PT  - JOURNAL ARTICLE
AU  - John R. Sharp
TI  - British GMP’s: Philosophy and Interpretation
DP  - 1982 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 19--22
VI  - 36
IP  - 1
4099  - http://journal.pda.org/content/36/1/19.short
4100  - http://journal.pda.org/content/36/1/19.full
SO  - PDA J Pharm Sci Technol1982 Jan 01; 36
AB  - This paper examines the philosophy underlying the U.K. Guide to Good Pharmaceutical Manufacturing Practice (the Orange Guide), and its interpretation, in the context of the approach to inspection adopted by the U.K. Medicines Inspectorate. In order to illuminate that context, the background to inspection in the U.K. is outlined, with brief mention of the legal framework and a discussion of the nature, recruitment, and training of Medicines Inspectors. The genesis of the Orange Guide is considered, and the interpretation of the guide is considered generally, and with particular reference to the section on Sterile Products Manufacture. The paper will also examine the procedures employed by the Inspectorate when inspecting U.S. facilities for approving export of drugs to the U.K.