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CPhI Worldwide 2008 brings together pharmaceutical professionals around the globe. This three day event will attract everyone from manufacturers and purchasers of fine chemicals and pharmaceuticals to solution providers, all in search of the latest industry developments.

During September 30 to October 2, SGS will hold a set of mini-seminars about diverse quality control techniques for the pharmaceutical ingredients industry.

Direct Your Extractable and Leachable AssessmentTuesday, September 30, 2008
3:00 pm – 3:30 pm
Presenter: Dr. Andreas Nixdorf, Project Manager
Location: Hall 4.1, Stand D58

In recent years, the requirements for the assessment of substances that can potentially leach into the drug product in the course of its shelf-life have increased considerably. Extractable and leachable studies are designed to ensure that packaging material does not negatively impact the stability and activity of the drug, or even worse actively harm the end user. The presentation will address the relevant aspects of leachables and extractables testing ranging from regulatory requirements to the extractables testing for quality control.

Harmonizing Quality Compliance Within Pharmaceutical Supply ChainsTuesday, September 30, 2008
4:00 pm – 4:30 pm
Presenter: Eize de Boer, Global Manager, GMP Audit solutions
Location: Hall 4.1, Stand D58

The pharmaceutical industry is faced with increasing legislation and guidance on efficacy, quality, and safety during the entire life cycle of their products. As a result, quality and compliance departments in the sector are expected to control compliance of the entire supply chain, from incoming goods to the delivery of final product to the patient. Therefore, the quality management staffs are increasing their focus in the area of internal quality, safety self-inspections, and external vendor qualifications. The presentation will provide an overview of the wide range of outsourced, third-party GMP solutions for the entire pharmaceutical and biotech industries, including drug manufacturers, suppliers and regulators.

Harmonizing Quality Compliance Within Pharmaceutical Supply ChainsWednesday, October 1, 2008
3:00 pm – 3:30 pm
Presenter: Marie Cécile Krief, European Manager, GMP Audit solutions
Location: Hall 4.1, Stand D58

The pharmaceutical industry is faced with increasing legislation and guidance on efficacy, quality, and safety during the entire life cycle of their products. As a result, quality and compliance departments in the sector are expected to control compliance of the entire supply chain, from incoming goods to the delivery of final product to the patient. Therefore, the quality management staffs are increasing their focus in the area of internal quality, safety self-inspections, and external vendor qualifications. The presentation will provide an overview of the wide range of outsourced, third-party GMP solutions for the entire pharmaceutical and biotech industries, including drug manufacturers, suppliers and regulators.

Harmonized Pharmaceutical MicrobiologyThursday, October 2, 2008
2:00 pm – 2:30 pm
Presenter: Dr. Christof Siersdorfer, Project Manager
Location: Hall 4.1, Stand D58

The new United States Pharmacopeia (USP), European Pharmacopeia (EP) and Japanese Pharmacopeia (JP) harmonized microbial limits test method has been available for some time. Although the USP will make it a requirement in May 2009, the EP will already require its use by January 2009. Although these dates are some months out, preparation for the change must begin now to ensure proper implementation. The presentation will assist attendees in performing their own gap analysis.

CPhI Worldwide 2008 will take place on September 30 – October 2 at Messe Frankfurt GmbH, Ludwig-Erhard-Anlage 1, 60327 Frankfurt a. M., Germany.

SGS is the world’s leading inspection, verification, testing and certification company. Recognized as the global benchmark for quality and integrity, we employ over 53,000 people and operate a network of more than 1,000 offices and laboratories around the world. SGS is your partner of choice for clinical research services, GMP compliant quality control of biopharmaceuticals from batch release testing, analysis of bulk products, raw material testing, method development & validation, or standard microbiological testing and for GMP audit solutions and for the related training services.

For more information, please contact:

Ferdinand Dabu
SGS Life Science Services - Quality Control Testing
Website: www.sgs.com/pharmaqc