Transcription of PDA Draft Technical Report No. 29 - Pharmanet
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PDA Draft Technical Report No. 29 - Pharmanet
PDA Technical Report No. 29 Points to Consider forCleaning ValidationDRAFTM arch 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.
PDA Technical Report No. 29 Points to Consider for Cleaning Validation DRAFT March 30, 1998 TR28_002.PDF
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