Method Development & Validation

Method Development & Validation
Product Description

SGS life science laboratories have extensive knowledge and expertise in developing and validating methods for raw materials, API’s, finished products and cleaning validation.

SGS offers development and documentation of analytical protocols and reports for proprietary and nonproprietary test methods and manufacturing processes in compliance with the ICH Q2 (R1) guideline “Validation of Analytical Procedures: Text and Methodology” and FDA guidelines.

Once a method is validated, it may require transfer. Method transfer may involve comparative testing, co-validation between two sites (Lab-to-Lab), complete or partial revalidation and comprehensive documentation (Transfer Plan, Protocol, Report). Whether SGS is the developing or the receiving laboratory, we can assist you with your method transfer requirements.

Method Development

- Identification
- Assay testing
- Dissolution
- Particle size distribution
- Testing for impurities
- Stability indicating methods
  - Humidity/temperature
  - Temperature
  - pH variation
  - Oxidative and reductive stress
  - Light stressing
  - Microbial testing

Validation

- Accuracy
- Precision
  - Repeatability
  - Intermediate precision
  - Reproducibility
- Specificity
- Detection limit
- Quantitation limit
- Linearity
- Range
- Robustness
- System suitability test

Read more Show less

SGS North America Inc.

  • US
  • 2015
    On CPHI since
View company profile
Sales Markets
Show more Show less

SGS North America Inc.

  • US
  • 2015
    On CPHI since
View company profile

More Products from SGS North America Inc. (15)

  • Biologics Characterization Services

    Product Biologics Characterization Services

    As a pioneer of physicochemical characterization, we offer you unrivaled expertise in protein analysis. Our laboratories helped to develop mass spectrometry (MS) mapping of biotechnology products, together with other mass spectrometry strategies related to protein/glycoprotein analysis, which have become s...
  • Extractables & Leachables Testing

    Product Extractables & Leachables Testing

    The assessment of Extractables and Leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment, as well as, primary and secondary container closures are potential vectors for chemical contaminants. Monomers and polymer additives such as antioxidants, pla...
  • Quality Control Testing

    Product Quality Control Testing

    Analytical chemistry services from SGS provide you with the bio/pharmaceutical expertise and regulatory qualifications to perform the necessary raw material testing, and testing on APIs, finished products, packaging material and medical devices.
  • Analytical Chemistry

    Product Analytical Chemistry

    SGS provides the professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, APIs, finished products, packaging material and medical devices. Well-equipped state-of-the-art laboratories offer comprehensive testing services according to the pharmacopoei...
  • Biologics Characterization

    Product Biologics Characterization

    SGS’ range of services dedicated to biopharmaceutical product characterization bring the most recent developments in testing technology to companies across the globe. In 2010, SGS acquired the M-Scan Group, the world leaders in the application of advanced mass spectrometry
    techniques for protein and c...
  • Microbiological Testing

    Product Microbiological Testing

    SGS is a leader in Microbiology Quality Control testing, providing a complete array of services for the bio/pharmaceutical industry. SGS’ scientists are published and active on the scientific committees of several organizations. Capabilities range from assessment of microbial contamination to confirmat...
  • Biosafety Testing

    Product Biosafety Testing

    In 2012, SGS acquired Vitrology in order to provide a comprehensive range of biosafety services for biologics, including: virology, cell and molecular biology as well as microbiology and electron microscopy. Health Authorities, including the US FDA and the EMA, require biopharmaceuticals to undergo safety ...
  • Stability Studies

    Product Stability Studies

    From study design to storage, monitoring, analytical testing and documentation, SGS offers services to your complete satisfaction. With more than 25 years of experience and currently more than 100,000 samples in storage, SGS has the skills and the capacity to handle your stability projects. SGS can provide...
  • Bioanalytical Testing

    Product Bioanalytical Testing

    As a leading bioanalytical service provider, with GLP/GMP compliant laboratories, we are able to serve pharmaceutical and biopharmaceutical companies of all sizes with a range of tests for drug development at both pre- clinical and clinical stages – from early to late phase. We also develop assays (includi...
  • Package and Container Testing

    Product Package and Container Testing

    SGS is an industry leader in Package and Container Testing (USP, EP, JP, BP), providing full packaging testing for the drug industry. The safety and efficacy of any pharmaceutical product is inextricably linked to its packaging. Containers or closures that do not meet the physical, chemical, or biologi...
  • Clinical Pharmacology Services

