British GMP's: Philosophy and Interpretation
JR Sharp - PDA Journal of Pharmaceutical Science and …, 1982 - journal.pda.org
This paper examines the philosophy underlying the UK Guide to Good Pharmaceutical
Manufacturing Practice (the Orange Guide), and its interpretation, in the context of the …
Manufacturing Practice (the Orange Guide), and its interpretation, in the context of the …
The Monitoring of GMP Compliance in the development of medicinal products in the United Kingdom
J Taylor - Drug Information Journal, 1994 - journals.sagepub.com
There is currently no European Community (EC) directive which requires the inspection and
authorization of the manufacture of medicinal products for use in clinical trials. The United …
authorization of the manufacture of medicinal products for use in clinical trials. The United …
[PDF][PDF] Good practices for computerised systems in regulated “Gxp” environments
PIC Scheme - Pharmaceutical Inspection Convention, PI, 2007 - gxp-academy.org
2. PURPOSE 2.1 The PIC/S Guide to Good Manufacturing Practices is the basis for GMP
inspections. In particular its Annex 11,'Computerised Systems' is used when inspecting such …
inspections. In particular its Annex 11,'Computerised Systems' is used when inspecting such …
Good manufacturing practices (GMP) for medicinal products
JB Karmacharya - Promising Pharmaceuticals, 2014 - books.google.com
The term GMP was introduced to regulate manufacturing and packaging operations in the
pharmaceutical company. Until the mid-1960s, operating procedures for the manufacture of …
pharmaceutical company. Until the mid-1960s, operating procedures for the manufacture of …
The Implementation of European Community Directives Concerning GMP
JL Turner, S Pharm - Drug Information Journal, 1991 - journals.sagepub.com
European Directives will place obligations on member states to introduce legislation
requiring manufacturers and importers to be authorized and to comply with GMP by January …
requiring manufacturers and importers to be authorized and to comply with GMP by January …
Good manufacturing practice inspection in Europe, in light of the New Central Agency and current international agreements
KB Jensen - Drug information journal, 1995 - journals.sagepub.com
This paper covers good manufacturing practice (GMP) inspection in Europe. Inspections
within the European Union and in other countries are discussed. Excerpts of Council …
within the European Union and in other countries are discussed. Excerpts of Council …
[PDF][PDF] Inspections by National Agency for Medicines-part of the EU's medicine control; translation: Sari Jay
E Pelkonen, S Jay - 2004 - julkari.fi
The manufacture of medicines is subject to licence. To ensure that the manufacture of the
medicinal products is appropriate is one part of the evaluation of marketing authorisation …
medicinal products is appropriate is one part of the evaluation of marketing authorisation …
[CITATION][C] Draft Australian regulatory guidelines for GMP clearance for overseas manufacturers
MCG OMQ - 2010 - Australian Government Department …
[CITATION][C] Changes to the good manufacturing practice clearance guidelines of overseas medicine manufacturers.
C Naughton, A Turnill, T Baker - AUSTRALIAN HEALTH LAW BULLETIN, 2007
[CITATION][C] Good Manufacturing Practice Applied to Pilot Plants
HMS Patel - Special Publications of the Royal Society of …, 1997 - London: The Society, 1980-