussion Group (PDG). 

In the coming weeks we’ll be conducting a survey to better inform discussion on compendia and harmonisation at IPEC Europe’s annual events in Bordeaux next month. There will be an open forum on 31 January where those with an interest in the PR&HC and its future, can join to provide direct input! We’re hoping to see many of you there! 

 


 

EXCiPACT looks back on transformative year

2017 has proved to be EXCiPACT’s best year ever for certifications and re-certifications, with numbers rising globally by over 50% to 62 during the year and many more expected in early 2018.

Another milestone was also passed with the completion of the organization’s restructuring and the appointment of Alain Becart, ex-Sanofi, as Quality Manager and Dale Carter joining the Board as the IPEC-Americas representative.

From a technical perspective, EXCiPACT’s revised 2017 standards were published in November - replacing the original 2012 edition – and sincere thanks go to Iain Moore and his team who worked so hard on the project and successfully aligned the new ISO 9001:2O15 and ISO/IEC 17021-1:2015 standards with the existing GMP and GDP standards to create the new standards.

The transition to the new standards for new certifications, re-certifications and surveillance audits will be effective from 1 April, 2018, and a summary of the changes made in creating the new version will shortly be available on the EXCiPACT website. A Chinese language version is in preparation and should be ready for publication early in the first quarter of 2018.

Also published in November was EXCiPACT’s redesigned website making it easier for users of mobile phones, tablets, laptops and desktop computers to quickly find what they need. A revised logo (see above) was also launched at the same time.

Other highlights in 2017 included hosting EXCiPACT’s most successful webinar to date in October, with more than 200 registered delegates from around the world. EXCiPACT President Kevin McGlue gave the presentation and answered questions during and after the event.

Another successful China workshop organised by a local consultant was held in Shanghai in July where EXCiPACT Vice-President, Dr Sabari Roy, made two presentations. With the help of IPEC China, the association participated in CPhI China and ExcipientFest Asia.

Three new auditors completed two-day training courses in Milan in September, and Certiquality srl based in Italy became EXCiPACT’s seventh Registered Certification Body this year. To celebrate, the two organizations shared a stand at the annual AFI Seminar in Rimini in June.

It was also gratifying to be nominated as one of five finalists of the 2017 CPhI Annual Awards in the Regulatory category in October in Frankfurt.

“We look forward to building on this year’s success in 2018 with a revitalised marketing programme,” commented McGlue, who added that annual business review meetings with our Certification Bodies, which provide an opportunity to review progress and to share ideas for growing the business on a cooperative basis, have now largely been completed.

“Our annual General Assembly will be held alongside the IPEC Europe Annual Excipients Forum in Bordeaux on 31 January 2018,” he added.

 


 

Survey: Feedback on Excipients Insight

The first responses to our survey on Excipients Insight has now come in and – while the sample size is still fairly small – it is encouraging to note that a majority of response are favourable with regard to the newsletter’s content and length, timeliness, frequency and readability. The most popular content was regulatory and quality/GMP news, with compendial updates and editorials also scoring fairly high.

It’s worth noting that most respondents (more than 80%) were from non-members, and we would encourage more of you to provide your feedback on the publication. Constructive criticism will be invaluable as IPEC Europe embarks on the process of updating the newsletter and association website next year. As a reminder, the survey can be accessed here.

 


 

IPEC Europe calendar

Group Q1 2018
IPEC Europe Board 16 March
GDP Committee 31 January
Pharmacopoeial Review & Harmonisation  
Quality/Regulatory Affairs 31 January

 


 

Conference report: WHO meeting on pharma preparations

Adrian Boneby Adrian Bone - Senior Advisor to IPEC Europe

IPEC was privileged to receive invitation as an observer to this important meeting which ran from 16-20 October at the WHO’s Geneva Headquarters. As well as global WHO representatives and advisers, international organisations, non-state actors (which includes IPEC) and pharmacopoeias were in attendance. While there were not many issues on the agenda directly related to excipients, this is a great opportunity for IPEC to raise the subject of excipients appropriately to ensure their unique challenges are not overlooked in the supply of medicines.

