The Current Good Manufacturing Practice [21 CFR 211.194(a)] regulations require that test methods used for assessing compliance of pharmaceutical articles with established specifications must meet proper standards of accuracy and reliability. Effective January 1, 2018, General Chapters <232> Elemental Impurities, which specifies limits for the amounts of elemental impurities in drug products, and General Chapters <233> Elemental Impurities, which describes two analytical procedures for the evaluation of the levels of elemental impurities as well as the criteria for acceptable alternative procedures, are replacing General Chapters<231> Heavy Metals. Compliance with the limits specified in these chapters is required for all drug products unless otherwise specified in an individual monograph.
Elemental impurities, such as arsenic (As), cadmium (Cd), lead (Pb), and mercury (Hg), may be naturally present in a final dosage form, added intentionally, or present as a result of variables such as environmental contaminants or reactions with primary packaging components. As such elements are characteristically detrimental to human health and in some cases drug efficacy, their presence must be determined and quantified.
As the scope of these chapters expand, analytical methods developed for such materials need to be verified for their validity prior to use in release lot testing. In order to claim that a method is valid for such use, adequate documentation must be provided that demonstrates the successful completion of method validation for each element of interest, therefore demonstrating procedure is suitable for its intended application(s).
Whitehouse Laboratories acquired two Agilent Technologies 7900 Series ICP-MS to support the increasing demands of Elemental Impurities testing. Equipped with knowledge and expertise, Whitehouse Laboratories provides assurance that validation of methods intended for use in assessing elemental impurities is carried out in accordance with <1225> Validation of Compendial Procedures. Through our internal Method Validations, Whitehouse Laboratories demonstrates that the requirements set forth during Method Validations are met and are equivalent for use to Compendial procedures. Laboratory Management is responsible for verifying that all Method Validations performed internally include checks for accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, and robustness, and that these checks meet all defined criteria. After completion, the validation report is reviewed by laboratory management followed by the final review and approval by the Quality Assurance Unit. At this point, method is considered validated and release lot testing can be executed. Validated methods for routine analysis can then be transferred back to the client site, maintained at Whitehouse Laboratories for the routine analysis of the specific material.
Whitehouse Laboratories extends its distinguished level of quality and expertise to this growing area of service. We are ready!