Method Development and Validation

Compounds Without Protocols

Bureau Veritas provides method development and validation services for a wide variety of compounds for which sampling and analysis protocols are not available. The service is applicable for active pharmaceutical ingredients (APIs), proprietary chemicals, industrial chemicals and intermediates, nanomaterials, as well as products in the client development pipeline. Our services are specific to surface and air sampling.

Learn Why You May Need Method Development

PIE

In addition to Industrial Hygiene methods, Bureau Veritas also develops methodology for the testing of Pharmaceuticals in the Environment (PIE). Our methodology can help ensure that your facility upholds its commitment to the environment and the surrounding communities that would be impacted.

Learn About Pharmaceuticals in the Environment

Method Validation

Industrial hygiene method validation is usually driven by employers who need to understand staff risks associated with exposure to new compounds. Analysis results are used to provide employees with the appropriate protection and working conditions.

Validating Air Sampling Methods

The Bureau Veritas Industrial Hygiene laboratory offers the most advanced instrumentation technologies in High Pressure Chromatography (HPLC), Mass Spectrometry, elemental analysis, optical analysis, and Ion Chromatography. We employ more than 80 professional staff, including Certified Industrial Hygienists (CIH), chemists (Ph.D., MS, and BS levels), and microscopists. We have developed more than 1,000 sampling and analytical methods over the last two decades.

While many of the methods are proprietary, some have been published in peer-reviewed journals, such as the Journal of Occupational and Environmental Hygiene (JOEH) and Journal of Oncology Pharmacy Practice. Our methods are developed in accordance with guidelines from OSHA, NIOSH, and the US EPA, and also meet requirements for US or international product registration.

Following the applicable guidelines, protocols can be customized to meet your project validation requirements. We also provide validation services on existing methods including method transfer, verification and storage stability. Our experts can remediate existing methods to bring those techniques up to current practices. Assuming you do not have a defined method validation protocol for new pharmaceutical application methods, we suggest the following protocols to define scope and validation criteria:

HPLC and HPLC/MS methods
Adaptation of HPLC to HPLC/MS to enhance sensitivity
Adaptation of air sampling methods to surface applications

Method Development and Validation

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