The opening session focussed on general policy issues such as those which cut across other WHO groups active on biological standardization, traditional and complimentary medicines, essential medicines, substandard and falsified medical products and antimicrobial resistance. Updates from international collaboration agencies, the Global Fund, UNDP and UNICEF all mentioned that a common difficultly they encounter as part of their procurement of medicines is the lack of harmonisation between analytical methods in use and their pharmacopoeial counterparts. An update on the recent PDG meeting from Dr Kevin Moore (USP) in September in Rockville, USA some weeks ago restated those key points presented in the October edition of Excipients Insight. A recent survey conducted on the use of international non-proprietary names (INNs) indicated that they are not well understood, and this has led to a series of educational initiatives.

Compendial matters

The audience was informed of the launch of the 7th edition of the International Pharmacopoeia (Ph. Int.) where major changes relate to new and revised monographs for drug substances and finished products, but not excipients. This review did result in many monograph deletions and prioritisation for future action. The Committee considered multiple monograph creations / revisions by therapeutic categories which did highlight that there is currently no Ph. Int. strategy for heavy metals / elemental impurities in line with ICHQ3D requirements. Meanwhile, current expectations apply. It was noted later that monographs (and the associated international reference standard) are only deleted after consultation and confirming that those impacted are not included in Essential Drugs / Expression of Interest listings. In the course of reviewing the (many) new/revised API and drug product monographs, an expedited process was put in place and request was made that this is subsequently formalised by the Secretariat. Essentially, for well-established monographs, even though the document had been through expert review but not public consultation, comments could be incorporated and proceed to publication rather than bringing the final version back to the next Expert Committee meeting in the following year. Also, it was restated that where specification limits are broadened to align with other compendia, this is sufficient rationale as the Ph. Int. does not want to be more stringent that other pharmacopoeias. It was generally agreed that describing deleted monographs / reference standards as ‘omitted’ should be replaced by ‘retired’ or other suitable wording. Retaining reference standards for one year after ‘omission’ was accepted with due recognition that after this period neither monographs or standards are maintained. The International Reference Standards workplan for 2017/2018 was approved but the lack of RS availability for new but already available monographs was recognised. This is largely due to difficulties in obtaining materials from manufacturers. The Custodian Centre for Ph. Int. reference standards is EDQM, which provided an update on recent activities.

Following a major project in cooperation with the International Atomic Energy Agency (IAEA), all monographs for radiopharmaceuticals have been revised, for which the final technical decisions were made by IAEA, in view of their expertise in this field.

Some time was devoted to discussion on world pharmacopeia activities. WHO jointly hosted a meeting in Brazil in July 2017 where agenda items included Good Pharmacopoeial Practices (GPhP) chapters on compounding and herbal medicines (which were extracted from the main GPhP text). An outcome on herbals after discussion with the WHO Traditional and Complimentary medicines team was the development of Good Herbal Processing Practices. A statement on Antibiotic resistance was agreed and posted on the ANVISA web site. The 2018 forum will be in Vietnam. The Expert Committee approved both chapters subject to the British Pharmacopoeia (BP) making edits based on the latest comments received.

The high-level outcomes of the WHO survey on GPhP were presented which was completed by a broad range of stakeholders. In general, feedback indicated that of the 134 respondents, 68% were aware of WHO GPhP but in terms of implementation, only parts had been adopted. It was interesting to note that of the comments made, a theme was that this document would not be so useful until all pharmacopoeias embraced the need for harmonisation.

Quality & GMP

The WHO External Quality Assurance Assessment Scheme continues which assesses the proficiency of WHO accredited laboratories. In the latest phase which focuses on dissolution testing, there were eleven participants. WHO supports any failing laboratories with advice on improvements but errors can be basic. This is now a fee-paying scheme which has reduced participants (mostly from well developed countries as fees are higher) but the incentive to get involved is that is forms part of WHO accreditation.

The WHO Guidance on Testing of ‘Suspect’ substandard / falsified medicines has been renamed Guidance on Testing of ‘Suspect’ Falsified Medicines. Reference to substandard products was removed so as not to confuse with authentic products (which could be substandard, too). The redraft presented, is also intended to provide guidance to testing laboratories so details of other processes such as chain of custody, will be delivered through training rather than in this document. Wording suggesting that samples could always be frozen to protect their integrity was removed.   

