Modern drug testing

Modern drug testing

TÜV SÜD PSB is equipped with modern analytical testing equipments to help companies meet the necessary product quality and validation requirements for drugs and pharmaceutical products. Pharma Asia visited the facility in Singapore to fi nd out more.

With more than 40 years of experience in testing, TÜV SÜD PSB provides a comprehensive range of pharmaceutical testing services covering chemical analysis and testing of pharmaceutical products and raw materials according to BP, USP, and EP methods, microbiological testing, preclinical testing services and environmental monitoring. Its laboratories are also accredited to the requirements of ISO 17025 by the Singapore Laboratory Accreditation Scheme (SAC-SINGLAS). In January 2010, this quality and safety testing, inspection, certification and auditing organization was officially listed as one of WHO’s Prequalified Quality Control Laboratories of Pharmaceuticals. This qualification recognizes that TÜV SÜD PSB’s laboratories are in compliance with recommended standards governing Good Practices for National Pharmaceutical Control Laboratories (GPCL) and Good Manufacturing Practices (GMP) for the testing and analysis of pharmaceutical products.

Testing fertility drugs

According Lim Hwee Jen, Product Manager, Chemical and Materials – Food and Pharmaceuticals, drugs are tested according to international pharmacopeia standards at TÜV SÜD PSB. She took Pharma Asia through the various steps of fertility drug testing using the USP method. The products tested were Levonorgestrel and Ethiny Estradiol tablets.

The process is as follows:

• Prepare a deaerated mixture containing 350 mL of acetonitrile, 150 mL of methanol, and 450 mL of water.

• Prepare a concentration of 15 μg per mL and 3 μg per mL of USP Norgestrel RS and USP Ethinyl Estradiol RS respectively.

• Assay preparation – Transfer 10 tablets, equivalent to about 3 mg of levonorgestrel, to a 200-mL volumetric flask. Dilute with Mobile phase to volume, sonicate to disintegrate the tablets. Centrifuge and filter with 0.45 membrane filter, and use the clear, supernatant.

• Chromatographic system – The liquid chromatograph is equipped with a 215-nm detector and a column that contains packing L7. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak response as directed.

• Separately inject equal volumes of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Building on a strong heritage

Pharma Asia spoke to Chong Kok-Yoong, Vice President, Food and Pharmaceutical Industries, Strategic Business Development, TÜV SÜD PSB, to fi nd out more about the organization:

PA: Tell us more about TÜV SÜD PSB and the customers that you service. Chong:

TÜV SÜD PSB is a 145 year-old company that started in Germany. Today, it is a truly international company with 600 locations worldwide. We are in the CTCT (consulting, training, certification and testing) business-to-business arena. Our customers are organizations and corporations who buy medicines or pharmaceuticals products. Specifically, they are international buying bodies such as UN agencies that buy in bulk. They need these drugs to be tested and verified before they distribute them to various governments of developing countries around the world, such as Cambodia and Myanmar in Southeast Asia. Besides the aid agencies, we also have business from Big Pharma companies. They use us as an external laboratory to complement and support what they do in-house. We provide them independent verification on drugs that they are developing. In most cases, their laboratories are quite tight in terms of schedule so they subcontract to us to ease their workflow.

PA: What kinds of inspection are carried out in your labs? Chong:

Our pharmaceutical testing is fairly wide ranging. At present, we specialize in testing birth control pills and malaria tablets. We check, for example, the concentration of the active ingredient in the drug against what is labeled. Organizations also utilize our services to do packaging and environmental testing. We would check on the functionality and tightness of blister packaging for capsules, for example, to meet a certain standards. They cannot be too loose that damage can occur during transportation. In environmental testing, we would check on the parameters like quality of air in the manufacturing environment.

PA: Tell us more about the international prequalification programme that TÜV SÜD PSB received in 2010? Chong:

This is prestigious as not more than 10 organizations globally have received this accreditation and TÜV SÜD PSB is one of them. In fact, we are the only non-government laboratory to receive this accreditation. The accreditation process was stringent, and took place in two main areas – chemical testing and microbiological testing. We had to show proper documentary evidence on how we conduct a test. Are our personnel trained? Do we have a quality system based on good laboratory practices (GLP)? Meeting these requirements as well as our conformance to the ISO 17025 standard formed the basis of our qualification.

PA: What do you think made the difference for TÜV SÜD PSB in receiving the -qualification? Chong:

We have been in the drug testing business for a long time. We also have a strong reputation in the market for our technical know-how and credibility. I believe that our heritage and previous government links also had a part to play in our qualification. We used to be called SISIR back in the 70’s when we first started as a standards organization in Singapore specializing in various types of testing. From SISIR, the organization became PSB Corporation which was then acquired by TÜV SÜD PSB five years ago. I am sure the TÜV SÜD PSB brand, our network of worldwide locations with a total of 16,000 employees had a part to play in our qualification as well. But we are not resting on our laurels. In terms of future strategic development, we are maintaining and will continue to look for interested parties who need testing services to work with us.