Rx-360 Summary of Q&A on WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

Rx-360 has published a Summary of Q&A on WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

WHO has issued a draft Q&A document on their Certification Scheme for Finished Products Moving in International Commerce. The WHO Certification Scheme for finished pharmaceutical products is an international voluntary agreement to provide assurance to countries participating in the Scheme, about the quality of pharmaceutical products moving in international commerce. 

The primary document of the Scheme was the Certificate of Pharmaceutical Product (CPP). The WHO Expert Committee on Specifications for Pharmaceutical Preparations, during its forty-third meeting, recommended that the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce should be reviewed in light of the changing environment, including the rapid globalization of the pharmaceutical manufacturing sector coupled with changes in the make-up of both the regulators and the groups involved in procurement.  In addition, at the time it was also requested that a questions and answers (Q&A) document be developed as an interim measure.

This draft document is an updated collection of questions and answers related to the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce and specifically to the CPP. Questions have been grouped into five separate categories for easier reference.

To view or download the WHO working document can be viewed, click here.

To view or download the Rx-360 Summary, click here.