At Pace Analytical we understand the importance of keeping up with changes in the marketplace. On March 1, 2019, a revision of USP <467>, Residual Solvents, will become effective. This revision clarifies verification and validation requirements for use of the monograph for Class 1, 2, and 3 residual solvent determination in compendial and non-compendial materials. As part of the revision, USP <1467> has also been introduced to delineate verification and validation requirements. This chapter is also effective March 1, 2019.
Pace Analytical Life Sciences (PLS) is prepared for the revision of USP <467>, and we are ready to move forward with any related projects you may have. Prior to this revision, PLS has routinely performed compendial verifications (CVs) on many compendial materials. In most cases, those compendial verifications already meet the requirements of revised USP <1467> to show that the methodology is suitable in the product matrix. PLS will continue to document these verifications in a cGMP complaint manner for samples submitted.
For compendial materials that are new to PLS or that may not have had a sufficient CV, PLS is meeting the requirements of USP <1467> by performing a verification and sample analysis in the same analytical run. The verification is documented in a cGMP compliant manner. These self-verifying analyses save time and cost for PLS and our clients.
PLS can also perform validations for products or alternative methods that meet USP <1467> requirements. We are prepared and ready to help our clients meet the revised requirements of USP <467>. Please feel free to reach out to any of our experts.
Contact:
Jim Wheeler
james.wheeler@pacelabs.com
612-360-0597