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CFR Rule Changes by GXPNews


21 CFR Parts 210 - 211 Drug GMP Combinations

Parts 210 & 211 - Drug GMPs
21 CFR Parts 210/211 Pocket Guide — Pharmaceutical Industry GMPs The regulations in this part contain the minimum cGMP for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing or holding of a drug.
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Parts 210/211 with Keyword Index and Part 11
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Parts 210/211 with Keyword Index
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Price $5.95 $5.85 $5.75 $5.45 $4.95
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Parts 11, 210/211 & 820
Parts 11, 210/211 & 820 - The GMP Predicate Rules
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Multi-US GMPs
Parts 11, 58, 210/211, 600,601,610 and 820
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GMP - Good Manufacturing Practice Handbook
Parts 11, 210/211, 820 & ICH Q7
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Price $9.90 $9.80 $9.70 $8.90 $7.90 $6.70 $4.90
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Parts 11 and 210/211
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Part 203 - Prescription Drug Marketing
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Part 205 - Guidelines for Licensing of Wholesale Drug
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PDMA - Parts 11, 203 & 205
Quantity   5 - 99    100+  
Price $5.95 $5.40
5 Book Minimum
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Basic EU GMPs with US Standard GMPs
$12.90
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)
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Quantity   5 - 99    100 - 249    250 - 499    500+  
Price $12.90 $12.80 $12.50 $11.00
   
Basic EU and US GMPs with ICH Q7, Q8, Q9 and Q10
$13.90
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with US 21 CFR Parts 11, 210/211, 820 and ICH Q7 (Annex 18), Q8, Q9 and Q10
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Basic EU & US GMPs with Annexes 11 - 15
$13.90
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
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11, 58 and 820
$6.90
Electronic Records, GLP Part 58 and QSR Part 820
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Basic EU GMPs Chapter 1 - 9
$6.90
5 Book Minimum! Basic EU GMPs Chapter 1 through 9 with Glossary
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