RT Journal Article
SR Electronic
T1 British GMP’s: Philosophy and Interpretation
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 19
OP 22
VO 36
IS 1
A1 Sharp, John R.
YR 1982
UL http://journal.pda.org/content/36/1/19.abstract
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.