International Pharmaceutical Excipients Council ... - IPEC Europe

International Pharmaceutical Excipients Council Europe 

April 2003 IPEC Europe News 

Contents 

A Journey to the Centre of the Earth… .......… .1,2 

IPEC position papers: Purpose and content 

of a compendial monograph .… …………………2 

IPEC Europe … ………………..… ………….… ….3 

Member profiles Akzo Nobel … …….… . .… ……4 

Good Distribution Practices… ……………………5 

Luzenac: talc for the world… ……………….… 5 

Enlargement of the European Union: 

Hungary… ………………………………………….6 

Meetings and Congresses… ….… …. … ……..... 8 

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International Pharmaceutical 

Excipients Council Europe 

Henk de Jong 

Chairman IPEC Europe 

Servier 

6, Place des Pleiades 

92415 Courbevoie 

France 

Tel +33-1-5572 6178 

Fax +33-1-5572 7671 

E-mail: hendrik.dejong@fr.netgrs.com 

Evert Izeboud 

Executive coordinator to IPEC Europe 

Kerkweide 27 

2265 DM Leidschendam 

The Netherlands 

Tel +31-70-320 9894 

Fax +31-70-320 3759 

E mail: eizeboud@worldonline.nl 

Internet: http://www.ipec.org/europe.htm 

Editorial 

A Journey to the Centre of the 

Earth 

Henk J. de Jong 

Even Jules Verne when publishing his novel: 

« Voyage au Centre de la Terre » in 1864, 

with all his fantasy and imagination did not 

predict that delegations from IPEC-Americas 

(Chris Moreton, Janeen Kincaid) and IPEC- 

Europe (Undine Kettenring, Henk de Jong) 

would participate by invitation from their 

JPEC colleagues (Mrs. Kijima, Watanabe, 

Kokubo, Myamoto and Saisho) in an 

excursion to the Centre of the Earth. 

This trip took place between the Tri-PEC 

and the Tri-PEC / PDG meetings in a 

recently build volcano at Tokyo-Disney, 

close to the venue for the ICH and PDG 

meetings held in early February 2003. 

The highlights from our meetings are 

reported briefly here : 

- Since the harmonization effort (first round) 

is reaching 49 out of 51 (harmonization by 

attributes), a new priority rating for 

additional monographs was discussed. 

PDG will inform Tri-PEC about the 

programme and the choice of the 

coordinating Pharmacopoeia for each 

proposed new item. 

- PDG has accepted to indicate clearly in 

future editions of their respective books 

which parts of monographs are 

harmonized. USP and Ph. Eur. will do this 

by printing a distinctive sign (a lozenge) in 

the margin. JP will publish a general 

chapter explaining the situation. 

(to be continued on page 2)


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(continued from page 1) 

- Round Robin testing to resolve « sticking 

points ». 

The effort on Anhydrous Dibasic Calcium 

Phosphate last year was full of mysteries. A 

new protocol was written and procedures 

clearly defined in a step by step way. 

Tri-PEC Lunch at the "Centre of the Earth" 

- Interchangeability of « equivalent » 

methods. 

Tri-PEC insisted a lot on having 

interchangeability « declared » in the 

framework of harmonization. PDG has 

the opinion that acceptance of 

interchangeability is with the regulatory 

authorities. Both PDG and Tri-PEC will 

work on clarification of this important 

point e.g. IPEC-Europe with Ph. Eur. and 

EMEA / QWP. 

- Impurity Guidance 

IPEC-Americas and IPEC-Europe will 

strive for a common guidance to address 

their members’ need. Once a draft is 

available it will be shared with JPEC. 

- The Common Technical Document will 

have an impact on all new submissions. 

Undine Kettenring and Henk de Jong will 

collect experiences with CTD 

submissions and organise (part of) a 

seminar on this. 

- IPEC-Americas have asked for input as 

to what are the preferred sieving 

methods in Europe and Japan. Please 

provide feed back to 

undine.kettenring@pharma.novartis.com 

P.M. the USP methods are : Dry 

Sieving, Wet Sieving, Alpine Edger, 

Sonic Sifter. 

