Excipients Insight - IPEC Europe

EUROPE
Excipients
Insight
www.ipec-europe.org October 2008
In this edition...
Certification efforts step up . . . . . . . . . . . . . . . . . .page 1
The word from the chair . . . . . . . . . . . . . . . . . . . . page 2
Board updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 2
- 2009 AGM and seminar
- Board elections
US seeks country-of-origin labelling . . . . . . . . . . page 2
News from the IPEC Committees . . . . . . . . . . . . page 3
- Harmonization Committee
- GMP Committee
- Regulatory Affairs Committee
- GDP Committee
Push for allergen labelling . . . . . . . . . . . . . . . . . . page 3
Heparin update . . . . . . . . . . . . . . . . . . . . . . . . . . . page 3
Eye on Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 4
- Radiopharmaceuticals GMP regulation
- PharmEuropa: new edition published
- EDQM advises on Certificates of Suitability
- Triethanolamine status change
IPEC conferences in profile . . . . . . . . . . . . . . . . . page 4
REACH deadline approaches - are you ready? . . . page 4
Eye on the World . . . . . . . . . . . . . . . . . . . . . . . . . page 5
- Bid to resolve residual solvent confusion
- ICH November meeting and agenda
- Latest developments at WHO
IPEC Americas conference report . . . . . . . . . . . page 5
IPEC China elects chair . . . . . . . . . . . . . . . . . . . . page 5
TriPEC updates . . . . . . . . . . . . . . . . . . . . . . . . . . page 5
Science and Technology . . . . . . . . . . . . . . . . . . . page 6
- FDA seeks input on nanotechnology guidance
- Quality by Design for inhaled and intranasal drugs
Events Calendar . . . . . . . . . . . . . . . . . . . . . . . . . . page 6
Excipient industry news . . . . . . . . . . . . . . . . . . . page 7
- Pfizer API unit to use Prosonix’
- Beneo-Palatinit introduces filler/binder
- Novozymes wins gold with hyaluronic acid
- ISP adds to range of pharmaceutical coatings
- Univar’s chlorhexidine gluconate gets CEP
- Dow working to restore PEG capacity
IPEC, EFCG move certification
project forward
Efforts to advance the creation of a pan-European
certification programme for excipients are
now gaining momentum. In the latest development,
IPEC Europe and the European Fine
Chemicals Group have formed a European Pharmaceutical
Excipients Certification Project to
bring the process forward.
A early objective is to create a ‘certifiable
standard’, expanding on earlier work by IPEC
Europe and the Pharmaceutical Quality Group
(PQG) in setting good manufacturing practice
(GMP) and good distribution practice (GDP)
standards.
IPEC Europe, IPEC Americas, and PQG agreed
in September to set up Steering Committee with
the purpose to draft an international standard for
excipients, based on the IPEC/PQG Excipients
GMP guide, and on ISO 9001:2000 requirements.
The discussion will start with a conference
call this month.
“The standard will be supported by an internationally
recognised certification scheme for excipient
suppliers, an approach which indicators show is
favoured by Industry and regulators,” said IPEC
Europe and EFCG in a joint statement.
Certified
Although the project remains in the early stages,
the objective is that certification would create a
system whereby excipient suppliers could become
accredited by third-party organisations. Ideally, the
accreditation groups would in turn be endorsed
by regulatory authorities. This is consistent with
IPEC and PQG's promotion of the use of voluntary
guidance through the implementation of an
appropriate quality system, rather than legislation
which cannot be enforced because of the unique
diversity of the excipients' industry.
The contaminated glycerin and heparin cases
have put the industry under the spotlight. Even
though these events are exceedingly rare, it is
important that IPEC Europe and other groups
demonstrate that the industry is proactive in its
approach to product quality.
It is anticipated that in Europe the certification
scheme will be run by EFCG in conjunction with
IPEC Europe, with IPEC Americas adopting a
similar approach in its home territories. Certification
of manufacturers and distributors would contribute
to the overall assurance of excipient quality,
sought by regulators of medicines and their
manufacturers.
The initiative is complementary to and supports
the collaboration that IPEC Europe has
undertaken with EFCG to promote a Certification
Programme for excipient manufacture in
Europe.