WHO is still engaged in a quality monitoring process of its pre-qualified quality control labs to test products on its EML.  Five more labs have been certified in 2016 and 47 are in process. A variety of deficiencies were found for which WHO may provide technical assistance through training or peer audits. Auditors have been provided training by WHO. The results of a study with anti-retrovirals (ARVs) identified that the majority of Patient Information Leaflets (PILs) provided with product did not comply with WHO information. It has not been clarified if discrepancies were related to changes requested by National Regulatory Authorities (NRAs) (as EML products must also receive local regulatory approval). However, all QC tests were compliant. A pilot study for anti-malarials showed that NIR technology was useful but not Raman spectroscopy to assist in their rapid identification.

A session on GMP guidelines informed that a sterile products GMP Guide is under development as a collaboration between WHO, EMA and PIC/S. The document is currently under review within the European Commission and it is expected to be issued for comment before the end of 2017. Appendices (systems/utilities/equipment; analytical methods; computerised systems) to the WHO Validation document are being revised to include comments following consultation but due to resource issues within the Secretariat and Working Groups, delays for the next round of consultation are not known. The main issues with the revised guide on GMP for HVAC of non-sterile facilities related to risk management and a requirement to perform recovery rates of the air system. Despite challenges that this is not a requirement in other GMPs, it was retained but qualified with ‘as required’. The document was approved as Part I. Part II, providing explanatory notes and interpretation will follow at a later date.

Revisions to the QAS/16.694 Stability Testing of API and Finished Product were agreed subject to some amendments and clarifications. Most discussion centred on the permissible window and storage conditions of time point samples awaiting testing. Work continues to establish a process and pilot for solubility profiles of essential drugs which will allow biowavers for drugs on the EML. Brazil and China offered the services of laboratories to pilot the proposed procedure.   

Regulatory processes

Much effort is being dedicated to establishing guidance for key regulatory processes, one of which is to expedite access to medicines (Procedure in assessment of accelerated national registration of pharmaceutical products and vaccines approved by Stringent Regulatory Authorities). This is complemented by guidance where NRAs wish to determine when a desk review may be substituted for a GxP on-site inspection and Good Regulatory Practices. Discussions were extensive but ultimately it was agreed that all would continue through the development process with implementation beginning in 2018. The GRP will be supported by training tools and establishing centres of excellence to support other NRAs. A concept paper was also adopted whereby guidance helping NRAs to implement the various procedures planned. An accelerated process already exists for Pre-qualified products (Collaborative Regulatory Procedure, CRP) but now there will be provision for non-prequalified products. Despite its scope being limited to small molecules and generics for now, it is believed this expedited procedure may help liberate capacity within NRAs.

To support the strengthening of NRA’s in terms of efficiency and effectiveness, the Expert Committee approved a proposal to develop guidelines to implement Quality Management Systems at NRAs. These will be based on IS09001:2015 with the emphasis being on implementation rather than achieving certification. Following a survey and gap analyses by WHO, strong support will be needed from to achieve this goal in LMICs (Lower/Middle Income Countries).

Sessions on pre-qualification of priority essential medicines and APIs and nomenclature, terminology and databases were not attended.

Considering IPECs participation at this meeting, the items of most relevance to IPEC were those relating to pharmacoeial activities. However, in future, it is good if IPEC representative(s) can attend the whole meeting but have the breadth of knowledge to contribute to other topics beyond compendial matters. Of course, there may be items directly applicable to excipients! As the meeting dates are reliably predictable, the attendee(s) should be identified as early as possible to allow adequate time for proper review of the documentation and consultation within IPEC, if appropriate. 


THESE NOTES WERE PREPARED BY THE IPEC REPRESENTATIVE AT THIS MEETING AND DO NOT REPRESENT AN OFFICIAL REPORT. CONSEQUENTLY, THE DETAILS PROVIDED SHOULD BE CONSIDERED AS INFORMATIVE ONLY. THE OFFICIAL PROCEEDINGS OF THIS MEETING WILL BE PUBLISHED IN 2018.

 


 

China publishes new excipient regulation

There has been yet another development in the fast-changing Chinese regulatory environment for excipients, with a new regulation published towards the end of November.

