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EU GMPs
   
Basic EU GMPs Chapter 1 - 9
$6.90
978-1-935131-00-7
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with Glossary
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $6.90 $6.80 $6.50 $5.90 $4.90
   
Basic EU GMPs with US Standard GMPs
$12.90
978-1-935131-02-1
5 Book Minimum! Basic EU GMPs and US Standard GMP Combination including EU Chapters 1 through 9, US 21 CFR Parts 11, 210/211, 820 and ICH Q7 (Annex 18 / Part II)
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $12.90 $12.80 $12.50 $11.00 $9.90
   
Basic EU and US GMPs with ICH Q7, Q8, Q9 and Q10
$13.90
978-1-935131-96-0
The EU GMPs include Chapters 1-9 and the US GMP includes parts 11, 210/211, and 820 - Combined with the ICH Quality Guidance creates a nice quality driven GMP reference manual.
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $13.90 $13.75 $13.50 $12.90 $11.90
   
Basic EU GMPs with Annex 11, 15, 16 and ICH Q7
$10.90
978-1-935131-97-7
5 Book Minimum! Basic GMPs Chapter 1 through 9 with Annex 11 Computerized Systems - Annex 15 Qualification and Validation - Annex 16 Certification by a Qualified Person and Batch Release - Annex 18 Q7 APIs
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $10.90 $10.75 $10.50 $9.90 $8.90
   
Basic EU GMPs with Annex 11, 15, 16, 18, 19
$11.50
978-1-935131-98-4
5 Book Minimum! Basic GMPs Chapter 1 through 9 with Annex 11 Computerized Systems - Annex 15 Qualification and Validation - Annex 16 Certification by a Qualified Person and Batch Release - Annex 18 Q7 APIs and Annex 19 Reference and Retention Samples
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $11.90 $11.75 $11.50 $10.90 $9.90
   
Basic EU GMPs with Annex 1 Sterile Medicinal Products
$9.90
EU GMPs W/Annex 1
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 1 Sterile Medicinal Products
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 2 Biological
$9.90
EU GMPs W/Annex 2
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 2 Biological Medicinal Products
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 3 RadioPharma
$9.90
EU GMPs W/Annex 3
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 3 RadioPharmaceuticals
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 4 Vet. products other than Immuno
$9.90
EU GMPs W/Annex 4
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 4 Veterinary Medicinal Products other than Immunological
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 5 Immunolgical Vet. Products
$9.90
EU GMPs W/Annex 5
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 5 Immunological Veterinary Medicinal Products
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products
$9.90
EU GMPs W/Annex 7
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 7 Manufacturer of Herbal Medicinal Products
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 8 Sampling of Starting and Packaging Materials
$9.90
EU GMPs W/Annex 8
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 8 Sampling of Starting and Packaging Materials
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments
$9.90
EU GMPs W/Annex 9
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 9 Manufacturer of Liquids, Creams and Ointments
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 10 Inhalation Products
$9.90
EU GMP W/Annex 10
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 10 Manufacturer of Pressurized Metered dose Aerosol Preparations for Inhalation
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 11 Computerized Systems
$9.90
EU GMP W/Annex 11
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 11 Computerized Systems
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 12 Ionizing Radiation
$9.90
EU GMPs W/Annex 12
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 12 Use of Ionizing Radiation in the Manufacturer of Medicinal Products
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 13 Investigational medicinal Products
$9.90
EU GMPs W/Annex 13
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 13 Manufacturer of Investigational medicinal Products
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 14 Human Blood or Plasma Products
$9.90
EU GMPs W/Annex 14
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 14 Manufacture of medicinal Products derived from Human Blood or Plasma
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 15 Qualification and Validation
$9.90
EU GMPs W/Annex 15
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 15 Qualification and Validation
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 16 Qualified Person and Batch Release
$9.90
EU GMPs W/Annex 16
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 16 Certification by a Qualified Person and Batch Release
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annex 17 Parametric Release
$9.90
EU GMPs W/Annex 17
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 17 Parametric Release
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Q7 (Annex 18/Part II)
$9.90
978-1-935131-0
5 Book Minimum! Basic GMPs Chapter 1 through 9 with ICH Q7 - (Part II from Annex 18) Basic Requirements for Active Substances used as Starting Materials
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.50 $8.90 $7.90
   
Basic EU GMPs with Annex 19 Reference and Retention Samples
$9.90
EU GMPs W/Annex 19
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 19 Reference and Retention Samples
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with Annexes 11 and 15
$10.90
978-1-935131-99-1
5 Book Minimum! Basic GMPs Chapter 1 through 9 with Annex 11 Computerized Systems - Annex 15 Qualification and Validation
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $10.90 $10.75 $10.25 $9.75 $9.00
   
Basic EU - US GMPs with Annex 1
$13.25
978-1-935131-55-7
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.
Quantity
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $13.25 $12.90 $11.90 $10.90 $9.90
   
Basic EU GMPs with Annex 6 Manufacture of Medicinal Gases
$9.90
EU GMPs W/Annex 6
5 Book Minimum! Basic GMPs Chapter 1 through 9 with annex 6 Manufacturer of Medicinal Gases
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.75 $9.25 $8.50 $7.90
   
Basic EU GMPs with ICH Q7,Q8,Q9 and Q10
$11.90
978-1-935131-01-4
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with ICH Q7 (Annex 18 or Part II), Q8, Q9 and Q10
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $13.90 $13.80 $13.50 $12.90 $10.90
Electronic Systems Master Handbook 1
978-1-935131-15-1
Electronic Systems Master Handbook 1 – Parts 11, Scope and Application, EU Annex 11, EU Annex 15, Electronic Systems Check List, Computerized Systems used in Clinical Investigations.
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $11.90 $11.45 $10.90 $9.90 $8.45

Quantity   
US EU Canadian Medical Device Combination
978-1-935131-28-1
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $29.95 $22.95 $18.70 $15.90 $12.90

Quantity   
   
Basic EU & US GMPs with Annexes 11 and 15
$13.90
978-1-935131-53-3
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 and US GMPs, 11 Electronic Systems, 210/211 Drug GMPs, 820 QSR, with Annex 11 Computerized Systems - Annex 15 Qualification and Validation
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $13.90 $13.75 $13.50 $12.90 $11.90
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