Cypriot Pharmaceutical Manufacturers Facing Exciting But Challenging Times rev 1

							    Cypriot Pharmaceutical Manufacturers Are Facing Exciting But Challenging Times


                                                 David R Buckley1


Cyprus strategically positioned


Strategically positioned close to the Middle East and Africa and within easy reach of the Far

East, Cyprus is in a unique position to exploit its position in Europe with respect to the

manufacture and distribution of pharmaceuticals. From Australia to Costa Rica, from

Lebanon, and the Gulf countries in the Middle East, from the UK to Kenya, Ethiopia and

other African countries, and all across Asia and the Pacific, Cypriot pharmaceutical

manufacturers are exporting pharmaceutical products all over the globe, making “Made in

Cyprus, made in EU” synonymous with Quality.


In over seventy countries all over the world, and of course in Cyprus, consumers are using

and trusting Cypriot-made pharmaceuticals which have demonstrated consistent excellence

and conformance to internationally approved quality standards.


How did this come about?


By the commitment and dedication of the hardworking staff of the Pharmaceutical Services

in the Ministry of Health, which over the last decade oversaw the introduction of the

necessary changes to Cypriot law and factory standards to ensure it and the industry was

ready for the Cypriot accession to the EU. These changes aligned the law with the European

Directives, saw additional personnel recruited into the PSS and saw changes in the way

inspections were carried out. With the Pharmaceutical Services working synergistically with

the industry these changes in the pharmaceutical infrastructure also saw approval by Health

Canada which now allows Cypriot pharmaceuticals to be exported to Canada without further

inspection or testing. It should be noted that the Canadian National Regulatory Authority


1
 David Buckley & Associates Pty Ltd, 7 Catani Place, Monash, ACT 2904, Australia, Phone/fax (61) 2 62914626,
www.navigategmp.com
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carried out its lengthy 13 month due diligence review after Cyprus joined the EU, and it

confirmed that the standards achieved by Cyprus regulators and industry alike were world-

class.


This was not the only regulator from a highly regulated market that has affirmed Cyprus laws

and manufacturing standards, as Cyprus is poised on the 1st of July to enter the

Pharmaceutical Inspection Convention Scheme, usually referred to worldwide as “PICS”.

This exclusive club has 30 or so member countries whose industry and regulators undergo

close scrutiny by the elite peer group before entry is permitted. Entry into PICS will without

doubt facilitate even more the acceptance of Cypriot-made pharmaceuticals by non-PICS

countries, which hold PICS membership as a symbol of quality manufacturing, as well as

those non-EU PICS members which could still carry out their own inspections but now can

rely on the reports of the Pharmaceutical Services.


It can be seen that Pharmaceutical Quality is a collective responsibility of industry and

government working in harmony.


This has been assisted by Cyprus’s unique regulations concerning training whereby

manufacturers pay into a training fund run by the Human Resource Development Authority,

which is responsible for its activities to the Ministry of Labour. It is to be applauded that the

government has the foresight to provide an Authority which can set up these programmes

with this level of assistance to industry.


It must surely be the envy of other countries’ regulators and industry. The fund is used to

support training for industry personnel including training provided by external training

organisers, such Quintessence Enterprises Ltd2, which provides consulting services and

offers seminars to companies. Without a doubt these seminars would be impossible or very

difficult to run without this government backed program, alternatively, it would be difficult to

2
 Kennedy Business Centre, 12-14 Kennedy Ave., Office 208, 1087 Nicosia. Telephone: 22466500, Fax: 22560260, E-mail:
quintessence@cytanet.com.cy, Website: www.quintessence.com.cy
Cypriot Pharmaceutical Manufacturing rev 1                                                                    Page 2
recruit overseas experts with sufficient experience to provide information on the ever

changing global regulations and their interpretation.


Evis Hadijicostas, the Quintessence director, seeks out overseas experts with international

experience at the highest level to provide this training. Evis recently organized the second

annual seminar on GMP issues which addressed the advanced Good Manufacturing

Practices now required by pharmaceutical companies in Cyprus.


The Advanced GMP training course was conducted by David Buckley, a well known GMP

expert with an international reputation who has visited Cyprus many times since 2000. The

seminar was attended by participants from both government and industry and it covered

(among many topics) theoretical and practical cost effective approaches to Quality Risk

Analysis and Management, Advanced Clean Rooms, the changed EU rules on Sterile

products manufacturing, Statistical Process Control, Process Validation and Computer

Validation, and Advanced Water Systems.


Company visits


The seminar was followed up by visits to all the companies who had sent participants to

answer in confidence specific questions and to provide one-to-one training in some cases.

For example, the participants were given the opportunity to “test drive” some of the many

statistical software packages that can perform the mandatory statistical analysis now

required to demonstrate pharmaceutical process capability.


Many of them found much satisfaction when they realised that basic statistical analysis could

be easily mastered, and were delighted with the software’s ability to visualise complex data,

and to be able to copy and paste into reports which gave them very professional

appearance.


These visits were in fact so very enthusiastically received that they invariably ran over time

such was the eagerness of the industry participants to learn firsthand the complexities of the
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stringent rules designed to ensure high quality pharmaceuticals demanded by the

international pharmaceutical customers.


