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Good Distribution Practices – All you need to know

Maintaining high standards in good distribution practice will ensure that Ireland remains a leading international location for the life sciences industry, write Raul Molina and Ciaran Brady.

In the pharmaceutical industry, good distribution is not just a case of guaranteeing that a patient’s supply of medicine is made available on time when needed, it is a case of ensuring that the entire supply chain and distribution network is focused on supplying a quality product that complies at every point with regulatory requirements and is fit for use when it reaches the patient. Any failings within the pharmaceutical supply chain can seriously compromise the quality of the product and hence patient safety.

In this context, the supply chain extends well beyond the vehicles used to take bulk pharmaceutical (such as APIs) and medical components to the manufacturing facility and finished products from the manufacturing facility to distributors/wholesalers. It also must ensure compliant delivery to hospitals, pharmacies and even supermarkets where patients receive their medicines. We all, as patients, would like to know that the excellent quality under which medicines are made in the manufacturing facility extends all along the legitimate supply chain and we and our families are always safe.

Good distribution practice (GDP) is about much more than just the distribution of products. The MHRA (the UK authority) recently defined GDP as “the sum of all of the processes and activities designed and implemented to ensure that the quality of medicines is maintained throughout the distribution chain from manufacturer to patient, ensuring compliance with regulatory requirements at all relevant stages. It includes the storage and transportation of APIs, other ingredients and packaging components used in the production of the medicines.”

In effect, GDP extends to sourcing materials from approved suppliers and continues through manufacturing (under GMP) and on to delivery of the product to the final customer or patient.

The supply chain is becoming more complex and global, raising serious practical questions about where the supply chain starts and ends, and precisely where control must be focused to guarantee quality all the way from ingredients to the final medicine. The more global and complex the distribution network, the more difficult it is to ensure that goods follow approved routes, are transported by approved and trained delivery drivers, and that records are properly maintained and quality is assured at every point along the pharmaceutical supply chain.

The global growth of counterfeiting, not only of finished products but also of APIs, is a major issue for the industry. The implementation of GDP is essential for keeping counterfeits out of the legitimate supply chain/distribution network, and lapses in GDP can leave any pharmaceutical supply chain vulnerable to counterfeits.

Hence, good distribution practice remains an essential aspect of compliance for all pharmaceutical products as raw material and products are transported and delivered on a global and local basis.

The pharmaceutical industry in Ireland

Ireland is one of the leading international locations for the life science industry, which spans pharmaceuticals, chemicals, diagnostics, medical devices and biotechnology. It generates over 50% of our exports, making Ireland the largest net exporter of medicines globally. Ireland is home to 13 of the top 15 companies in the world and manufactures nine of the world’s top 15 medicines. In 2008, there were over 24,500 people employed in the sector producing exports of over €44 billion.

Globally, the sector has been expanding by 5-6% per annum since the turn of the decade, and last year it recorded global sales of $745bn. By comparison, exports of life sciences products from Ireland have more than doubled in the same time frame and now account for 9% of global sales.

Therefore, it is essential that the heart of the Irish economy keeps beating by ensuring a consistent, efficient and safe supply chain for the pharmaceutical industry, which will only bring benefits to Ireland in the form of more investment, more businesses and more employment.

Good distribution practice

The World Health Organisation defines GDP as “that part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen counterfeit, sub-standard, adulterated, and/or misbranded pharmaceutical products”. The critical need to establish controls at all points of the supply chain is an increasing challenge for all pharmaceutical companies and their partners in handling and transporting medicines globally.

As previously stated, the GMP manufacturer licence holder is fully responsible to ensure that any third party contractor involved in transportation and storage is fully compliant with the terms of their licence.

By dealing with an accredited GDP Passport service provider, the manufacturer is ensuring that only bona fide operators are transporting, handling and storing their products in accordance with the regulator’s guidelines and ultimately helping to ensure patient safety.