The regulation (link to document in Chinese) introduces some fundamental changes to the way excipients are regulated in China. They will no longer be considered for approval separately but – along with active pharmaceutical ingredients and packaging materials – will now be regulated using a submission system akin to the Drug Master File (DMF) approach used in other regulatory jurisdictions.

Under the new system excipient companies can submit dossiers for excipients themselves, and after submission a registration number will be assigned, and these will be “reviewed and approved after the registration application of the connected drug product is proposed,” according to a translation of the regulation kindly provided by IPEC China.

IPEC China notes that according to the China Food and Drug Administration (CFDA) announcement, excipients used in imported finished drugs are also covered by the new regulation.

All excipients need to be registered if they are intended for use in a new drug application, except for those used in dedicated finished drugs. If used “by the drug product applicant only, or exclusively used by the particular marketing authorization holder”, a dossier needs to be included with the drug application.

CFDA is still working on the platform on dossier electronic submission. Before it is finished, registration applications to the Centre for Drug Evaluation (CDE) will have to be on CD-ROM. Other detailed requirements for bundling review and approval of the drug substances, excipients and drug packaging materials as well as drug products is also being developed by CFDA, and this should soon be published for comments, according to IPEC China.

An English translation of the new regulation is now available and can be requested from the IPEC Europe secretariat.

 


 

EC adopts GMP guidelines for advanced therapy medicinal products

The European Commission has adopted new guidelines, which it says were developed after extensive consultation with stakeholders and competent national authorities, to adapt the GMP requirements to the specific characteristics of advanced therapy medicinal products (ATMPs) such as cell and gene therapies.

They address novel scenarios such as “decentralised manufacturing, automated production, and reconstitution of ATMPs and take a risk-based approach, allowing manufacturers some flexibility in their processes and control systems, depending on the level of risk,” according to the Commission.

A question and answer document has also been published in association with the new guidance.

 


 

FDA publishes first guidance on 3D-printed pharmaceuticals

The US Food and Drug Administration (FDA) has become the first regulator in the world to issue a technical framework for manufacturers creating medical products on 3D printers.

The new guidance explains the agency’s thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements, and is billed as its “initial thoughts” on the emerging technology, also known as additive manufacturing (AM).

The guidance includes a section (D) on Material controls, and says of starting materials (D.1) such as processing aids, additives, and cross-linkers that they may "undergo significant physical and/or chemical changes" during AM and the specifications for incoming materials and test methods "should be based on the AM technology used ... the intended use of the final medical product, and the information available.

According to FDA Commissioner Scott Gottlieb the new document will “help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”

In an official statement, Gottlieb notes that patients are already benefitting from 3D-printed healthcare products – the first 3D-printed drug (an epilepsy medication) was approved by the FDA back in 2015 – but adds that the FDA “is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice.” More than half a dozen manufacturers have approached the agency to express interest in using 3D printing in some capacity to product medicines.

“We’re working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.”

That shouldn’t require the formulation of additional laws and regulations, he suggested.

 


 

EMA publishes guidance to help pharma companies prepare for Brexit

The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the UK’s withdrawal from the EU.

The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisation to allow for the continued marketing of their medicine in the European Economic Area (EEA) after the UK withdraws from the EU.

The guidance has been prepared on the basis that the UK will become a third country as of 30 March 2019, says the EMA. It should be read in conjunction with an associated questions and answers document.

 


 

10% of medicines in developing countries 'substandard or falsified' says WHO

An estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, according to new research from thge World Health Organization (WHO).

“Substandard and falsified medicines particularly affect the most vulnerable communities,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable. Countries have agreed on measures at the global level – it is time to translate them into tangible action.”

Since 2013, WHO has received 1500 reports of cases of substandard or falsified products. Of these, antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from the WHO African Region, 21% from the WHO Region of the Americas, and 21% from the WHO European Region.

This is likely just a small fraction of the total problem and many cases may be going unreported. For example, only 8% of reports of substandard or falsified products to WHO came from the WHO Western Pacific Region, 6% from the WHO Eastern Mediterranean Region, and just 2% from the WHO South-East Asia Region.

