PDA Draft Technical Report No. 29 - Pharmanet

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PDA Technical Report No. 29Points to Consider forCleaning ValidationDRAFTMarch 30, Pharmaceutical Cleaning Validation Task ForceJames P. Agalloco, Agalloco & AssociatesWill Brame, Rhone-Poulenc RorerBohdan Ferenc, Novartis Pharmaceuticals E. Hall, , Hall & AssociatesKevin Jenkins, Pharmacia & Uphohn, T. LaMagna, Pfizer, E. Madsen, PDA (Chairman)Michael V. Mullen, , Eli Lilly and CompanyDietmar Wagenknecht, Fujisawa USA, M. Wagner, , Wyeth-Lederle Vaccines & PediatricsiiPrefaceThis document provides guidance relative to the validation of cleaning for a broad range of processingsystems and product types within the pharmaceutical industry. This effort commenced in 1991 inconjunction with individuals representing the biotechnology community. Early on it was agreed toseparate the development of cleaning validation guidance into "biotechnology" and "pharmaceutical"segments. The committees worked in parallel for a number of years and shared early drafts to ensurethat what would be produced by each committee would be compatible.

v 7.4 Specific versus Non-Specific Testing..... 29 7.5 Analytical Methods ..... 30

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