Category: PDA
2024
Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users
Format:PDF
Language (s):English
Published:08/01/2024
$162
2010
Technical Report No. 47 (TR 47) Preparation of Virus Spikes Used for Virus Clearance Studies
Format:PDF
Language (s):English
Published:02/01/2010
$162
2010
Technical Report No. 48 (TR 48) Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
Format:PDF
Language (s):English
Published:05/01/2010
$162
2010
Technical Report No. 49 (TR 49) Points to Consider for Biotechnology Cleaning Validation
Format:PDF
Language (s):English
Published:07/01/2010
$162
2010
Technical Report No. 50 (TR 50) Alternative Methods for Mycoplasma Testing
Format:PDF
Language (s):English
Published:09/01/2010
$162
2010
Technical Report No. 51 (TR 51) Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use
Format:PDF
Language (s):English
Published:11/01/2010
$162
2011
Technical Report No. 52 (TR 52) Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain
Format:PDF
Language (s):English
Published:08/01/2011
$162
2011
Technical Report No. 53 (TR 53) Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
Format:PDF
Language (s):English
Published:08/01/2011
$162
2012
Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
Format:PDF
Language (s):English
Published:03/01/2012
$162
2013
Technical Report No. 54-2 (TR 54-2) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling
Format:PDF
Language (s):English
Published:06/01/2013
$162
2013
Technical Report No. 54-3 (TR 54-3) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products
Format:PDF
Language (s):English
Published:11/01/2013
$162
2015
Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances
Format:PDF
Language (s):English
Published:01/01/2015
$162
