Proposed revisions for General Chapters <232>, <233>, suggested for a May 1, 2014 implementation date, has been deferred. As such, there is no requirement for ANY drug product in the USP-NF to comply with the proposed USP <232>, <233> at this present time.
From The Corner Lab - Blog Posts
In honor of Breast Cancer Awareness Month, we pay tribute to Evelyn H. Lauder, daughter-in-law of Estee Lauder, whose fight for a cure founded the Breast Cancer Awareness Campaign (BCA Campaign) and co-created the iconic pink ribbon. A decade later, the campaign has raised more than $35 Million to fund grants for medical research. To learn more about the BCA Campaign, visit http://www.bcacampaign.com.
Topics: Breast Cancer Awarness
A review of 483's and Warning Letters issued by the FDA, shows ongoing enforcement for USP method verification. Since the issuance of USP <1226>, the FDA has interpreted the term “under actual conditions of use” to be specific to each sample matrix. All USP compendial methods must have verification performed to demonstrate competency in running the method. In other words, you are mandated to prove you can successfully preform the USP method, similarly as you would in a method transfer. If USP tests are outsourced, you should have the CRO perform verification on your specific matrix.
In May 2012 Quantex Laboratories was recognized as the leading analytical CRO in the areas of productivity and regulatory compliance – receiving The CRO Leadership Award. Based upon over 40,000 pharmaceutical and biopharmaceutical executives who were invited to participate in the survey of the CRO industry, Only CROs scoring in the top quartile in each category qualified as CRO Leaders. Quantex was selected by them as a CRO Leader in those categories –beating out every other CRO.
Many raw material suppliers do only a fraction of their business with pharmaceutical, personal care products or cosmetics companies. A raw material thus may have multiple uses. Consequently specifications may be set to ensure consistency of the material from lot to lot. However, the specification boundaries set by a particular supplier, although consistent, can be much wider than those acceptable for GMP manufacturing purposes. In addition, raw material suppliers may use their own internal analytical methods, rather than a compendial method, in support of a COA.