| Service
Details For
your Internal Customers, your documentation should be
clear, consistent, accessible and user friendly:
For External Customers, your documentation should be
compliant
with all the regulations, including EU, FDA requirements.
 We can support by
preparing reviewing or training on following
documentation processes
• SOP’s
• Specifications
• Batch Manufacturing Records
• Equipment IQ, OQ and PQ
• Validation
• Technical report writing
• Manuals
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News
Annex
19 'Reference and Retention Samples' of Volume 4,
The EMEA Volume 4 of EU 'Guidelines to Good
Manufacturing Practice
Medicinal Products for Human and Veterinary Use',
is now in operation since June 2006
http://ec.europa.eu/en terprise/pharmaceutical
s/eudralex/homev4.htm |
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