“Many of these products, like antibiotics, are vital for people’s survival and wellbeing,” says Dr Mariângela Simão, Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals at WHO. “Substandard or falsified medicines not only have a tragic impact on individual patients and their families, but also are a threat to antimicrobial resistance, adding to the worrying trend of medicines losing their power to treat”.

Prior to 2013, there was no global reporting of this information. Since WHO established the Global Surveillance and Monitoring System for substandard and falsified products, many countries are now active in reporting suspicious medicines, vaccines and medical devices. WHO has trained 550 regulators from 141 countries to detect and respond to this issue. As more people are trained, more cases are reported to WHO.

WHO has received reports of substandard or falsified medical products ranging from cancer treatment to contraception. They are not confined to high-value medicines or well-known brand names and are split almost evenly between generic and patented products.

Meanwhile, WHO has also published research that estimates a 10.5% failure rate in all medical products used in low- and middle-income countries.

This study was based on more than 100 published research papers on medicine quality surveys done in 88 low- and middle-income countries involving 48,000 samples of medicines. Lack of accurate data means that these estimates are just an indication of the scale of the problem. More research is needed to more accurately estimate the threat posed by substandard and falsified medical products.

Based on 10% estimates of substandard and falsified medicines, a modelling exercise developed by the University of Edinburgh estimates that 72,000 to 169,000 children may be dying each year from pneumonia due to substandard and falsified antibiotics. A second model done by the London School of Hygiene and Tropical Medicine estimates that 116,000 (64.000-158,000) additional deaths from malaria could be caused every year by substandard and falsified antimalarials in sub-Saharan Africa, with a cost of an estimated $38.5m to patients and health providers for further care due to failure of treatment.

Substandard medical products reach patients when the tools and technical capacity to enforce quality standards in manufacturing, supply and distribution are limited. Falsified products, on the other hand, tend to circulate where inadequate regulation and governance are compounded by unethical practice by wholesalers, distributors, retailers and health care workers. A high proportion of cases reported to WHO occur in countries with constrained access to medical products.

Modern purchasing models such as online pharmacies can easily circumvent regulatory oversight. These are especially popular in high-income countries, but more research is needed to determine the proportion and impact of sales of substandard or falsified medical products.

Globalization is making it harder to regulate medical products. Many falsifiers manufacture and print packaging in different countries, shipping components to a final destination where they are assembled and distributed. Sometimes, offshore companies and bank accounts have been used to facilitate the sale of falsified medicines.

“The bottom line is that this is a global problem,” says Dr Simão. “Countries need to assess the extent of the problem at home and cooperate regionally and globally to prevent the traffic of these products and improve detection and response.”

 


 

Recommended reading

Are low generics prices at risk of causing shortages and sudden spikes?

A familiar argument voiced in pharma is that the price of new drugs has to be kept high to pay for tomorrow’s medicines, and those pursuing new innovations can point to figures such as Deloitte’s finding that return on research and development (R&D) has dropped to below 4%, to show how tough drug discovery and development has become.

ThePharmaLetter.com

Lipid-based suspension can unlock new horizons in oral bioavailability

It might be an understudied and unfashionable delivery method, but lipid-based suspension could unlock new horizons in oral bioavailability. René Holm of Janssen Belgium talks to Eleanor Wilson about what this ‘sleeping beauty’ of pharmaceuticals can do for parenteral drug delivery.

Worldpharmaceuticals.net

Continuous manufacturing can improve quality in pharmaceutical industry

Moving from batch to novel production is no easy task. The same goes for building bridges between manufacturing processes, as well as the role and process of analytical technology. Continuous manufacturing could be the solution, but many pharmaceutical experts have met this notion with resistance. Salvatore Mascia, founder and CEO of CONTINUUS Pharmaceuticals, explains how this method can increase quality assurance and efficiency.

Worldpharmaceuticals.net

 


 

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
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  • 2017 The IPEC Co-processed Excipient Guide
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  • 2017 The Joint IPEC-PQG Good Manufacturing Practices Guideline - Updated version
    Download PDF
     
  • 2017 The IPEC Good Distribution Practices Guideline - Updated version
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  • 2016 IPEC Europe 'How-To' document on Risk Assessment
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  • 2014 The IPEC Glossary of Terms
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  • 2014 The IPEC Significant Change Guide: Third revision
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  • 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.


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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