SGS launches supply chain safety services

"With today's pharmaceutical supply chain stretching from developed to emerging markets, maintaining product safety and quality is a major concern," the firm said.

Ensuring consistent quality standards across one's supplier base is no easy task, and will only become more complex as price pressures force manufacturers to outsource more production to suppliers around the world."

Moreover, the regulatory obligations and consumer expectations facing the pharmaceutical industry are increasing.

Speaking with Outsourcing-Pharma at this year's Interphex trade show in Philadelphia, Eize de Boer, global manager of Life Science Auditing at SGS said that as of the beginning of the year, the company has started offering two types of good manufacturing practice (GMP) auditing service.

The first is for firms who want to outsource their self inspections, which have to be conducted to ensure that all internal quality management systems are in place.

Training internal staff is also a part of this.

The other service is for vendor qualifications, to ensure that a third party that a company may be working with, or considering working with, has all their quality management systems in place.

De Boer said that 90 per cent of its clients are seeking the latter service, and generally speaking, most companies still prefer to conduct vendor audits themselves of sites that will be working on new entities, while they are comfortable entrusting audits of raw materials, excipients, intermediates and active pharmaceutical ingredients suppliers to a third party such as themselves.

De Boer said that the firm is particularly busy undertaking these audits in Asia.

This is hardly surprising, since the vast majority of raw materials, excipients, intermediates and APIs that drug firms in North America and Europe use to manufacture their drugs come from Asia, as well as Latin America.

The company has offices all around the globe from which it uses local auditors, who speak the language and are intimate with the environment, customs, regulations, etc. at a local level, to conduct the inspections.

Following the inspection, SGS presents its customer with an unbiased overview on the vendor's quality systems and adherence to GMP.

"No other company is offering such a service on a global and regional level, this is our differentiator," said de Boer, adding that prior to the availability of the service, pharma companies either had to conduct the audits themselves, or had to use a western-based consultant, or they did not conduct an audit at all.

"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," de Boer said.

"Companies now need to get used to the idea that GMP audits can now be outsoured.

We are validating the programme, building relationships, and are expecting demand to really take off in the next year or two."