Drug Quality and Safety at Risk
PHILADELPHIA – 12 March 2008 – With today’s pharmaceutical supply chain stretching from developed to emerging markets, maintaining product quality and safety is a major concern. In addition, the regulatory obligations and consumer expectations facing the pharmaceutical industry are increasing. To address these issues, SGS has launched a new service for the pharmaceutical industry aimed at ensuring product quality and safety at every step of the supply chain. The company’s pharmaceutical good manufacturing practices (GMP) audit solutions address many of the issues facing the industry.
“No product is immune from the issues associated with distributed supply chains and no manufacturer can escape the damage to one’s reputation caused by a product recall. The issues and risks facing the pharmaceutical industry today are no different than any other industry, but the impact to patients and the healthcare sector is significant,” said Dr. Eize de Boer, Global Manager Life Science Auditing, SGS. “The vast majority of the active pharmaceutical ingredients (APIs) and intermediates that drug companies in North America and Europe use to manufacture their drugs come from suppliers in Asia and Latin America. Ensuring consistent quality standards across one’s entire supplier base is no easy task, and it will become more and more complex as price pressure forces manufacturers to outsource more production to suppliers around the world,” he continued.
Keeping on top of the volume of inspections and differing regulatory obligations around the world can easily overwhelm any company’s internal quality control department. Pharmaceutical GMP audits from SGS allow both customers and suppliers to ensure the quality, integrity and safety of ingredients, packaging and the entire supply chain through a combination of compliance monitoring, pre-inspection assessments, gap-auditing, and specialised training and consultancy services.
“Many companies in the pharmaceutical industry are not outsourcing their GMP audits because they are unaware of alternatives to doing it themselves. This does not have to be the case, there is an alternative,” said Ferdinand Dabu, Marketing Director Life Science Services, SGS. “In addition, with our global network of laboratories and experienced staff, we can respond to a wide range of customer needs – from large manufacturers based in North America and Europe who need to ensure the quality of their inputs, to smaller suppliers in Asia and Latin America who must prove that their production processes and quality meet global standards.” he continued.
Representing the broadest network of contract analytical laboratories and independent well-qualified auditors of quality management systems for the pharmaceutical industry, SGS is the ideal partner for companies considering outsourced pharmaceutical GMP audits. Vast technical experience and in-depth knowledge of local and international GMP guidelines means that SGS understands the local environment yet operates in a globally consistent manner.
For more information about pharmaceutical GMP audit solutions from SGS, visit www.sgs.com/pharma-gmp
SGS will be exhibiting at INTERPHEX on March 26-28, 2008 in Philadelphia. INTERPHEX is a leading trade event for manufacturers and service providers in the life sciences industry. SGS will be located at Booth 2218 for the duration of the event. Additionally, SGS will be holding a seminar on GMP Audit Solutions for INTERPHEX attendees on Thursday, March 27 at 2:00 pm in Room 203B. The seminar will be followed by a reception for members of the media.
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 50 000 employees, SGS operates a network of over 1 000 offices and laboratories around the world. To learn more, visit www.sgs.com
For further information, please contact:
Outi Helena Maatta
1 place des Alpes
CH-1211 Geneva, Switzerland
t: +41 22 739 9161
m: +41 79 251 8218