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Blog Posted in avatar   Tim Sandle's Blog

Quality and Compliance Excellence in Pharmaceuticals

blog:17587:2::0
By Tim Sandle
Posted Jul 20, 2012 in Science
Achieving Quality and Compliance Excellence in Pharmaceuticals" is a new GMP book edited by Madhu Raju Saghee.
The book covers such topics as Global GMP requirements for pharmaceuticals, CAPA management, OOS investigations, risk management, compliance aspects of sterile manufacturing, training, FDA concerns, and validation. A full list of the chapters can be found here.
The publishers have made a chapter available for review, relating to compliance metrics. This can be read here.
For those who are interested in my work, I have co-authored three chapters for the book. These are:
Sandle, T. and Lamba, S. S. (2012). 'Effectively Incorporating Quality Risk Management into Quality Systems' in Saghee, M.R. (Ed.) Achieving Quality and Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide, Business Horizons: New Delhi, India, pp89-128
Sandle, T. (2012). 'Qualification and Validation' in Saghee, M.R. (Ed.) Achieving Quality and Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide, Business Horizons: New Delhi, India, pp169-206
Sandle, T. and Saghee, M.R. (2012). 'Compliance Aspects of Sterile Manufacturing' in Saghee, M.R. (Ed.) Achieving Quality and Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide, Business Horizons: New Delhi, India, pp517-560

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