PDA Technical Report No. 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods (single user digital version)
- Published
- Oct 2013
- ISBN
- 9780939459636
- Pages
- 59
- PDA Item Number
- 43510
Premium Members: to claim your annual free technical document download, email membership@pda.org and indicate the document you wish to claim.
- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
Please sign in or become a member to purchase items from the PDA bookstore.
Intended to provide guidance for the successful evaluation, validation, and implementation of alternative and rapid microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality. This technical report was written to establish industry-wide criteria on what constitutes an acceptable alternative or rapid microbiology test to the compendial or classical method and how to prove it to the satisfaction of quality organizations and regulatory agencies.
Available to download
Format: PDF (1 file 692 KB)
Click here to view the digital downloading instruction and Terms of Usage
*To purchase licensing, please contact PDA at info@pda.org.
Click here to purchase paper ship version (Item no. 01033).
Table of Contents
Table of Contents:
Click here to download >>> Table of Contents- Introduction
- Glossary of Terms
- Classical Microbiology and the Move Toward Alternative and Rapid Methods
- Technology Review
- The Validation Process
- Implementation: Guidance on Site Commissioning Versus Initial Validation
- References
Figures and Tables Index