Regulatory Compliance Statements

All regulated results are reported with regulatory compliance statements that indicate the relevant regulation the test was conducted to meet.

As an example, the following compliance statement is commonly applied to cGMP analyses:

These analyses were performed in general compliance with the Laboratory sections of Current Good Manufacturing Practices for bulk pharmaceuticals as defined in 21 CFR 210 and 211.

If any portion of the regulation was not followed in the analysis, such as the use of a method not validated for the product, the exception is duly noted on the report:

These analyses were performed in general compliance with the Laboratory sections of Current Good Manufacturing Practices for bulk pharmaceuticals as defined in 21 CFR 210 and 211, with the following exception:

The analytical method used for the determination of {Analyte} has been validated to a reference material, but has not been validated for your sample.

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All regulated results are reported with regulatory compliance statements that indicate the relevant regulation the test was conducted to meet.

As an example, the following compliance statement is commonly applied to cGMP analyses:

These analyses were performed in general compliance with the Laboratory sections of Current Good Manufacturing Practices for bulk pharmaceuticals as defined in 21 CFR 210 and 211.

If any portion of the regulation was not followed in the analysis, such as the use of a method not validated for the product, the exception is duly noted on the report:

These analyses were performed in general compliance with the Laboratory sections of Current Good Manufacturing Practices for bulk pharmaceuticals as defined in 21 CFR 210 and 211, with the following exception:

The analytical method used for the determination of {Analyte} has been validated to a reference material, but has not been validated for your sample.

Regulatory Compliance Statements