- The pharmacopoeial fora will publish 1) 

the article of Andersson et al. on NMR 

determination of hydroxypropoxy content 

in HPC and 2) the policy paper on the 

purpose of excipient monographs. Both 

articles did appear in the April issue of 

Pharmeuropa (15.2). 

- The International Non proprietory 

Names (INNs) for excipients do 

unfortunately not have a high priority 

among Tri-PEC and PDG. Chris 

Moreton and Henk de Jong will, through 

a step by step approach, try to make 

some progress directly with WHO. 

- PDG promised to define and transmit a 

list of outstanding « Sticky points) where 

Tri-PEC could help to find solutions. 

As you will have noticed from the above, this 

trip to the core of the world was full of 

surprises and lucky escapes, thus : we 

survived and decided to engage in the next 

Tri-PEC / PDG / meeting : Brussels July16, 

2003 

IPEC position papers 

The purpose and content of an excipient 

monograph(1) 

During the past two years a lot of work has 

been done by the three IPEC associations 

on elaborating a position paper on the 

purpose and contents of a compendial 

monograph for pharmaceutical excipients. A 

summary of the essentials of the position 

paper is given below, while the whole text 

will be published in the Pharmacopoeial 

Fora in Japan, The United States and 

Europe (Pharmeuropa, 15.2, April 2003). 

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April 2003 2 IPEC Europe News 

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Implementation of the contents of this 

position paper in the pharmacopoeial 

compendia will contribute significantly to the 

practical application of the monographs, i.e. 

a guarantee of the quality (assurance) of 

pharmaceutical excipients combined with a 

balance in the mandatory and non 

mandatory parameters of the monographs. 

Summary of the position paper 

Monographs for excipients should be 

designed to ensure the safe use of these 

materials when used in pharmaceutical 

preparations. Criteria should also be defined 

to give consistent quality. Hence in addition 

to requirements for identity and purity (limits 

for harmful or destabilizing impurities), 

functionality-related properties should be 

considered. 

Functionality related properties for a specific 

excipient may vary for different medicinal 

products. Therefore no binding limits for 


included in a pharmacopoeial monograph. 

Functionality-related property testing should 

be not be-mandatory. It should be reported 

in the product labelling, with reference to the 

test method used. If available a general 

method described in a pharmacopoeia is 

preferred. Any limits for relevant 


agreed between the user and the supplier. 

IPEC Europe 

Evert Izeboud 

An important organisational event in 2002 

was the establishment of a standing 

committee for internal and external 

communication matters. Various preparatory 

meetings have resulted in a communication 

plan which was presented by Mr Herman 

Ermens during the Annual General Meeting 

on January 31 st 2003. The communication 

plan will focus on refreshing of the face of 

IPEC Europe in terms of a consistent house 

style and establishing of a professional 

public relations policy (excipients articles, 

press releases etc). This effort will also 

relate to the presentation of IPEC Europe’s 

Newsletter. Articles will be published on the 

company profiles of IPEC Europe members, 

starting in this issue with Akzo-Nobel. 

IPEC Europe Board 

Mr Adrian Bone was elected to serve as a 

member of the IPEC Europe Board at the 

meeting held in Amsterdam in January. 

2003. Adrian, a registered pharmacist is an 

employee of Eli Lilly and Company based in 

the UK where he has held many positions in 

Lilly's Quality component in several 

countries, spanning a career of over 20 

years 

Dr Adrian Bone, 

IPEC Europe Board member 

Adrian is currently a Manager in the 

company's Corporate Quality Assurance 

Division, with a specific responsibility for the 

quality standards associated with in-coming 

components (which includes excipients). At 

the moment, he is involved in an interindustry 

group considering the possibility of 

sharing vendor audit reports. 

