Pharma Collaboration Proposes Retirement of Obsolete Heavy Metals Tests

The analytical techniques given therein (inductively coupled plasma-mass spectroscopy [ICP-MS] and inductively coupled plasma-atomic emission spectroscopy or optical emission spectroscopy [ICP-AES/OES]) are far superior in both detection and quantitation of elemental impurities. Industry representatives were asked to provide information on the outcome of the collated data generated in these exercises, represented as a number of the company's marketed product portfolio, wherein the data gathered to support a risk assessment revealed a need to implement a new assay and specification as a quality control. Deletion of an assay from specifications without replacement with an equivalent or better assay often has a categorization requiring prior approval to do so. [...]in lieu of making numerous submissions to remove the general tests at this time, most manufacturing license holders have chosen to generate internal general method versions of the former compendial text in order for analysts to continue to perform the assays as listed in the existing registered specifications. Elisabeth Corbett is associate director, Global Regulatory Sciences, CMC, Bristol-Myers Squibb; Andrew Teasdale is senior principal scientistimpurity Management & External Advocacy, Astra-Zeneca; Shoreh Shabrang is senior consultant RA CMC, SAABAS LLC; Lina Wong is associate director, Global Quality Assurance, Allergan; and Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.