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Open Access Lonza Error Prevention System (EPS) – Changing Human Performance in Pharmaceutical Operations

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Errors are a part of life. With human errors accounting for approximately 50% of quality incidents and related problems within the pharmaceutical industry, the need to improve human performance in manufacturing operations is obvious. The purpose of this article is to describe error-proofing ways of structuring and writing knowledge documents, procedures, batch records, as well as practices for structuring, conducting, and documenting training to assure competence. These practices are recommended for adoption to shift the current 'training for compliance' paradigm to a 'training for competence' paradigm. It will also be demonstrated that a training for competence focus achieves GMP compliance. Results at Lonza have been encouraging, with human error-related quality deviations and non-conformities reduced by more than 40% across 13 sites globally within the first two years of the implementation of its Error Prevention System.

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Keywords: ERROR PREVENTION; GMP; HUMAN PERFORMANCE; PROCEDURES; TRAINING FOR COMPETENCE

Document Type: Research Article

Affiliations: 1: Lonza AG, Lonzastrasse, CH-3930 Visp, Switzerland 2: Lonza AG, Lonzastrasse, CH-3930 Visp, Switzerland;, Email: [email protected] 3: Lonza Biologics plc, 640 Ajax Avenue SL1 4DH Slough, UK 4: BioPhorum Operations Group (BPOG) Westbrook Court, Sharrow Vale Road Sheffield, S11 8YZ UK

Publication date: 2016-09-01

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  • International Journal for Chemistry and Official Membership Journal of the Swiss Chemical Society (SCS) and its Divisions

    CHIMIA, a scientific journal for chemistry in the broadest sense, is published 10 times a year and covers the interests of a wide and diverse readership. Contributions from all fields of chemistry and related areas are considered for publication in the form of Review Articles and Notes. A characteristic feature of CHIMIA are the thematic issues, each devoted to an area of great current significance.

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