(to be continued on page 4) 

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( continued from page 3) 

This concept offers significant advantages to 

both pharmaceutical companies and 

suppliers but also considerable challenges 

when issues such a auditor consistency and 

liability are considered. Adrian has been part 

of industry groups and committees covering 

a wide range of subjects, including drafting 

the Pharmaceutical Quality Groups' 

monograph PS 9000:2001 - Pharmaceutical 

Packaging Materials. 

More recently he has been involved in PERF 

II (Pan European Regulatory Forum) and the 

issues facing candidate countries applying to 

join the EU in 2004. 

IPEC Europe membership 

The year 2003 started with a number of 

mergers/take overs which affected the IPEC 

Europe membership. Avebe’s excipients 

business was acquired by DMV International 

while Pharmacia now is part of Pfizer. Due 

to a reorganisation in business orientation 

Royal Cosun (Netherlands) has terminated 

its membership. 

In February 2003 the Board endorsed the 

application of Luzenac the worlds largest 

supplier of talc. An article on Luzenac is 

published on page 5 of this newsletter. 

During the Board meeting on April 11 th 2003 

the application of the French company SPI 

Pharma was endorsed. The company profile 

of SPI Pharma will be published in the July 

Newsletter. 

The IPEC Europe membership currently 

counts 68 full members, 4 associated 

members and 1 co-opted member. 

IPEC Europe membership profiles 

Under the heading Membership profiles an 

attempt will be made to inform the IPEC 

Europe membership about the major 

activities (Excipients) of the members. A 

start will be made with Akzo-Nobel a maker 

of pharmaceutical excipients. 

Akzo-Nobel based in the Netherlands, 

serves the customers throughout the world 

with healthcare products, coatings and 

chemicals. Akzo-Nobel is one of the IPEC 

Europe members which manufacturers the 

excipient Sodium Carboxymethylcellulose 

(EP: Carmellose Sodium) , which finds 

applications in key market sectors such as 

pharmaceutical and food products. 

Carmellose Sodium can act as a thickener 

and stabilizer, but also as a moisture binder 

and gelling agent. Carmellose Sodium is 

widely used in oral and topical 

pharmaceutical formulations primarily for its 

viscosity-increasing properties. Viscous 

aqueous solutions are used to suspend 

powders intended for either 

topical application and oral and parenteral 

administration. Carmellose Sodium may 

also be used as a tablet binder or 

disintegrant, and or to stabilize emulsions. 

Specialty grades are available to produce 

gels which can be used as a base for 

various applications. Carmellose Sodium is 

additionally one of the main ingredients of 

self-adhesive ostomy, wound care, and 

dermatological patches where it is used to 

absorb wound extrudate or transepidermal 

water and sweat. 

Akzo Nobel 

Representative to IPEC Europe 

Mr Theo van ‘t Zelfde 

Tel: +31-33-467 6757 

Fax +31-33-467 6118 

E-mail: Theo.vantZelfde@akzonobel.com 

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Good Distribution Practices (GDP) 

Frank Milek 

IPEC Europe´s Good Distribution Practice 

Committee prepared together with IPEC 

Americas a draft document entitled 

“Guidelines on Good Distribution Practices 

(GDP) of Bulk Pharmaceutical Excipients”. 

As presented at the IPEC Europe Annual 

Meeting (31.01.03) in Amsterdam, this draft 

had been elaborated during the last year. It 

is a complementary document to the “IPEC 

GMP Guidelines for Bulk Pharmaceutical 

Excipients”. The present draft also takes into 

account the ideas of WHO’s "Good Trade 

and Distribution of Pharmaceutical Starting 

Materials" (GTDP) document, CEFIC´s 

"Guidelines for the Distribution of Propylene 

Glycol EP/USP", CEFIC/FECC "European 

Single Assessment for Chemical 

distributors" and the commonly recognized 

necessity to define some Good Practices for 

the global distribution of excipients 

especially in case of repackaging and 

relabeling activities carried out through the 

supply chain. The main aims of these GDPs 

are to ensure full traceability and to avoid 

any contamination or adulteration of 

excipients through the supply chain of 

excipients, which is in the best interests of 

the excipients manufacturers and users. 