October 2008 www.ipec-europe.org 1

Board Updates
2009 AGM and Seminar
Preparations are now in full swing for the IPEC
Europe Annual General Meeting and Seminar,
which will be held on the morning of 23 January
2009 at the Majestic Hotel in Cannes.
New IPEC Europe Members will be introduced
and welcomed, and the Board and the Committees'
chairs will report on the Activities and
Objectives achieved in 2008 and those planned
for 2009. Three new Board Members will be
elected in the course of the AGM (see below).
A financial update will be given and approval of
the 2009 budget will be sought by members' representatives.
An update on TriPEC activities will
also be made.
Board Elections
Autumn is now well and truly upon us, and with
the summer fast receding into distant memory
many of us will now be in the midst of another
conference season.
Some of you may have attended the CPhI exhibition
in Frankfurt, which gave a perfect
opportunity to announce progress
in our collaboration with EFCG on the
development of a certifiable standard
and certification programme for excipients.
This important topic is the subject
of our lead article this month.
Excipients Insight also covered other
pertinent news from the show and you
can see a number of new developments concerning
excipients in the pages of this edition.
It is home-grown conferences that head the
menu for IPEC Europe in the coming months,
however, with three major events in the calendar.
First up is the TriPEC meeting in November will
once again coincide with the biannual ICH conference
and provide a great opportunity for
The word from the chair
TriPEC members to interact with their peers in
the Pharmaceutical Development Group.
Shortly after that we have the conference on
GMP for excipients, which will take place 1-2
December. More details are available on page 4
of this issue. This conference features
an outstanding speaker panel from international
regulatory bodies and industry,
and represents a truly unique opportunity
for discussing developments and initiatives
of the major stakeholders.
Last but not least we have our annual
AGM and seminar in January 2009.
You can see the breadth of our seminar
programme on page 4.
I hope you find this edition useful, and look forward
to greeting you all in person in the coming
months.
On behalf of IPEC Europe Board,
Patricia Rafidison
US bill seeks countryof-origin
labelling
Chair to IPEC Europe
As you may be aware the term of office of Board
Directors is three years renewable. In 2009,
three of the Board Directors will be ending their
term:
O Patricia Rafidison, Dow Corning (Manufacturer)
O Adrian L. Bone, Eli Lilly (User)
O Michel Malandain, Seppic (Manufacturer)
As a result there three positions will become
available within the Board of Directors.
According to the Article 10 of the IPEC by-laws,
an election has to be organised. At least two representatives
of the two groups represented within
IPEC Europe; i.e. users and manufacturers, have
to be nominated candidate for the Board of
Directors.
All the nominations must be submitted by email
or fax to the IPEC Europe Secretariat by 5 January
2009 at the latest.
Email: info@ipec-europe.org
Fax: +32 2 732 34 37
The vote will be organised at the Annual General
Meeting on 23 January 2009 and the newly
Directors shall take their function at the following
Board meeting after the AGM.
A bill has been introduced to the US Senate
that would require the country-of-origin of
pharmaceutical ingredients to be labeled on
finished dosage forms.
This proposal covers both active pharmaceutical
ingredients (APIs) and excipients present
in prescription or over-the-counter (OTC)
products.
Including excipients under the
bill differentiates it from the proposal
in the draft of the US Food
and Drug Administration Globalization
Act, which was released
in April.
Under the proposal the country-of-origin of
each active and inactive ingredient would be
listed in descending order based upon the
quantity in the finished dose.
It appears that it will not be necessary to
include the country of origin of all raw materials
and intermediates, or the nation in which
every step in the synthesis process occurs.
This would provide a more comprehensive
view of the origins of an API or excipient but is
not mentioned in the bill, probably due to the
complexity of implementing such a measure.
Having been read twice in the Senate the bill
has been referred to the Committee on
Health, Education, Labor, and Pensions.
If implemented, the bill will take effect 180
days after the legislature agrees to enact it.
With the presidential election taking place,
and the current focus on militating against the
looming recession, the bill is
unlikely to be agreed upon in
2008.
Consequently its implementation
rests largely on the political
agenda of the new regime and
how other issues develop in the
coming months. The bill can be found here.
