PDA TR43-2013 Identification英文原版资料.pdfVIP

TR-43 Revised: Identification and Classification of Nonconformities in Molded and Tubular Glass Containers, for Pharmaceutical Manufacturers Roger Asselta, Genesis Technical Advisors NE PDA Meeting November 13, 2013 Technical Report No. 43 (Revised) Glass Containers: Specification, Sampling and Nonconformities 1 © 2013 Parenteral Drug Association Introduction Task Force was charted to develop a guideline that could provide a basis for informed quality decisions on incoming glass container visual inspections resulting in: Consistency in terms and specifications More uniform approach in meeting regulatory expectations to deliver high-quality products Technical Report No. 43 (Revised) Glass Containers: Specification, Sampling and Nonconformities 2 © 2013 Parenteral Drug Association History •  In the Spring of 2002 the PDA formed its original Glass Task Force – Charter •  To develop guidelines for the identification and classification of visual nonconformities for glass container items. –  Team Members were cross functional: •  Pharmaceutical Members •  Consultants •  Glass and Machine Manufacturing industries from the United States and Europe. – Technical Report-43 was published in the 4th quarter of 2007. Technical Report No. 43 (Revised) Glass Containers: Specification, Sampling and Nonconformities 3 © 2013 Parenteral Drug Association History •  A second Glass Task Force was formed in the 4th quarter o