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Pharmaceutical Testing

Meet safety and quality standards for pharmaceutical products

WHAT IS PHARMACEUTICAL TESTING?

In the pharmaceutical industry, strict standards exist to ensure the safe consumption and manufacture of drugs. Amid the dynamic industry landscape, pharmaceutical companies which develop, produce, and market drugs face intense pressure to increase and maximize profits. 

Contamination of drugs and pharmaceutical products can pose serious health hazards. Regular plant environmental monitoring is essential to prevent contamination during the production process of drugs. The pharmaceutical companies must ensure their products and processes meet relevant safety and quality standards and fulfil the demands for regulatory compliance. This compliance is necessary to prevent product adulteration and microbial contamination, as public health and safety is at stake.

In addition, the rising demands and expectations of consumers for better drug products, and the limited patent lifespan for manufacturers to profit from new products, further exacerbates the challenges of the pharmaceutical industry.

WHY IS PHARMACEUTICAL TESTING IMPORTANT?

A company will incur huge losses when their pharmaceutical products are recalled. These include the loss of sales, reduced customer confidence, damage to brand reputation, lawsuits filed by consumers and government authorities etc.

As such, all pharmaceutical manufacturers must thoroughly conduct pharmaceutical testing or analysis of their materials, processes, equipment, techniques, environments and provide staff training, in order to ensure their final products are consistent, safe and effective

TÜV SÜD PHARMACEUTICAL TESTING SERVICES

  • Chemical analysis and testing
    • Dissolution test
    • Dissolution Profile
    • Uniformity of content or weight
    • Loss on drying
    • Identification by IR spectrophotometer
    • Heavy metals / elemental analysis
    • Disintegration test
    • Assay by HPLC
    • Relative substances or impurity
    • Stabilities study
    • Identification by UV / Vis spectrophotometer
  • Environmental Monitoring
    • Microbial monitoring
    • Cleanroom air evaluation
    • Air quality monitoring
    • Airborne particle count
    • Gas analysis
    • Gas pipeline cleanliness
    • Process water and trade effluent monitoring
    • Purified and untreated water
  • Microbiological testing
    • Anti-microbial effectiveness of disinfectants
    • Preservative challenge test
    • Spore count of biological indicators
  • Preclinic testing services
    • Carcinogenicity
    • Genotoxicity
    • Single dose toxicity
    • Repeat dose toxicity
    • Reproductive toxicity

TÜV SÜD FACILITIES

TÜV SÜD is equipped with the following facilities to meet the demands of the industry:

  • Liquid chromatograph with tandem mass spectrometer (LC-MSMS)
  • Gas chromatograph – mass spectrometers (GC-MS)
  • Gas chromatographs (GC) with various detectors
  • High performance liquid chromatographs (HPLC) with various detectors
  • Inductively coupled plasma – mass spectrometer (ICP-MS)
  • Inductively coupled plasma – atomic emission spectrometer (ICP-AES)
  • Ultraviolet/visible spectrophotometer (UV/Vis)
  • Fourier transform infra-red spectrophotometer (FT-IR)
  • Dissolution test apparatus
  • Disintegration test apparatus
  • Total organic carbon analyser (TOC)
  • Ion chromatographs (IC)
  • Scanning electron microscope with EDX
  • Environmental chambers
  • Karl Fischer titrator

PRODUCTS TESTED 

  • Tablets and pills e.g. oral contraceptive pills, deworming tablets, antibiotic tablets, etc.
  • Injectables e.g. contraceptives, insulin, etc.
  • Capsules
  • Cream and ointments
  • Excipients
  • Oral rehydration salts 

ACCREDITATION AND RECOGNITION

TÜV SÜD laboratories are accredited to the requirements of ISO 17025 by the Singapore Laboratory Accreditation Scheme (SAC-SINGLAS).

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