The bill has been put forward by Senator Sherrod
Brown (Democrat – Ohio), who in recent
months has called for the FDA to launch a probe
into pharmaceutical outsourcing.
Brown has raised concerns over the safety of
pharmaceutical products and the level of outsourcing,
writing letters to Pfizer and Merck &
Co requesting information on their use of
third-parties.
This excerpt of a longer article is provided
courtesy of www.in-PharmaTechnologist.com.
2 www.ipec-europe.org October 2008

News from the IPEC
committees
Harmonization Committee
The last meeting was held on 10 September, in Strasbourg, France. The minutes will be published in
the member’s area of the IPEC Europe website once available.
Some of the main issues the Harmonization Committee is currently working on include the following:
- Silica monographs.
- Monograph on crospovidone.
- Carmellose, Hydroxy-Propyl-Cellulose, and Ethyl-Cellulose.
The next meeting will be held on 30 October at Beneo-Palatinit in Mannheim.
If you are interested in participating in Harmonisation Committee activities, please contact the chair,
George Mansveld, or the vice-chair, Bernhard Fussnegger.
GMP Committee
The Excipient Qualification Guide is now in pre-publication, which is a fantastic achievement. The
GMP Committee chair, Iain Moore, would like to thank everyone who contributed to this document. As
soon as it is finalised it will be available in pdf format and circulated to members.
The initial meetings on the certification project (see page 1) have been held and arrangements are
being made to allow working parties to form and start work.
The next meeting will be held on 17 November at the ECCO offices in Brussels.
If you are interested in participating in GMP Committee activities, please contact the chair Iain Moore.
Regulatory Affairs Committee
Once again the key topic for the Regulatory Affairs Committee has been the poposed European Master
Files for Novel Excipients and Biological/ Biotehnological Active Substances. On 6 October an
IPEC Europe delegation (Kate Denton/Novozymes, Johann-Philipp Hebestreit/BASF, and Elena
Miceli/Secretariat) met with a delegation of the Pharmaceutical Unit at DG Enterprise of the European
Commission.
The aim of the meeting was to communicate IPEC Europe’s concerns and the difficulties faced by excipient
companies in Europe compared to other world areas due to the lack of an excipient master file system.
Ideas were exchanged and proposals put forward to address this issue. The Commission has
asked for practical examples to illustrate where such a system is needed and also requested that IPEC
Europe involve the EMEA in this discussion.
The next meeting will be held on 17 November.
If you are interested in participating in GMP Committee activities, please contact the chair, Carl Mroz.
GDP Committee
The last meeting was held on 5 September and the minutes are available on our website.
Work has continued on the harmonisation of the audit guide with IPEC Americas. US distributors comply
with the national system of the National Association of Chemical Distributors (NACD), and it is proposed
that NACD and the European Association of Chemical Distributors (EACD) could collaborate to
develop a common transatlantic document. For countries where no such auditing tools are available, a
master guideline based on the GDP guideline could be applied.
The next committee meeting will be held 6 November in Barcelona.
If you are interested in participating in GDP Committee activities, please contact the chair
Allan Whiston.
Pushing for allergen
labelling
Few consumers are aware that many medicines
contain excipients derived from known allergens
or are produced in facilities where allergens may
be present, according to an article published in
Pharmaceutical Technology Europe.
Allergies are not dosedependent
and individuals
exhibit different sensitivity at
different occasions, making it
impossible to set a maximum
exposure level similar to that
of toxic chemicals.
There are strict requirements
for labelling pharmaceuticals, but some believe
that sufficient allergy-related information is
already provided in the package leaflet.
The labelling requirements for the food industry
have helped strengthen control of the supply
chain; it is possible that similar legislation for
pharmaceuticals could offer the same benefit,
according to the authors.
Recently, the Australian Allergen Bureau said
the pharmaceutical industry should be obliged to
label key allergens on outer packaging. If the
agency is successful in this campaign then the
process could be introduced in other countries.
This article excerpt has been reproduced with
grateful thanks to Pharmaceutical Technology
Europe
Heparin scandal prompts
workshop on quality
A workshop jointly organised by the European
Directorate for the Quality of Medicines, the
National Institute for Biological Standards and
Control (NIBSC) in the UK and the US Pharmacopeia
was held earlier this year in Strasbourg,
France, to discuss the characterisation and
quality control of heparin.
