Bewertung des GMP-Status von Lohnherstellern mittels einer Kennzahl
Global Quality Services, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim a. Rh.
Within 2 years, September 2007 until December 2009, a total of 11 domestic and foreign contract manufacturers, working for Boehringer Ingelheim, launch and production site Pharma/Germany, were audited. The majority of the contract manufacturers been audited employed between 200–300 employees and only 2 of 11 contract manufacturers been audited employed less than 100 employees. The duration of the audits performed varied between 2–4 “man days” and the audits were conducted by experienced auditors according to a pre-given template in order to reach the highest possible level of standardisation which enabled the auditor(s) to compare the audited contract manufacturers with each other. In order to generate a “management compatible” (GMP) percentage code (%) with which the “GMP standard” of the contract manufacturers been audited could be calculated, a mathematical tool was used, which has been published earlier to assess results of GMP self inspections . The mathematical tool been published earlier was improved in such a way that the “audit intensity” of the respective GMP areas, e. g. warehouse, production, QC laboratory, etc. was also assessed, thus an “overall grade” could be generated. The individual percentage codes (GMP Standard) varied between 65 and 88 %, only in one case the result was below 30 %. The results corresponded, as expected, with the duration of the audit: The shorter the audit period, the better the result. The author also tried to correlate the given results with the audit total number of employees working in the “Q environment” of the individual companies: A correlation was seen, even only a few data were available.
pharmind 2010, Nr. 12, Seite 2067