This draft document has been distributed to 

the whole IPEC Europe membership for 

comments And several comments have 

been received to date. During future 

meetings the Committee will revise the draft 

taking the members comments into account. 

Furthermore it is intended to work closely 

together with IPEC Americas. And indeed 

the Committee is waiting for comments from 

IPEC Americas on the current draft. 

On March 10-14 th 

the WHO Expert 

Committee on Specifications for 

Pharmaceutical Preparations met in 

Geneva, where the Expert Committee 

accepted the current draft of the working 

document on "Good Trade and Distribution 

Practice for Pharmaceutical Starting 

materials" (QAS/01.014/Rev2). The draft 

now will only be reviewed by WHO editors 

and before final approval by the WHO 

Executive Board (A group of UN 32 member 

states) in January 2004. The document will 

then be officially available for publication. 

Therefore some slight changes of the 

wording are possible. This document is inline 

with IPEC´s activities on GDP for 

excipients, e.g: 

- Traceability back to the original 

manufacturer throughout the whole supply 

chain 

- No up-grading of non-pharmaceutical 

grade to pharmaceutical grade material 

- Appropriate standards for repackaging and 

packaging materials 

- Appropriate requirements for quality control 

and Certificates of Analysis 

- Appropriate measures against crosscontamination 

FECC´s (European Association of Chemical 

Distributors Associations) GMP-Committee 

is working on an official position of the 

association on Good Distribution Practice of 

Pharmaceutical Starting Materials. They see 

the necessity of improvement and want to 

adapt the above mentioned WHO GTDP as 

the basis of their work and official position. 

These different activities on GDP are 

highlighting the importance of this topic for 

the supply chain of pharmaceutical starting 

materials. The outcome of the different 

activities will be reported in future IPEC 

Europe Newsletters. 

Luzenac Group is the world's number one 

talc producer, with over thirty mines and 

processing plants in Europe, America, 

Canada, Mexico and Australia. As leader, it 

is committed to setting the standards for the 

talc industry in such areas as innovation, 

technical assistance, product quality, health 

safety and environment, and ethical 

behaviour.With the widest talc product range 

and significant applications expertise, 

Luzenac is the only talc producer that can 

meet all end-use requirements worldwide. 

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The Group produces over 1.4 million tonnes 

of talc and talc-related minerals a year and For Additional Information on Talc 

serves some 10,000 customers worldwide, 

in industries as diverse as coatings, paper, Luzenac Europe 

plastics, ceramics, rubber, animal feed and BP 1162 31036 Toulouse Cedex 1 

personal care. 

France 

What is talc ? 

Talc is our planet’s softest mineral. It is a 

hydrated magnesium silicate 

(Mg 3 Si 4 0 10 (0H) 2 ). Although talcs differ 

slightly according to the associated minerals 

present in the ore-body, all talcs exhibit to a 

lesser or greater extent the following unique 

features: softness, hydrophobicity, 

inertness, platyness, and organophilicity (an 

affinity for certain organic chemicals). These 

properties provide specific functions in a 

whole range of applications. 

Luzenac has reached its current status 

through a high rate of new product and 

application innovation. Luzenac’s philosophy 

is to provide customers with innovative 

products and services while operating to the 

highest health, safety and environmental 

standards. 

Luzenac’s mountain-top mine in the 

French Pyrenees 

Dr Didier Arseguel 

Representative to IPEC Europe 

Tel +33-561 562020 

Fax+33-561 502000 

E-mail: didier.arseguel@europe.luzenac.com 

Enlargement of the European Union 

On April 16 th 2003 important progress was 

made with regard to enlargement of the 

European Union: a treaty was signed off by 

candidate member states to join the European 

Union in 2004. IPEC Europe’s Communication 

Committee has decided to publish small 

articles with, where possible, an overview of 

the consequences for the market possibilities 

for pharmaceutical excipients. This Newsletter 

focuses on Hungary, a candidate EU member 

with a significant pharmaceutical industry. 