Earlier this year a contaminant sourced to a
Chinese factory was found in heparin supplies
in 11 countries, prompting widespread product
recalls.
Sessions at the workshop covered the current
situation and perspectives, global harmonization,
and low molecular weight heparin. It paid
special attention on the need to ensure traceability
of raw materials and the control of the
supply chain. The Australian authority pointed
out the need for GMP at all stages.
A summary document, available here, notes
"the supply chain of heparin was a critical step
in the production of heparin and therefore a
potential way for contamination of batches."
More recently, questions have been raised concerning
the potential risk from products where
heparin may have been used in manufacturing
or is present in the final product. These include
plasma-derived clotting factors and other
plasma-derived products such as immune globulins
and albumin. The FDA has advised that
these products are likely to be very low risk.
October 2008 www.ipec-europe.org 3

A look ahead to IPEC
Europe conferences
European Commission finalises changes to
radiopharmaceuticals GMP
Revised good manufacturing practice (GMP)
requirements for the production of radiopharmaceuticals
have been published by the European
Commission.
The updates to Volume 4 - EU GMP guide -
Annex 3 are intended to make it compliant with
GMP Part II, which laid out additional requirements
for active substances used as starting
materials. The aim is to provide the necessary
regulation to prevent cross-contamination, the
spread of radioactive material and ensure the
quality of the product.
Eye on Europe
EDQM notes deficiencies in Certificates of
Suitability
The European Directorate on the Quality of Medicines
has continued its efforts to improve the content
of applications for Certificates of Suitability
(CEP) for chemical purity.
To that end, the EDQM has issued a document
summarising the main deficiencies found in CEP
dossiers assessed between October and December
2007.
The documents list five top deficiencies and five
points that are not frequently appropriately documented.
The top deficiencies were:
IPEC Europe’s much anticipated Conference
on GMP for Excipients, will be held on 1-2
December 2008 in Munich, Germany.
This is a timely and critical conference, as
GMP has been brought to the fore in light of
public health cases where substandard quality
or counterfeited excipients have been
involved. And of course, the European regulatory
environment for GMP for ‘Certain Excipients’
remains up in the air.
IPEC Europe is delighted to welcome a prestigious
panel of speakers, including Sabine Atzor
of the European Commission, Katrin Nodop of
the EMEA, Bronwyn Phillips of the UK Medical
and Healthcare products Regulatory Agency
(MHRA) and Steven Wolfgang and Edwin Riviera
from the US Food and Drug Administration
(FDA).
They will be joined by a number of leading lights
from industry.
Excipients are also covered in the document,
which is due to come into effect by 1 March
2009.
As reported in the 'Documentation' section,
"Specifications should be established and documented
for raw material, labeling and packaging
materials, critical intermediates and the finished
radiopharmaceutical."
Samples of starting materials, excluding solvents
gases or water used in the manufacturing
process must be kept for at least two years after
the release of the product. This period can be
shortened if the material has a period of stability
of less than two years.
The full document is available here.
EMEA changes triethanolamine status in
veterinary medicines
The European Medicines Agency has added triethanolamine
to the list of residue substances
deemed not to have any pharmacologic activity
in veterinary medicinal products.
The list - Annex II of Council Regulation (EEC)
No 2377/90 - was drawn up to identify substances
for which requirements to meet maximum
residue limits (MRLs) do not apply. More
information can be found here.
Triethanolamine is used as an excipient in
creams, lotions and other topical preparations,
and serves as an alkalizing agent, emulsifier and
solubiliser.
Pharmeuropa 20.4 (October 2008)
published
The latest edition of EDQM’s quarterly Pharmeuropa
journal was published earlier this month.
It includes draft monographs and general texts
for comment by 31 December. The list of contents
is available here and it includes "Heavy
Metals 2.4.8".
O the absence of any discussion on genotoxic
impurities;
O the absence of any discussion on the carryover
of impurities/by-products from starting
materials;
O the absence of any discussion on benzene
as a contaminant in identified solvents;
O the absence of any discussion on for starting
materials from different suppliers; and
O absent information on the specifications of
the declared starting materials.
