Multiproduct Cleaning Validation: Acceptance Limits for the Carryover of Inactivated API Part I-The Comparable Quality Approach

摘要

An important consideration in multiproduct cleaning validation is to demonstrate that the carryover of the previously manufactured active pharmaceutical ingredient (API) into a batch of the subsequently manufactured product is below an acceptable limit. If, however, the previously manufactured API becomes therapeutically inactive during cleaning, then there is limited value in verifying clearance of the API. Instead, it is more appropriate to demonstrate clearance of inactivated product. This approach is gaining acceptance in the industry. A methodology for evaluating the degree of inactiva-tion of a product during cleaning and setting acceptance limits for the carryover of inactivated product in multiproduct equipment is described. A new approach for justifying acceptance limits for inactivated product, known as the comparable quality (CQ) approach, is described in Part I; the application of this approach to biopharmaceutical cleaning will be described in Part II. The general principles of the CQ approach are applicable to most active pharmaceutical ingredients (APIs).