Hungary 

Source: 

Hungarian Ministry of Economic Affairs 

The Hungarian pharmaceutical industry plays 

a highly important role both in the economy 

and in health care provision. It has a tradition 

of more than 100 years and is one of the most 

competitive branches of the Hungarian 

industry. Its share of the gross value of 

industrial output was 2.4 per cent in 1998. 

However, the significance of the sector is 

much greater than the quantity figures 

suggest, if the innovative and structural 

modernization efforts are also taken into 

account. Hungarian pharmaceutical 

companies contributed significantly to the 

progress of the sector, by investing HUF 81 

billion in it in general and HUF 41 billion in 

research and development in the period 

between 1994-1998. 

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The companies of the pharmaceutical sector 

are engaged in the production of the following 

product categories: human pharmaceuticals 

(including active ingredients and finished 

drugs), veterinary medicines, fine chemicals, 

intermediates of pharmaceuticals and 

pesticides, insecticides, laboratory chemicals 

and diagnostic products, as well as vitamin 

containing food supplements and 

paramedicines. Several pharmaceutical 

companies run other lines of business (e.g. 

cosmetics); however, pharmaceutical 

products play a decisive role both in 

production and strategic development. 

The pharmaceutical market can be divided 

into 3 large product categories. The largest 

one consists of prescription-only, patented 

pharmaceuticals with a registered name.The 

second group is made up of over- the-counter 

(or OTC) drugs - these products are sold in 

pharmacies but do not require a prescription. 

Typical drugs belonging to this group include 

analgesics, laxatives, products against sore 

throat and other minor infections, and 

vitamins. The third group consists of the socalled 

generic products. These products have 

the same active ingredient and quality as the 

originals but being off patent, they are priced 

much lower and often do not have a brand 

name. Beside medicines, paramedicines and 

natural substances that cannot be patented 

are also produced as generics. 

Major player in the market 

There are four Hungarian manufacturers 

among the top ten companies that account 

for almost half of the domestic sales of 

pharmaceuticals. Richter Gideon Rt is the 

largest pharmaceutical company in Hungary 

manufacturing about 100 preparations in 

140 dosage forms and pack sizes. These 

products cover the most important 

therapeutic fields and most of them have 

been developed by Richter itself. The 

success of research and development 

activities are shown by the fact that almost 

one-fourth of the total sales is generated by 

products originating within the company. 

Richter sells about two-third of its production 

on foreign markets. Richter has especially 

strong presence in Eastern Europe , where it 

is the largest foreign supplier of 

pharmaceuticals. 

3 rd International Symposium on 

Excipients 

The 3 rd International Symposium on 

Excipients for non-parenteral Dosage Forms 

is arranged by the Swedish Academy of 

Pharmaceutical Sciences in co-operation 

with IPEC Europe. 

The symposium is intended for people 

concerned with design, production and 

quality assurance of pharmaceutical dosage 

forms. Mr Henk de Jong is a member of the 

organizing Committee and will present a 

lecture on “Considerations relating to the 

development of novel excipients” 

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Meetings and Seminars 2003 

Calendar of Meetings and Seminars 

May 12 th and 13 th 

Drug Information Association 

Active Pharmaceutical Ingredients and 

Starting Materials , Rome, Italy 

June 1 st - 4 th 

United States Pharmacopeia 

Analytical Methods and General USP 

topics 

Philadelphia, United States 

July 4 th 

IPEC Europe Board Meeting 

Paris, France 

September 8 th and 9 th 

Swedish Academy of Pharmaceutical 

Sciences 

3 rd International Symposium on 

Excipients for non-parenteral dosage 

forms. 

Stockholm, Sweden 

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Next IPEC Europe Newsletter 

The next Newsletter is scheduled to be 

issued in the month of July 2003. 

Call for text to be published 

IPEC Europe members who would like to 

contribute to the Newsletter are invited to 

submit text electronically (maximum 1 A4) 

to Mr Izeboud. 

IPEC Europe on the Internet 

http://www.ipec.org/europe.htm 

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