Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning
| Autor: | Robert G. Sussman, Ester Lovsin Barle, Eileen P. Hayes, Alison M. Pecquet, Lance R. Molnar, Bruce D. Naumann, Patricia A. Weideman, Bryan K. Shipp, Michael J. Olson, Robert A. Jolly, Ellen C. Faria |
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| Rok vydání: | 2016 |
| Předmět: |
Contract manufacturer
Underpinning Process management Drug Industry Best practice Guidelines as Topic 010501 environmental sciences Toxicology Risk Assessment 030226 pharmacology & pharmacy 01 natural sciences 03 medical and health sciences 0302 clinical medicine Occupational Exposure Toxicity Tests Animals Humans Organizational Objectives Medicine Good manufacturing practice Cooperative Behavior Program Development Policy Making Occupational Health 0105 earth and related environmental sciences No-Observed-Adverse-Effect Level Management science business.industry Health Policy Stakeholder General Medicine Identification (information) Pharmaceutical Preparations Key (cryptography) Pharmaceutical manufacturing Interdisciplinary Communication business |
| Zdroj: | Regulatory Toxicology and Pharmacology. 79:S19-S27 |
| ISSN: | 0273-2300 |
| Popis: | This manuscript centers on communication with key stakeholders of the concepts and program goals involved in the application of health-based pharmaceutical cleaning limits. Implementation of health-based cleaning limits, as distinct from other standards such as 1/1000th of the lowest clinical dose, is a concept recently introduced into regulatory domains. While there is a great deal of technical detail in the written framework underpinning the use of Acceptable Daily Exposures (ADEs) in cleaning (for example ISPE, 2010; Sargent et al., 2013), little is available to explain how to practically create a program which meets regulatory needs while also fulfilling good manufacturing practice (GMP) and other expectations. The lack of a harmonized approach for program implementation and communication across stakeholders can ultimately foster inappropriate application of these concepts. Thus, this period in time (2014–2017) could be considered transitional with respect to influencing best practice related to establishing health-based cleaning limits. Suggestions offered in this manuscript are intended to encourage full and accurate communication regarding both scientific and administrative elements of health-based ADE values used in pharmaceutical cleaning practice. This is a large and complex effort that requires: 1) clearly explaining key terms and definitions, 2) identification of stakeholders, 3) assessment of stakeholders' subject matter knowledge, 4) formulation of key messages fit to stakeholder needs, 5) identification of effective and timely means for communication, and 6) allocation of time, energy, and motivation for initiating and carrying through with communications. |
| Databáze: | OpenAIRE |
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