An earlier analysis was published on the EDQM’s
website in December 2006. Encouragingly,
“improvement has been observed in the quality of
the dossiers submitted since that time,” according
to the report.
The working document is available here.
As REACH deadline rolls ever nearer - are you ready?
With the deadline for pre-registration of chemicals
under the European Union’s new REACH
legislation coming up on 1 December, readers
are reminded that excipients and active pharmaceutical
ingredients are not necessarily exempt
from the process.
While APIs and excipients do not come under the
auspices of REACH - short for (Regulation for
Registration, Evaluation, Authorisation and
Restriction of Chemicals - they will need to be
pre-registered (and registered) if they are used in
any other applications, such as cosmetics.
Given the fragmented and frankly indefinable
excipient industry, that seems a tall order. Thankfully,
help is at hand.
CEFIC, the European Chemical Industry Council,
launched ReachLink, together with five national
chemical associations (France, Germany, Italy,
Spain, and the UK). The purpose of this project is
to assist companies in participating in the Substance
Information Exchange Forum (SIEF).
For more information on this unique conference
visit IPEC Europe’s website. The programme is
available as a pdf download.
In addition, the annual full-day IPEC Europe
seminar will be held at the Hotel Majestic
Barriere in Cannes on 22 January 2009. The
draft programme includes the following topics:
O Update on pharmacopeia objectives;
O Supply chain - import control in the US;
O GMP update and certification;
O Update on paediatric formulation; and
O Expectations and needs on excipient manufacturing
in relation to quality by design.
A Cocktail and Dinner will then be offered after
the main event.
SIEF’s aims are: data sharing for REACH registration;
collaboration between registrants on the
joint submission of data in the Technical dossier;
and, agreement on substance classification and
labelling.
Under REACH, around 30.000 substances have
to be registered by 2018 with ECHA, the European
Chemicals Agency. All companies importing
or manufacturing chemical substances in quantities
above 1 tonne have to submit registration
dossiers.
4 www.ipec-europe.org October 2008

IPEC Americas regulatory
affairs conference feedback
Eye on the world
Carl Mroz, chair of IPEC Europe’s Regulatory
Affairs Committee, attended the IPEC Americas
Regulatory Affairs Conference held in Alexandria,
US, on September 15-16.
FDA’s OGD offers to help firms comply with
residual solvents rule
The US Food and Drug Administration has
offered additional advice to generic drug manufacturers
to help them comply with the new US
Pharmacopeia standard for controlling residual
solvents, which came into effect on 1 July.
The FDA’s Office of Generic Drugs (OGD) has
made the move after seeing a lot of variability in
submitted applications. That in turn has led to a
number of deficiency letters regarding compliance
with chapter of the standard.
However, the FDA has interpreted this new
chapter in a way which many feel is inconsistent
with the intention of the USP and the ICH
guidance.
As a result an informal coalition of interested parties,
including IPEC Europe, has been formed to
address this issue directly with the FDA. The
coalition, which is coordinated by IPEC Americas,
had its first meeting with FDA on 10 October.
Additional details will be provided on this
important issue in future editions of Excipients
Insight.
The request implies that all generic companies
must be testing their excipients for residual solvents
and that excipient manufacturers must
include residual solvent specifications on their
Certificates of Analysis (CoAs).
As reported in the August-September Excipients
Insight, FDA published a draft Guidance
document for comment which advises on the
testing that is required. The OGD has published
a new document that provides additional
information on its own expectations.
This document helps clarify some issues but it
is not completely exhaustive.
The US Pharmacopeia has also published a
webpage that provides a portal for all relevant
information and resources available to help drugmakers
conform to the USP standard for residual
solvents here.
International Conference on
Harmonization
The International Conference on Harmonization’s
Steering Committee and Expert Working Groups
is scheduled to meet on 10-13 November. On
this occasion the conference will be held in
Europe (Brussels, Belgium).
A public meeting will be also held on 14 November,
to inform on recent developments at ICH
and to receive the latest news on hot topics coming
out of the working groups, to make and to
raise questions on quality , safety, standards
development and efficacy topics.
