Pharmaceutical Testing Services

Meet safety and quality standards for pharmaceutical products

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 PRODUCT 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
    • Relative substances or impurity
    • Particulate matters
    • Stabilities study
  • Environmental Monitoring
    • Microbial monitoring
    • Bacteria / Fungus Identification
    • Total Organic Carbon
    • 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
    • Bioburden / Microbial Limit
    • Sterility
    • Antibiotic bioassay
    • Anti-microbial effectiveness of disinfectants
    • Preservative challenge test
    • Spore count of biological indicators
    • Bacterial Endotoxin

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).

 

FREQUENTLY ASKED QUESTIONS

  • What is pharmaceutical release testing? 

    Pharmaceutical release testing is conducted to ensure that the products released for clinical trials and supplied to the market are of optimum quality. 

     

  • What is the purpose of testing pharmaceutical products? 

    Testing of pharmaceutical products is intended to ensure they meet stringent safety and quality standards and regulations. The purpose of this testing is not only to save cost and time for the producer but also to help improve public health. 

     

  • What is the use of pharmaceutical products? 

    Pharmaceutical products are a range of substances helpful in diagnosing, treating, or altering organic functions to aid public health management. 

     

  • What are quality control tests in the pharmaceutical industry? 

    Pharmaceutical quality control testing is a matter of repetitive testing of samples of APIs, excipients or finished products by applying a wide variety of test methods such as pharmacopeia monographs (Ph. Eur, BP, USP, JP) and/or to your specifications. Chemical analysis techniques used include mass spectrometry, HPLC chromatography, Atomic absorption and emission, FTIR and UV spectroscopy. 

     

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