A matter of increasing concern internationally

Counterfeit, unapproved, illegally imported, stolen counterfeit, adulterated, misbranded. These are all words which are becoming an increasing concern for governments, regulators and international health organisations. The rapid growth of counterfeit medicines that can be potentially lethal for the final consumer has seen a strong international reaction demanding more controls and security in the supply chain of pharmaceutical products to ensure that the final consumer receives the products safely.

At the beginning of 2008, the World Health Organisation (WHO) published a document titled Good Distribution Practices (GDP) for Pharmaceutical Products currently being discussed. This guidance is the counterpart of the document Good Trade and Distribution Practices for Pharmaceutical Starting Material, which was published by the WHO in 2003.

At a European level, the EU published its Guidelines of Good Distribution Practice of Medicine Products for Human Use (94/063/3) dating back to 1992.

The International Air Transport Association (IATA) introduced a new set of regulations for airlines and ground handlers on July 1st, 2009 to counter a pharmaceutical industry report that suggested that 50% of temperature deviations occur when the consignments are in the hands of the airlines and their facilities.

Within the GDP principles from the WHO it is stated that “the principles of GDP should be included in national legislation and guidelines for the distribution of pharmaceuticals products… as a means of establishing minimum standards”. This shows us the importance that GDP is receiving and also gives a hint of the way legislators will follow.

GDP Passport from the IEA

The Irish Exporters Association (IEA), assisting the Irish export sector to improve its competitiveness for over 58 years, saw the need to keep Ireland as a world leader in the pharmaceutical sector and the importance that this sector has for the Irish economy. Born from the need for all stakeholders involved in the life science industry to ensure supply chain integrity and final consumer safety, the IEA, in close collaboration with the Health Products Regulatory Authority (HPRA – formerly the IMB), drew up the Good Distribution Practices Passport Scheme, with the main objective of helping to ensure that Ireland remains the preferred location for life sciences companies to develop, manufacture and distribute their products internationally.

The GDP Passport from the IEA is the first of its kind and ensures compliance and safety throughout the whole supply chain. Manufacturers then can ensure that their products are transported, stored and handled according the GMP and GDP regulations and guidelines by dealing with GDP Passport holders.

The code is focused on providing training courses to all levels of personnel involved in the supply chain. The key to success is the full suite of standardised and certified training, which is to be undertaken by all those engaged either directly by the manufacturer or indirectly by the service provider in distribution activities, as stated in WHO Good Distribution Practices for Pharmaceutical Products, section 7.1.

The training needed to become a GDP Passport holder is outlined below:

  • The appointment of a GDP Champion, who must have completed an intensive three-day GDP training module;
  • All relevant operational staff must complete the one-day GDP Introduction Programme;
  • All drivers involved in transportation and handling of pharmaceutical products must complete a two-Hour Driver Training course.

The industry has also recognised the need for a compliant supply chain for pharmaceutical products, and the GDP Passport was enthusiastically welcomed when it was launched in October 2009 by Patrick O’Mahony, CEO of the Irish Medicine Board.

Indeed, several companies, both indigenous and international, have already signed up to the GDP Passport to undergo the training required, and the IEA has already awarded two companies with the GDP Passport.

In 2010, a further group of companies will have met the requirements and will be awarded with the GDP Passport, making Ireland the leader in pharmaceutical supply chain compliance.

Business opportunity

The GDP Passport provides to the industry quality and compliance throughout the whole supply chain, bringing Ireland to the next level of security, quality and compliance in the supply chain for the pharmaceutical and healthcare industry.

In the current economic climate, a key milestone must be to ensure that Irish companies make the most of the competitive advantages they currently have, and the life sciences industry is, without any doubt, a stronghold for the Irish economy. Thus it is vital that this advantage is kept and improved so Ireland can become the first choice for life sciences companies when it comes to establishing new manufacture centres from which to distribute worldwide.

To sum up, the GDP Passport benefits not just manufacturing and logistics companies, but the whole Irish economy.

Raul Molina is manager of Life Sciences Ireland, part of the Irish Exporters Association.

Ciaran Brady is managing director of PLS Pharma.

Email: enquiries@plspharma.com

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