October 2008
Committee on Specifications for
Pharmaceutical Preparations
The World Health Organization (WHO) Expert
Committee on Specifications for Pharmaceutical
Preparations was scheduled to meet at the
WHO headquarters in Geneva, on 13-17
October, as this edition of Excipients Insight
went to press.
On the agenda for discussion are: quality control;
GMP; quality assurance; and guidance on paediatric
medicines. More information is available
here.
The following documents were circulated for discussion
in advance of the CSPP meeting:
O WHO Guideline on transfer of technology
A specific paragraph of the section on "production"
is dedicated to excipients.
O Recommendations for Improvement of the
WHO Certification Scheme on the Quality of
Pharmaceutical Products Moving in International
Commerce
Excipients are involved in the direct export from
manufacture to importing country, as well as
trade involving several manufacturers.
O Draft stability testing of active pharmaceutical
ingredients and finished pharmaceutical
products
This draft proposes that stability studies
should include the interaction of API with
excipients.
O Procedure for prequalification of medicinal
products
The procedure stipulates that specifications for
excipients should be submitted for the finished
product.
World Health Organization makes Ph. Int
available online
The World Health Organization has made the 4th
edition of the International Pharmacopeia (Ph.
Int.) available on its website.
The new library microsite contains the complete
text of the Fourth Edition of The International
Pharmacopoeia comprising Volumes 1 and 2,
published in 2006, as amended and augmented
by the text of the First Supplement, published in
2008.
www.ipec-europe.org
The headline event at the meeting was the presentation
of the final draft of the Excipient Qualification
Guideline (see article below).
Other topics included excipient functionality and
Quality by Design (QbD), with presentations from
both the US Pharmacopeia and the European
Directorate for the Quality of Medicines (EDQM).
There was much discussion on co-processed
materials and supply chain security. Copies of
the presentations are available here.
At the subsequent committee meetings progress
was made on the Excipient Information Package
and on the Excipients Composition Guide.
IPEC China chairman
elected
IPEC Europe congratulates Nevin Cheng of Colorcon,
who was recently elected chairman of
IPEC China. Cheng said in an interview with in-
PharmaTechnologist.com that IPEC China must
become a "harmonisation bridge between China
and other countries".
IPEC China has already brought multinational
excipient manufacturers and users like Colorcon,
FMC, Evonik, Dow Chemical and Pfizer into its fold
and has received ‘considerable’ interest from at
least four China-based manufacturers, said Cheng.
TriPEC
Meeting
The next TriPEC meeting will be held at the
ECCO premises in Brussels, Belgium, on 12-14
November. It will coincide with a TriPEC/Pharmaceutical
Development Group meeting that will
take place on 13 November. The meeting will be
followed by a dinner.
IPEC Excipient Qualification Guide
The final draft of the IPEC Europe / IPEC Americas
"Qualification of Excipients for Use in Pharmaceuticals"
Guide has been distributed for final
check and publication.
This document offers best practice and guidance
in the establishment of an effective relationship
between an excipient supplier and excipient
users. It concentrates on the issues that the two
parties are likely to encounter and offers advice
and best practice as to how to address them,
thereby ensuring a smoother relationship and
easier use of the excipient by the user and in
their dealings with the regulatory authorities.
5

Science and
Technology
Events calendar
Quality by Design for analytical methods for use with
orally inhaled and nasal drug products
The design of accurate and robust analytical
methodology is instrumental to developing orallyinhaled
and nasal drug products (OINDP).
Analytical methods generate data that determines
the selection of APIs and the screening
and selection of suitable excipients and container
closure systems that form the OINDP. They are a
key part of the quality management system that
underwrites the quality, safety and efficacy of
clinical and commercial products.
Analytical methods, including on-line
and in-line systems, monitor and
control the manufacturing process
for the API and finished OINDP,
and perform the required end
product specification testing.
The US Food and Drug Administration (FDA)
is seeking feedback from the pharmaceutical
industry to develop the recommendations of
the Nanotechnology Task Force.
The public meeting will be held in Maryland
on September 8 and those wishing to contribute
must register and submit an electronic
copy of their presentation by September 2.
Electronic comments may be submitted here
until October 24.
