✦ LIBER ✦

Validation of analytical methods in compliance with good manufacturing practice: a practical approach

✍ Scribed by Rustichelli, Deborah; Castiglia, Sara; Gunetti, Monica; Mareschi, Katia; Signorino, Elena; Muraro, Michela; Castello, Laura; Sanavio, Fiorella; Leone, Marco; Ferrero, Ivana; Fagioli, Franca

Book ID: 121627066
Publisher: BioMed Central
Year: 2013
Tongue: English
Weight: 731 KB
Volume: 11
Category: Article
ISSN: 1479-5876
DOI: 10.1186/1479-5876-11-197

No coin nor oath required. For personal study only.

📜 SIMILAR VOLUMES

A practical approach for the validation

A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice

✍ Sabrina Soncin; Viviana Lo Cicero; Giuseppe Astori; Gianni Soldati; Mauro Gola; 📂 Article 📅 2009 🏛 BioMed Central 🌐 English ⚖ 387 KB

Analytical procedures validation for goo

Analytical procedures validation for good manufacturing practice (GMP) production of mesenchymal stem cells from different sources

✍ Viganò, M.; Budelli, S.; Spaltro, G.; Montelatici, E.; Montemurro, T.; Baluce, B 📂 Article 📅 2013 🏛 Informa plc 🌐 English ⚖ 39 KB

Analytical Validation of Quantitative Hi

Analytical Validation of Quantitative High-Performance Liquid Chromatographic Methods in Pharmaceutical Analysis: A Practical Approach

✍ Bonfilio, Rudy; Cazedey, Edith Cristina Laignier; Araújo, Magali Benjamim de; Nu 📂 Article 📅 2012 🏛 Taylor and Francis Group 🌐 English ⚖ 248 KB

A practical approach to method validatio

A practical approach to method validation in pharmaceutical analysis

✍ G.P. Carr; J.C. Wahlich 📂 Article 📅 1990 🏛 Elsevier Science 🌐 English ⚖ 396 KB

Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodology is now widely required in support of registration dossiers. Although some attempts are made at defining terms and some vague indications are sometimes provided within these guidelines, no clear advice

Practical Approaches to Method Validatio

Practical Approaches to Method Validation and Essential Instrument Qualification (Chan/Advanced Analytical Validation) || Operational Qualification in Practice for Gas Chromatography Instruments

✍ Chan, Chung Chow; Lam, Herman; Zhang, Xue Ming 📂 Article 📅 2012 🏛 John Wiley & Sons, Inc. ⚖ 731 KB

Pharmaceutical Sciences Encyclopedia (Dr

Pharmaceutical Sciences Encyclopedia (Drug Discovery, Development, and Manufacturing) || Systems-Based Approach to Laboratory Compliance with the Current Good Manufacturing Practice (CGMP) Regulations

✍ Gad, Shayne Cox 📂 Article 📅 2010 🏛 John Wiley & Sons, Inc. ⚖ 570 KB