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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdGood Manufacturing Practice
The following articles on this topic have been published in
CRAdvisor (CRA) – the year, issue number
and starting page number for each are listed below:
Back to index |
| 2007 |
|
|
CRA 2007; 184:6 |
Regulatory inspections of a CRO. |
|
CRA 2007; 185:2 |
GMP guidelines on quality risk management undergoes revision. |
|
CRA 2007; 187:1 |
Annex 11 of GMP to be revised. |
|
CRA 2007; 189:8 |
2007 Edition of the 'Orange Guide'. |
| CRA 2007; 190:4 |
How to avoid inspection problems with the product
specification file. |
| CRA 2007; 192:6 |
Coordination of pre-approval GxP inspections. |
| CRA 2007; 195:7 |
News from the DIA conference. |
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|
| 2006 |
|
| CRA 2006; 169:1 |
Grey areas at GCP/GMP interface. |
| CRA 2006; 172:8 |
FDA abandons Phase I GMP plans. |
|
CRA 2006; 177:8 |
FDA orders company to cease manufacturing human cells and tissues. |
|
CRA 2006; 180:8 |
cGMP quality systems guidance. |
|
CRA 2006; 181:6 |
Experiences of regulatory inspections at a CRO. |
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|
| 2005 |
|
| CRA 2005; 144:4 |
European Directives affecting clinical trials in 2005: an
overview. |
| CRA 2005; 147:8 |
Authorisations for manufacturing and import. |
| CRA 2005; 148:6 |
US marshals seize products. |
| CRA 2005; 149:1 |
European Commission Directive on GCP 2005/28/EC now
published. |
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|
| 2004 |
|
| CRA 2004; 123:6 |
New EU GMP Directive. |
| CRA 2004; 130:7 |
Guidance on transitional arrangements for QPs. |
| CRA 2004; 132:5 |
The EC-Japan MRA. |
| CRA 2004; 132:5 |
Revision of Annex 1 of EC GMP. |
| CRA 2004; 132:5 |
Statement on the Qualified Person's discretion. |
| CRA 2004; 134:7 |
FDA awards for two Swiss inspectors. |
| CRA 2004; 134:7 |
New GMP certification in China. |
| CRA 2004; 135:1 |
Long-awaited Commission Directive on GCP released for
consultation. |
| CRA 2004; 141:7 |
FDA regulation of pharmaceutical manufacturing. |
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|
| 2003 |
|
| CRA 2003; 106:5 |
Regulation of pharma-manufacturing. |
| CRA 2003; 106:6 |
German GMP updates now on EMEA website. |
| CRA 2003; 115:8 |
New version of Annex 13 to GMP has been released. |
| CRA 2003; 116:5 |
Updated Good Manufacturing Practice guidance. |
| |
|
| 2002 |
|
| CRA 2002; 81:2 |
New draft of Annex 13 now available. |
| CRA 2002; 83:6 |
Mutual Recognition Agreement closer for GMP. |
| CRA 2002; 89:6 |
First detailed guidelines to support 2001/20/EC Directive
now publicly available. |
| CRA 2002; 91:7 |
EU-Swiss MRA now in force. |
| CRA 2002; 96:6 |
FDA manufacturing initiative. |
| |
|
| 2001 |
|
| CRA 2001; 61:6 |
New ICH guidance. |
| CRA 2001; 75:5 |
EU GCP Directive and IMPs. |
| CRA 2001; 75:6 |
MRA clarification. |
| CRA 2001; 77:6 |
Annex 13 revision expected soon. |
| |
|
| 2000 |
|
| CRA 2000; 40:1 |
Do monitors break the law by collecting trial materials
from the site? |
| CRA 2000; 46:6 |
EU Pharmaceutical and Cosmetics Unit. |
| |
|
| 1999 |
|
| CRA 1999; 24:3 |
All investigational products must comply with GMP. |
| CRA 1999; 24:4 |
Investigational product for trial purposes cannot be sold. |
| |
|
| 1998 |
|
| CRA 1998; 6:1 |
Details of destruction of trial supplies needed. |
| CRA 1998; 9:4 |
Resistance against ruling on destruction of trial
supplies. |
| CRA 1998; 13:5 |
Trial products and labelling. |
| CRA 1998; 14:4 |
A practical approach to the retention of trial materials. |
| CRA 1998; 15:1 |
Annex 13 of the Guide to Good Manufacturing Practice. |