Given the concerns in some quarters over the
potential unintended effects of nanotechnology,
creating a comprehensive regulatory system
is seen as key to ensuring the safe implementation
of the technology.
Consequently the FDA is seeking the industry’s
views on: “The information and data that
may be needed to demonstrate the safety and
effectiveness of FDA-regulated products containing
nanoscale materials and the circumstances
under which a product's regulatory
status might change due to the presence or
use of nanoscale materials.”
In particular the FDA wants to specify what
characteristics of nanoparticles should be
used to evaluate their safety and the tools that
will be necessary to do so.
A Quality by Design (QbD)
development programme uses
a systematic approach that
utilises designed experiments
and multivariate
statistical tools to assemble
a product and process design space and,
where possible, link any defined critical parameters
to the demonstrated product safety and efficacy
Appropriate measurement systems will be
required to gain greater understanding of the
product and process, and to establish this
product and process design space.
The greater understanding, enhanced knowledge
and increased ability to control product
and process more efficiently, will ensure consistent
and high quality OINDPs, may help
gain regulatory flexibility and will facilitate continual
improvement.
A comprehensive method development programme
that generates the required analytical
knowledge to support the quality management
system and design space establishment is, therefore,
integral to this QbD effort.
This excerpt from a much longer article is reproduced
from Pharma Technology Europe with
grateful thanks.
FDA seeks help in refining nanotechnology
guidance
The FDA is also seeking information on the availability,
practicality and reliability of these tools and
has stated it will work with the industry to develop
new techniques if necessary. A detailed overview
of the manufacturing process is also being
sought, with the FDA keen to gain an insight into
any nuances unique to nanotechnology.
The challenge posed by scaling-up production
to commercial levels is one aspect the FDA
highlights. In addition the agency focuses on
the characteristics of nanoparticles that need to
be considered when developing “controls, standards
and specifications for manufacturing”.
Looking further along the supply chain the
FDA is seeking input into how storage may
affect the safety and efficacy of products containing
nanoparticles, including when they are
used as excipients. This will be used to
develop a policy for how products containing
nanoparticles need to be treated throughout
the distribution network.
Those contributing to the discussion are
encouraged by the FDA to raise any pertinent
issues that may have slipped the agency’s
attention.
This article is reproduced from in-Pharma-
Technologist.com with grateful thanks.
O FIP Workshop - Special dosage forms -
What's new with in vitro drug release?
London, UK
20-21 October
More info here.
O APIC Annual Conference
Paris, France
22-24 October
More info here.
O Heidelberg PAT Conference 2008 AND
Pre-Conference Workshops
Heidelberg, Germany
28-30 October
More info here.
O GMP and FDA compliant Quality and
Documentation Systems
Vienna, Austria
30-31 October
More information here.
O Implementation of Counterfeit
Protection Systems in the
Pharmaceutical Industry
Frankfurt, Germany
3-5 November
More information here.
O Pharmaceutical Water Systems
Vienna, Austria
4-6 November
More information here.
O ICH Steering Committee and Expert
Working Groups meeting
Brussels, Belgium
10-13 November
More info here.
O Public ICH meeting
Brussels, Belgium
14 November
More information here.
O IPEC Europe GMP Conference
Frankfurt, Germany
1-2 December
More info coming soon here.
O 6th Edition European Pharmacopoeia
Training Session
London, UK
11-12 December
More information here.
6 www.ipec-europe.org October 2008

Excipient
industry
news
round-up
IPEC Europe members are welcome to submit articles for publication in this section here.
Pfizer’s API unit to use
Prosonix' Prosonitron
Prosonix, a specialist developer of ultrasonic
industrial processing solutions, says that global
drug giant Pfizer is to begin using its Prosonitron
reactor and sonocrystallisation technology at its
manufacturing facility in Ireland.
Crystallisation, which is among the most commonly
used separation and filtration techniques
in the drug industry, is an extremely complex
process that is dependant on a disparate range
of hard-to-control variables.
Novozymes wins gold with
hyaluronic acid
Novozymes Biopolymer won the coveted Gold
Innovation award at this year’s CPhI exhibition in
Frankfurt, Germany, for its hyaluronic acid (HA)
product HyaCare.
