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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-2) Sept 2007 |
| Short Title: | PI 024-2 |
| Internet: | http://www.picscheme.org/publis/recommandations/PI-2AideMemoires 4520144n 4520144iotech.pdf |
| Origin/Publisher: | Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org |
| Content: | The aide memoires applies to biotech products and classical biological products for human use, but could also be used for gene-therapy and cell-therapy products. It includes also products for use in clinical trials.
The aide memoires should be considered as a non-exhaustive list of areas to be looked at during an inspection. |
| Document Type: | Guide |
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