All analytical testing is performed to satisfy regulatory requirements or business needs. However, regulatory requirements are not the same all over the world. For example, GxP regulations and pharmacopeia requirements associated with the pharmaceutical industry are not harmonized and require interpretation by the laboratory. Additionally, there are differences in how accreditation bodies interpret evidence for ISO accreditation. Fundamentally, this all means that laboratory compliance requirements must satisfy regulations in three areas: – Company Quality Management System—for the supplier or service provider – Development Location—where the product or service is developed – Sales or Export—where the products or services are sold or exported to
Overall, the two basic needs that must be satisfied for fundamental confidence in the analytical results (and scientific or regulatory validity) are the suitability of the:
– Analytical Method (used to test the samples)
– Analytical Instrument (used to run the analytical method)
The suitability of analytical methods is established by testing (validating) the method performance against acceptance criteria that are pre-approved and appropriate to the kind of analysis being performed.
How do you know your analytical results are valid?
This question relates to the layers and information in the data quality triangle, which are universally applicable to laboratories in all industries because it represents good science. However, to answer this question during an audit, all aspects of laboratory compliance need to be considered and included.
Agilent has developed and validated qualification services that are designed to satisfy regulatory requirements.
- Analyst Training
- Suitable Reference Materials
- Method System Suitability Criteria
- Analytical Method Validation
- Software Validation
- Instrument Compliance / Qualification
- Data Integrity / Governance
Download the article to understand how Agilent Resources can Help Laboratories Comply with Regulations