The packaging materials defect evaluation lists are obligatory for conducting efficient and structured quality assurance. Defect evaluation lists provide guidance for the manufacturer or supplier in dealing with the user (customer).
Renowned experts on package testing in the pharmaceutical industry have elaborated extensive and detailed documentation for quality assurance of packaging materials.
The defect evaluation lists are oriented towards GMP rules, pharmacopoeias (EP, USP, JP), statutory requirements and directives, as well as technical standards EN ISO 2859-1, DIN EN ISO 15378, ANSI Z1.4 (formerly MILSTD 105).
Defect classifications, sampling tables and detailed descriptions of the testing methods facilitate practical work.
The focus of this edition of the General Principles is explaining and deriving the sampling tables specified in the respective defect evaluation lists.
Moreover, this volume provides a brief outline of the statistical methods for quality assurance.
This new edition has been fundamentally revised and expanded according to current guidelines, as well as the latest technology and knowledge.
Target groups include the chemical-pharmaceutical industry; cosmetic industry; suppliers; contract manufacturers (production and processing plants); national authorities and inspection authorities.
- Series: Quality Assurance of Pharmaceutical Packaging Materials, Vol. 12
- Authors: Gossl R, Horst S I AKP — Arbeitskreis Packmittel
- ISBN: 978-3-87193-397-4 (print edition) €84,00
- ISBN: 978-3-87193-450-6 (PDF) €84,00
- ISBN: 978-3-87193-446-9 (bundle edition: print and PDF) €126,00
- Bilingual edition (German- English)
- 5th completely revised and enlarged edition 2017
- 24 x 17 cm, 166 pp., Paperback