The companies visited were, in order of the visits:


PHADISCO Ltd3, officially established 1966, is one of the leading pharmaceutical companies

which, however, began operating in 1933 in the consumer healthcare market. It specializes

in the representation of many, many well know pharmaceutical and medical brand names, as

well as under its own brand name. According to the type of product Phadisco distributes

directly or through its affiliate, Pharmalink Ltd, to mainly to pharmacies, hospitals and

laboratories.


REMEDICA Ltd4 founded in 1980 is another leading pharmaceutical company dedicated to

the development, production and sale of high quality generic pharmaceutical products in

wide range of therapeutic categories. Remedica's three principles commitment is to quality,

service and value. Remedica exports to more than 70 foreign markets, including countries of

the European Union, Central and Eastern Europe, the Far East, the Middle East, and Africa.


AEGIS PUBLIC LTD5 was established in 1989, and produces over 100 high quality

pharmaceutical products at affordable prices which are sold to over 30 countries. It’s

performance criteria are an unswerving dedication to ethical conduct in all its endeavours,

and to a strong formal program for its promotion, implementation and measurement. Its

strategy is to offer drugs therapeutically equivalent and interchangeable with the products of

the industry leaders, at fair prices.




3
  Phadisco - 185 Yiannou Kranidioti Avenue, CY-2234 Latsia, PO Box 22173 CY-1518 Cyprus Telephone: +357-
22-715000
Fax: +357-22-715100
4
  Remedica - Limassol Industrial Estate, P.O. Box 51706, CY-3508 Limassol, Cyprus Tel: +357 25 553 000
Fax: +357 25 390 192
5
  Aegis - 17, Athinon Street, Ergates Industrial Estate, PO Box 28629, CY-2081 Nicosia, Cyprus
Cypriot Pharmaceutical Manufacturing rev 1                                                        Page 4
LINDE HADJIKYRIAKOS GAS LTD6 is a producer of compressed gases. Its range of

Medicinal gases are used as therapies for patient care both within hospitals and clinics as

well as in homecare. In patients with severe asthma and Chronic obstructive pulmonary

disease, oxygen may be needed 24 hours a day over the patient’s lifetime. Accordingly

Linde Hadjikyriakos Gas has a very high regard for Quality assurance, regarded as critical

for users who rely on it to sustain their lives.


VOGEN LABORATORIES LTD7, in operation since 1985, is a boutique antibiotic

manufacturer with manufacturing and marketing authorisations for oral solid penicillin

dosage forms. They have a keen and enthusiastic workforce with a dedicated desire to re-

establish the company in the field of other antibiotics, anti-inflammatories, antiseptics. It

exports over 95% of its production to many regions number of overseas markets and is

seeking serious wholesales, importers, distributors all over the world.


MUNDIPHARMA PHARMACEUTICALS 8 in Cyprus is part of the global operations in 113

countries, with its pharmaceutical products being primarily branded ethical medicines. The

main medical items are Analgesics, Antiseptics (being the world market leaders for povidone

iodine preparations) and Respiratory Preparations, with particular expertise in drug delivery

systems for analgesics, respiratory treatments and cardiovascular drugs.


PREMIER SHUKUROGLOU LTD9 in operation since 1966, it is active in the crop protection,

animal health, public health and industrial chemicals and it owns and operates a modern

formulation plant for crop protection products. Amongst the critical-care products it makes is

Ectoparasiticide for the control of ectoparasites (that is; lice, keds, ticks and flies) that infest

sheep, goats and cattle.


6
  Linde - 260 Limassol Avenue , CY-2029 Strovolos Nicosia, CYPRUS, Tel: +35722 482330, Fax: +35722
487787
7
  Vogen - PO Box 53520, 3303, Limassol Cyprus, Tel: +357 25729066, Fax: +357 25727209
8
  Mundipharma - 13 Othellos Street, 1685 PO Box 23661 Nicosia, Tel: +357 22488010 Fax: +357 22487833
9
  Premier - 1, Trikoupi Street, PO Box 12508, 2250-Latsia, Cyprus, Tel: +357 22759400, +357 22815353, Fax:
+357 22482331
Cypriot Pharmaceutical Manufacturing rev 1                                                            Page 5
So what are the challenges?


    1. To keep current with the ever changing application of rules and regulations imposed

        by the obligations of being a EU member country by grabbing every opportunity to

        meet and speak to overseas experts.


    2. To take control of the opportunities provided by PIC/S and EU accession by investing

        in Cyprus pharmaceutical infrastructure and its well educated, dedicated and

        motivated work force.


    3. To take full advantage of the training opportunities provided by training service

        providers who can realise the full assistance from the Human Resource Development

        Authority.


    4. To ensure the well educated, dedicated and motivated work force are always

        provided with the opportunity for continuous education, by utilising both internal and

        external training courses, whenever the opportunity is provided.


    5. For the Pharmaceutical Services, to provide a fearless yet synergistic, high level

        surveillance of the pharmaceutical industry to ensure the obligations of PIC/S

        membership and EU accession are not endangered. To achieve this it will be

        necessary to utilise to full advantage the training provided by PIC/S and to

        supplement whenever possible by utilising overseas experts for in-house training

        whenever they visit Cyprus.


    6. By the government and industry continuing to support the Human Resource

        Development Authority, who have a vital role to play in ensuring Cypriots training and

        professional development is second to none in the world.




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