Manufacturing Requirements for Excipients Used in Medicines (Review)

Author:

Mironova M. M.,Kovaleva E. L.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology

Reference29 articles.

1. Decree of the Ministry of Industry and Trade of October 23, 2009, “Ratification of the Strategy for the Development of the Pharmaceutical Industry in the Russian Federation in the Period to 2020”.

2. Federal Law No. 61-FZ, “The Circulation of Medicines”, of April 12, 2010.

3. A. P. Meshkovskii, Farmateka, No. 6, 37 – 41 (1998).

4. The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (2006) (accessed online), International Pharmaceutical Excipients Council, http://ipec-europe.org/UPLOADS/IPECPQGGMPGuide2006(1).pdf.

5. World Health Organization (WHO) Technical Report Series, No. 885, 1999, Annex 5: Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients.

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