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European Union GMPs - for Medicinal Products
for
Human and Veterinary Use
- Introduction
- Chapter 1 – Quality Management
- Chapter 2 – Personnel
- Chapter 3 – Premises and Equipment
- Chapter 4 – Documentation
- Chapter 5 – Production
- Chapter 6 – Quality Control
- Chapter 7 – Contract manufacture and Analysis
- Chapter 8 – Complaints and Product Recalls
- Chapter 9 – Self Inspection
- Glossary
Eruopean Union GMP Annex 1 - Sterile Medicinal
Products
US FDA Regulations Title 21 CFR
- Part 11 Electronic Signatures; Electronic
Records
- Parts 210/211 Good Manufacturing Practices
- Part 820 Quality Systems Regulations
International Conferences of Harmonization
- ICH Q7 GMPs for Active Pharmaceutical
Ingredients - (Annex 18)
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EU GMPs Chapter 1 - 9 with US
GMPs Parts 11 Electronic Records, 210/211 Drug GMPs & 820
QSRs with EU Annex 1 - Sterile Medicinal Products.
$13.25 each -
5 Book Minimum!
Custom Logos Available!
If you would like
to add any other Annex to the EU/US GMP, call
856-810-1825.
Other EU GMPs
Combinations:
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EU GMPs + Annex 11 + Annex 15 + Annex 16 +
Annex 18 Q7 - $10.90
...Order Now
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EU GMPs + Annex 8 + Annex 11 + Annex 15 +
Annex 16 + Annex 18 Q7 + Annex 19 - $11.00
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EU GMPs + Annex 11 + Annex 15 + Annex 16 +
Annex 13 - $11.90
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EU GMPs + Standard GMPs - $12.90
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EU GMPs + Standard GMPs + Q8, Q9, & Q10 -
$13.90
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