Masterarbeit

Current CMC Variation Regulation, change-control, and compliance - outline of a proposed CMC change implementation risk assessment & planning concept that embraces regulatory premises, supply chain forecasting, and quality systems

Noel Bettinville (2014)

Summary
Language: English
The CMC organization of a pharmaceutical company consists of a self-contained entity embedded into an intrinsic quality control system with autonomous loops for feed-back control. Within, the CMC organization is split into centers of competencies, i.e. into functional departments. Among those functional departments there are departments employing scientific experts whose job is to develop, engineer, and qualify the manufacturing process, and departments employing managerial experts whose job is to ensure compliance of the pharmaceutical’s quality with the company’s policies and with country-specific pharmaceutical legislations. A particular regard is on those experts whose primary goal is to guarantee the uninterrupted, foreseeable supply to patients of licensed products which in their life-cycle undergo changes in chemistry, manufacturing and control (CMC).
The CMC change implementation risk assessment & planning concept proposed herein promotes interdepartmental cooperation for the elucidation of the origin and meaning of risk values derived from the risk assessment made by the Global Lead CMC regulatory affairs manager for a specific CMC change and also from the outcome of the risk assessment made by the Global Lead supply chain manager and from the local change control manager (quality assurance), and integrates the pool of risk values to obtain a reasonable and mutually agreed final value for the parameter ‘time-to-success’. The Failure Mode Effects Analysis (FMEA) tool is used for this exercise.
The prerequisite for a proper management of a CMC change project, from initiating the intent and to the logistical implementation, is the individual stakeholder’s awareness of either the differences or the overlap in the understanding of the notion of a CMC change project being ‘successfully concluded’. It usually is assumed that the implementation of a CMC change is chaperoned with throughout regulatory oversight up to and including the operation of logistical implementation. It is however often neglected that managing regulatory compliance and guaranteeing the uninterrupted, foreseeable supply to patients implicates the cooperation of individuals with fundamentally different professional scopes. As a concequence, the notion of ‘successfully concluded’ has different meanings and thus, the success contains a component of risk for failure. This examination reveals that the risk values derived from assessments made by the individual functional stakeholders, compared to the integrated pool of risk values, diverge in the weighting of the parameter ‘time-to-success’. The examination will conclude into a concept valuable for managing CMC change implementation risk assessment & planning with a better risk control.
Pages: 49