HyaCare was developed to serve a wide range
of solubility applications in the pharmaceutical
sector. It is the world’s first HA product made
without animal-derived raw materials and organic
solvents, so has a more favourable safety profile
than traditional HA products.
Dow working to restore PEG
capacity after hurricanes
Dow Chemical is hoping to push production of its
Carbowax Sentry brand of polyethylene glycol
ingredients up by a third over 2006/2007 levels
by the end of the year, and put the production
problems of recent months behind it.
The company is still struggling to restore capacity
hit by the twin impacts of hurricanes Gustav and
Ike earlier this year, which together affected more
than 50 per cent of its PEG production.
The effects of Hurricane Gustav, which made
landfall on the Louisiana coast on September 1,
were direct. Dow operates its two PEG production
plants in the state, one (St Charles) just outside
New Orleans, and the other at Plaquemine,
about 100km north of the city. While neither suffered
significant damage in the storm, both were
affected by power outages lasting almost three
weeks.
Hurricane Ike, which made landfall in Texas two
weeks later, had both direct and indirect consequences.
Dow’s own plants had to shut down
because of power and utility problems. But damage
to the wider Texas petrochemicals industry
has caused significant interruption in supply of
the raw materials – ethylene and ethylene oxide
feedstock - needed to make PEG.
Prosonix’ technology uses power ultrasound to
tightly control the process, enabling the precise
production of high purity organic and inorganic
microcrystalline chemicals.
The system, which can be applied to both excipients
and active pharmaceutical ingredients
(APIs), is designed to lower manufacturing costs,
increase productivity by reducing batch failure
and improve safety of operations.
Under the supply agreement, financial terms of
which are not being released, Pfizer will use the
Prosonitron system to improve the crystallisation
of a number of APIs as part of its ongoing efficiency
drive.
This excerpt of a longer article is provided
courtesy of www.in-PharmaTechnologist.com.
Beneo-Palatinit introduces
filler/binder granulation agent
Beneo-Palatinit GmbH has extended its range of
galenIQ bulk excipients, launching a new grade
for granulation at the CPhI exhibition in Frankfurt.
galenIQ 801 is a high-solubility refined powder
grade that extends the capability of the 800
series to include formulation of tablets, sachets or
dry powder syrups. It is particularly suited to wet
granulation, compaction and other agglomeration
processes.
The new excipient can be processed in standard
aqueous or ethanolic granulation processes, and
the final granulates and agglomerates exhibit
high mechanical stability and very good flow
properties, according to the firm. galenIQ 801 is
GMO-free and non-animal in origin, made from
sucrose in a two-stage production process.
The company said it is building a GMP facility to
boost production capacity for hyaluronic acid and
will be offering a full ICH Q7A validated manufacturing
process.
ISP adds to range of
pharmaceutical coatings
International Specialty Products extended its portfolio
of polymer coatings with the launch of a new
range, Advantia Preferred HS, intended as immediate-release
films for oral solid dosage forms.
The coatings are based on polymers and plasticisers
and can be applied in up to 35 per cent
high-solids suspensions. High-solids coating formulations
reduce coating process time and can
be cheaper than other approaches. ISP says its
new range provide a smoother finish than other
high-solids coating systems.
Studies have shown that the new coatings do not
slow down tablet disintegration and dissolution,
according to the firm.
Univar’s chlorhexidine
gluconate gets CEP
Univar introduced a chlorhexidine gluconate
product at the CPhI exhibition which is certified
by the EDQM with a certificate of Suitability
(CEP). The comany also has a Drug Master File
for the ingredient.
Chlorhexidine gluconate is a disinfectant and
antiseptic used in oral care, skin care, cosmetics
and pharmaceutical products, commonly used in
mouth washes, surgical scrubs, hand washes
and teat dips. Univar’s product is manufactured
by R.N. Pharmaceuticals.
PEGs are used in hundreds of pharmaceutical
applications as excipients, said Tom Frazier,
global marketing manager for Dow’s polyglycols
and surfactants business
This excerpt of a longer article is provided
courtesy of www.in-PharmaTechnologist.com.
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Editor: Phil Taylor
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Excipients Insight
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October 2008 www.ipec-europe.org 7