    Product Clinical Pharmacology Services

    As one of the largest European Early Development CRO, SGS offers a complete range of Clinical Pharmacology services encompassing:

    - First In Human trials: Single Ascending Dose (SAD) & Multiple Ascending Dose (MAD), combined protocols: SAD/MAD + food + POC
    - Regulatory Phase I trials: D...
  • Phase II-IV Clinical Trial Management

    Product Phase II-IV Clinical Trial Management


    Employing a team of highly trained experts in the latest International guidelines and company SOPs, SGS has conducted over 800 projects including trials with patients in Western, Eastern and Central Europe, Russia, and North America. SGS’ monitoring and management offices are located in the USA, Fran...
show all 15 other products

SGS North America Inc. resources (10)

  • SGS joins with Biophytis to launch international trial of COVID-19 related respiratory failure treatment

    News SGS joins with Biophytis to launch international trial of COVID-19 related respiratory failure treatment

    The CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium.
    7 Jul 2020
  • Bioanalysis Testing Solutions

    Brochure Bioanalysis Testing Solutions

    With over 30 years of experience and operating out of our GLP/GCP compliant laboratories. SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV).

  • Biologics Testing Services

    Brochure Biologics Testing Services

    A full package of Biologics testing services to cGMP standards from early phase characterisation including Biosafety to Quality Control release testing enabling you to outsource your biologics.


  • Extractables & Leachables Testing Services

    Brochure Extractables & Leachables Testing Services

    Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.

  • Biosafety Testing Services

    Brochure Biosafety Testing Services

    Life-saving medicines are heavily regulated during development, manufacture and distribution. To fulfill regulatory requirements, the biopharmaceutical industry is increasingly looking for independent service providers who can deliver comprehensive characterization solutions on one site. SGS’s global center of excellence for cell bank characterization & virus testing is located in the United Kingdom and provides services with ultimate reliability, highest GLP/cGMP quality and scientific expertise.

  • DETECTION OF MYCOPLASMA IN BIOPHARMACEUTICALS VACCINES AND GENE CELL THERAPIES

    Whitepaper DETECTION OF MYCOPLASMA IN BIOPHARMACEUTICALS VACCINES AND GENE CELL THERAPIES

    Mycoplasma are a form of bacteria that are characterized by the absence of a cell wall surrounding the cell membrane. This renders them inert to many familiar antibiotics, including the beta-lactams, whose activity relies on cell wall disruption. Many different mycoplasma are pathogenic in humans, and they are also commonly found as contaminants in cell cultures. Although the contamination does not create turbidity, factors such as cell line growth rates and viral vaccine production can be adversely affected. This clearly poses a problem for processes that involve cell culture, and thus, being able to detect them is important.

  • EXTRACTABLES AND LEACHABLES: DETERMINING RISK IN SINGLE-USE SYSTEMS FOR THE BIOLOGICS INDUSTRY

    Whitepaper EXTRACTABLES AND LEACHABLES: DETERMINING RISK IN SINGLE-USE SYSTEMS FOR THE BIOLOGICS INDUSTRY

    Single-use systems (SUS) are increasingly becoming the norm in biologics development and manufacturing. Around 85% of the pre-commercial biopharmaceutical sector uses SUS and it is increasingly being adopted for commercial manufacturing. SUS have significant advantages but are not without drawbacks. A 2018 survey showed that 73.3% of biologics insiders listed contamination from extractables and leachables to be a major problem.
  • Cell substrate Characterization - Genetic Stability and Identity Testing at SGS

    Whitepaper Cell substrate Characterization - Genetic Stability and Identity Testing at SGS

    Genetic stability and identity testing are key requirements for regulatory approval of therapeutic biological products produced using a cell bank system.

  • COMPLEX GENERIC APIS: A PRIMER

    Whitepaper COMPLEX GENERIC APIS: A PRIMER

    The potential for economic reward associated with the development of complex generic medicines means there has been dramatic growth in the sector in recent years. However, opportunity is not without complexity. Unlike other medicinal products, manufacturers of complex generics cannot rely on textbook characterization or QC testing to prove compliance with regulations.

  • SGS Life Sciences Drug Development Services

    Brochure SGS Life Sciences Drug Development Services

    Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services.