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Recently, drugs contaminated with microbial have raised public concern on the quality of pharmaceutical products.  
Good Manufacturing Practice (GMP) is a worldwide recognized quality control system for various products. Pharmaceutical products, as high quality demanding product, are expected to meet with GMP standard. To assure the degree of cleanness in the manufacturing process, microbial evaluation of harmful microorganisms in the finished product is a necessary measurement. It also acts as a key indicator for the finished product quality.
Microbial examination method in United States Pharmacopeia – USP <61> and USP<62>, is a harmonized method to European Pharmacopeia (EuP), which will be effective on 1 May 2009. It is applicable for quality assurance on various types of pharmaceutical products. According to pharmacopeia, drugs with different administration routes have specific microbial requirements. Below table listed out part of the necessary microbial check.
100100Route of AdministrationNecessary Microbial Check Non-aqueous preparations
for oral use
(Tablet, capsule etc.)
or Aqueous preparations
for oral use

Total plate count  Yeast and mould  Escherichia coli   Topical productTotal plate countYeast and mouldStaphylococcus aureusPseudomonas aeruginosa Vaginal useTotal plate countYeast and mouldStaphylococcus aureusPseudomonas aeruginosaCandida albicans Inhalation use (special
requirements apply to liquid preparations for nebulisation)Total plate countYeast and mouldStaphylococcus aureusPseudomonas aeruginosaBile-tolerant gram-negative bacteria We are delighted to offer microbial contamination tests on different types of drugs. If you are eager to proof the high quality and safety of your pharmaceutical products, contact us now!

Alan Ng (Life Science)
t + 852 2609 9611 (ext 3353)
f + 852 2603 7577
Amy Hui (Life Science)
t + 852 2609 9600 (ext 1862)
f + 852 2603 7577

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.